Drug Recalls

Alvogen, Inc. is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches to the consumer level. The reason for the recall is that there is a potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch. This transdermal system is manufactured by Kindeva Drug Delivery L.P., Northridge, CA and is distributed by Alvogen, Inc. as a private label distributor.

There is a possibility that the application of a multi-stacked 25 mcg/h patch could result in serious, life threatening, or fatal respiratory depression. Groups at potential increased risk could include first-time recipients of such patches, children, and the elderly. To date, Alvogen has received one serious adverse event related to this recall.

The product is indicated for the management of severe and persistent pain in opioid-tolerant patients, that requires an extended treatment period with a daily opioid analgesic in opioid-tolerant patients, and for which alternative treatment options are inadequate, and is packaged in primary cartons of five individually wrapped and labeled pouches. The affected Fentanyl Transdermal System lot is:

Lot 108319 of Fentanyl Transdermal System, 25 mcg/h, expiration date 04/2027.

This lot of Fentanyl Transdermal System was distributed nationwide to the pharmacy and patient level. See image examples for lot 108319 and a multi-stacked patch.

Alvogen, Inc. is notifying its distributors and direct customers by certified letter and is arranging for return and replacement of all recalled products. Pharmacies are requested not to dispense any product subject to this recall.

Patients that have product subject to this recall should immediately remove any patch currently in use and contact their health care provider. Patients with unused product should return it to point of purchase for replacement. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

ICU Medical, Inc. is voluntarily recalling one lot each of POTASSIUM CHLORIDE Inj. bags with overwrap labels 10mEq, packaged in cases of POTASSIUM CHLORIDE Inj. 20 mEq, to the user level. ICU medical has received a customer complaint which states that bags of POTASSIUM CHLORIDE Inj. 20 mEq have incorrect overwrap labels which state POTASSIUM CHLORIDE Inj. 10 mEq.

ICU Medical has identified a potential for some of the product overwraps in one lot being mislabeled as 10 mEq (instead of 20 mEq that is contained in the I.V. Bag) of POTASSIUM CHLORIDE due to a manufacturing issue. The 20 mEq, correctly printed on the labeling affixed to the bag, is not visible or not easily visible without manipulation when the 10 mEq overwrap is in place

Risk Statement: If the Health Care provider mistakenly calculates the patient dose using 10 mEq, the patient will receive an overdose of potassium chloride. Severe hyperkalemia after large intravenous overdoses causes neuromuscular dysfunction including muscle weakness, ascending paralysis, listlessness, vertigo, mental confusion, hypotension, cardiac dysrhythmias, or death from cardiac arrest. Premature infants, patients on chronic parenteral nutrition, patients who have a history of cardiac arrythmias, patients with chronic renal insufficiency, patients who have acute renal failure, patients on potassium-sparing diuretics—all are at risk for adverse and potentially fatal outcomes. ICU Medical has not received reports of adverse events associated with this issue to date.

Potassium Chloride Injection 20 mEq and 10 mEq, is indicated in the treatment of potassium deficiency states, when oral replacement is not feasible and is packaged in 100 mL bags. The mislabeled POTASSIUM CHLORIDE Inj. 20 mEq, 100 mL bags contain incorrect overwrap labels with the following information: NDC 0990-7074-26, 200 mEq/L POTASSIUM CHLORIDE Inj. 10 mEq. The lot 1023172 and Exp. Date 31 January 2026 is found on the primary container (see picture below). These mislabeled bags are packaged in cases labeled: NDC 0990-7075-26, CASE PACK 1×24 – 100ML 20MEQ POTASSIUM CHLORIDE INJECTION LOT NO. 1023172, EXP DATE 2026-01.

FOR IMMEDIATE RELEASE – January 24, 2025 – Collegeville, Pennsylvania, Provepharm Inc. is voluntarily recalling lot number 24020027; Expiry Date December 2025 of Phenylephrine hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) at the hospital/institutional level. This recall was initiated based on a customer complaint from a pharmacy after observing a visible black particulate matter found in a single-sealed vial of the product.

Risk Statement:

Administration of an injectable product containing particulate matter may cause local irritation or swelling as a response to the foreign material. If the particulate matter enters the blood vessels, it can travel to various organs and potentially blocking blood vessels in the heart, lungs or brain, leading to serious complications such as stroke or even death. To date, Provepharm Inc. has not received any reports of adverse events or injuries associated with this recall.

Phenylephrine hydrochloride Injection is used for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia and is packaged in 10 mL vial, 1 single dose vial, with NDC code as 81284-213-01.

The product can be identified by product name on carton and vial label and with lot number 24020027 and Exp. Date: Dec 2025 (NDC 81284-213-01) (See enclosed vial label).

Phenylephrine hydrochloride Injection, USP, 10 mg/ mL, was distributed nationwide in the United States to wholesalers.

Provepharm Inc., in collaboration with its recall provider, Sedgwick, is notifying distributors and customers via UPS Ground and coordinating the return of all recalled products.

Astellas Pharma US, Inc. (Head of US Commercial: Michael Petroutsas, “Astellas”) is voluntarily recalling one lot of PROGRAF® 0.5mg (tacrolimus) and one lot of ASTAGRAF XL® 0.5mg (tacrolimus extended-release) capsules to the consumer level. These products are being recalled because bottles may contain empty capsules.

Risk Statement

Transplant patients who consume empty PROGRAF or ASTAGRAF XL capsules may experience initiation of rejection of the transplanted organ, tissue, or cells, due to underimmunosuppression. In the case of life sustaining organ transplants such as a heart transplant (for which there is no permanent substitute such as hemodialysis in the case of a failed kidney transplant) if the transplant fails, the consequences of rejection initiated by ingesting empty capsules may be fatal. To date, Astellas has not received any reports of adverse events related to this recall.

Endo, Inc announced today that one of its operating subsidiaries, Endo USA, Inc., is voluntarily recalling all lots within expiry of Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP) 30mg/30mL (1mg/mL) 30 mL vials, to the consumer level. This product, which pre-dates the 1938 Federal Food, Drug & Cosmetic Act, was never submitted for approval by the FDA, and as such, is an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. In addition, FDA has determined the product to be misbranded with a misleading label similar in appearance to the FDA-approved drug product Adrenalin® (epinephrine injection, USP) (1mg/mL) 30mL vial, also produced by Endo USA, Inc.

Both products are distributed to hospitals and healthcare systems for use by healthcare professionals. The similarity in labeling makes it difficult to distinguish between the non-sterile topical and sterile injectable product which can lead to potential administration errors. This recall does not include the approved Adrenalin® (epinephrine injection, USP) (1mg/mL) 30mL vial.

Risk Statement: Intravenous administration of the unapproved non-sterile topical Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP), instead of the approved sterile Adrenalin® (epinephrine injection, USP) (1mg/mL) 30mL vial for injection, would result in non-fatal serious and/or severe, health outcomes related to delayed or inadequate treatment of the underlying condition (anaphylaxis, hemodynamic instability, hypotension) or infection due to intravenous administration of a non-sterile product. In addition, there is a high probability that intravenous administration of the nasal product will result in patients receiving the wrong dose of epinephrine in emergency situations for serious, life-threatening conditions such as the treatment of anaphylaxis, blood pressure support, and cardiac arrest. If these events are not treated with the correct dose of epinephrine, patients may be at risk for death.

Endo, Inc. (OTCQX: NDOI) (“Endo”) announced today that one of its operating subsidiaries, Endo USA, Inc., is expanding its previously announced voluntary recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) due to potential product carton strength mislabeling.

Specifically, Endo’s ongoing investigation has identified the possibility that the Clonazepam product lots listed below contain a limited number of cartons printed with the incorrect strength and National Drug Code (NDC) code due to an error by a third-party packager. The blister strips and tablets inside the product pack reflect the correct strength for the lot.

STASKA PHARMACEUTICALS, INC. is voluntarily recalling 1 lot of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL, 50mL vials to the user level. This is due to the presence of glass particulates in one lot of vials used in the production of this batch.

The administration of an injectable product containing particulate matter may result in local irritation or swelling. The particulate matter could travel through and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. The frequency and severity of these adverse events could vary depending upon a variety of factors including the size and number of particles in the drug product, patient comorbidities, and the presence or absence of vascular anomalies.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced it is issuing a voluntary recall of one lot of Veklury® (remdesivir) for Injection 100 mg/vial, to the consumer level. Gilead received a customer complaint and confirmed the presence of a glass particle in the vial during the company’s investigation.

Risk Statement: The administration of an injectable product that contains glass particles may result in local irritation or swelling in response to the foreign material. The glass particulate can potentially travel, through the blood vessels, to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. To date, Gilead has not received any reports of adverse events related to this recall.

Princeton, NJ, Bionpharma Inc. is voluntarily recalling (1) single Batch (2310083) of Atovaquone Oral Suspension, 750mg per mL to the consumer level. The product was manufactured by CoreRx, Inc. in Clearwater, FL and distributed by Bionpharma Inc. The product was found to be contaminated with Cohnella bacteria.

Risk Statement: In the population most at risk, immunocompromised population, there is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life threatening infections such as inflammation of the heart and permanent damage to soft tissue. To date, Bionpharma has not received any reports of adverse events related to this recall.

Braun Medical Inc. (B. Braun), is voluntarily recalling two (2) lots of 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers within the United States to the consumer level. The voluntary recall has been initiated due to the potential for particulate matter and fluid leakage of the respective containers.

The affected batches were inadvertently released to the market prior to the completion of the required acceptance activities for embedded particulate matter which may result in leakage. To date, there have been no customer complaints received and there have been no reports of serious injury or death associated with this issue.

Risk Statement: There is a reasonable probability of embolic phenomena such as stroke or ischemia/infarct to other organs and possible infection if these particulates are not sterile that could lead to permanent damage or impairment of body function which could be life-threatening.

Baxter International Inc. (NYSE:BAX) is voluntarily recalling one lot of Heparin Sodium in 0.9% Sodium Chloride Injection to the consumer level due to the potential for elevated endotoxin levels based on issues related to the bacterial endotoxin test specific to lot number N008235.

Use of heparin with higher than acceptable endotoxin levels may lead to significant adverse health consequences ranging from febrile reactions to toxic shock, multi-organ failure and death. To date, Baxter has not received any reports of adverse events related to this issue.

Endo, Inc (OTCQX: NDOI) (“Endo”), announced today that one of its operating subsidiaries, Endo USA, Inc., is voluntarily recalling one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets, which may also appear as Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125 tablets 60-count pack to the consumer level.

The product lot is being recalled due to mislabeling where an incorrect strength appears on the cartons of some packs to show the product strength as 0.125 mg and not 0.25 mg due to an error at a third-party packager. The blister strips inside the product pack reflect the correct strength of 0.25 mg.

Risk Statement: Children and adults who are inadvertently prescribed a two-fold overdose of clonazepam would be at risk for the adverse effects of significant sedation, dizziness, ataxia, and confusion. There is reasonable probability for significant, possibly life-threatening, respiratory depression especially for patients with concomitant pulmonary disease, patients who have prescribed dosing near maximal dosing, and patients also taking other medications that could cause additional respiratory depression. To date, Endo has not received any reports of adverse events associated with this product lot recall.

American Health Packaging on behalf of BluePoint Laboratories is voluntarily recalling 21 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, to the consumer level. The product is being recalled because of failed dissolution.

Risk Statement: The failed dissolution of potassium chloride extended-release capsules may cause high potassium levels, also known as hyperkalemia, which can result in irregular heartbeat that can lead to cardiac arrest. For patients who require chronic use of potassium chloride extended-release oral capsules, especially in those patients with underlying comorbidities or conditions that cause altered excretory mechanisms for potassium such as hypertension, heart failure, or renal dysfunction, there is a reasonable probability of developing hyperkalemia that may lead to a range of severity of adverse events from being asymptomatic to more severe potential life threatening adverse events of hyperkalemia such as cardiac arrythmias, severe muscle weakness, and death. To date, the firm has not received any reports of hyperkalemia or serious adverse events from spontaneous sources related to this recall.

Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ is voluntarily recalling 114 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, to the consumer level. The product is being recalled because of failed dissolution.

Risk Statement: The failed dissolution of potassium chloride extended release capsules may cause high potassium levels, also known as hyperkalemia, which can result in irregular heart beat that can lead to cardiac arrest. For patients who require chronic use of potassium chloride extended-release oral capsules, especially in those patients with underlying comorbidities or conditions that cause altered excretory mechanisms for potassium such as hypertension, heart failure, or renal dysfunction, there is a reasonable probability of developing hyperkalemia that may lead to a range of severity of adverse events from being asymptomatic to more severe potential life threatening adverse events of hyperkalemia such as cardiac arrythmias, severe muscle weakness, and death. To date, the firm has not received any reports of hyperkalemia or serious adverse events from spontaneous sources related to this recall.

Pharmaceuticals today announced the voluntary nationwide recall of two lots of Docetaxel Injection, USP (80 mg per 8 mL multi-dose vials and 160 mg per 16 mL multi-dose vials). The product was distributed by Sagent Pharmaceuticals. Sagent has initiated this voluntary recall of Docetaxel Injection, USP to the User Level as the result of a customer complaint due to potential presence of particulate matter from the stopper in the drug product.

Risk Statement: Intravenous administration of an injectable product that contains particulate matter may result in serious adverse events. Potential complications related to injection of particles include inflammation of a vein, granuloma, and blockage of blood vessels in the heart, lungs or brain which can cause stroke or life-threatening blood clot events. The frequency and severity of these adverse events could vary depending upon a variety of factors including the size and number of particles in the drug product, patient comorbidities (such as age, compromised organ function), and presence or absence of vascular anomalies.

Hospira, Inc., a Pfizer company (“Pfizer”), is voluntarily recalling the lots listed in the table below of Buprenorphine Hydrochloride Injection CarpujectTM Units and Labetalol Hydrochloride Injection, USP CarpujectTM Units to the User level. The recall was initiated due to the potential for incomplete crimp seals; one customer complaint has been received for one leaking unit.

In the event that impacted products are administered to a patient, there is a potential for an increased risk of lack of therapeutic effect and systemic infection that may result in the need for additional medical treatment. To date, Pfizer has not received reports of any relevant adverse events associated with this issue for these lots.

AvKARE, LLC. is voluntarily recalling lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product found during stability testing at a 3rd party lab.

Risk Statement: In the population most at risk, immunocompromised population, there is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life threatening infections such as endocarditis and necrotizing soft tissue infections. To date, AvKARE has not received any reports of adverse events related to this recall.

Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey (Amneal), is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the Consumer Level. Some bottles may have been overfilled which can result in an over potent dosing regimen. The recommended maximum daily dose allowance for this product is up to 2gm/day and patients prescribed a dosing regimen of 500 mg/10mL would exceed this daily allowance, which may be harmful to patients with renal insufficiency. The error occurred during the manual bottle filling stage of manufacturing.

Risk Statement: Adult patients who are prescribed the maximum daily dose of up to 2 grams per day of Vancomycin Hydrochloride for oral solution, USP 250 mg/5mL, may receive up to 4 grams of oral vancomycin per day because of the overfilled bottle. Some patients with inflammatory disorders of the intestinal mucosa also may have significant systemic absorption of vancomycin. These patients may be at risk for the development of adverse reactions associated with higher doses of vancomycin oral solution. Worsening renal function could be associated with electrolyte abnormalities such as high potassium leading to cardiac arrest. To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall.

Eugia US LLC (f/k/a AuroMedics Pharma LLC) has initiated a voluntary recall of lot number 3MC23011 of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) – 10mL Vial to the consumer level due to a customer product complaint for the presence of white particles floating inside of the vial.

Risk Statement: Administration of an injectable product that contains particulate matter may result in local irritation or swelling. If the particulate matter reaches the blood vessels or is injected intravascularly it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. To date, Eugia US LLC has not received any reports of adverse events related to this recall.

Endo International plc announced today that one of its operating companies, Par Pharmaceutical, Inc. (Par), is voluntarily recalling one lot of Treprostinil Injection 20mg/20mL (1mg/mL) to the consumer level. The product is being recalled due to the potential for the presence of silicone particulates in the product solution.

Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. To date, Par has not received any reports of adverse events related to this recall.

Brassica Pharma Pvt. Ltd. is voluntarily recalling Eye Ointment products, distributed nationwide to wholesalers, retailers, and via the product distributor, Walmart, CVS and AACE Pharmaceuticals Inc. with expiration dates ranging from February 2024 to September 2025. The products are being recalled due to lack of sterility assurance at the facility noted during an inspection conducted by the Food and Drug Administration (FDA).

Risk Statement: For those patients who use these products, there is a potential risk of eye infections or related harm. These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. To date, Brassica Pharma Pvt. Ltd. has not received any reports of adverse events up to 16th February 2024 related to this recall.

Mumbai, Maharashtra) Kilitch Healthcare India Limited is issuing an amendment in the last Nationwide press release dated November 13, 2023 issued for nationwide recall of various eye drops. There are corrections in product NDC No for the below mentioned products.

Product Product Info Incorrect NDC # Correct NDC # Retailer/Label
LUBRICANT GEL DROPS 15 ML Carboxymethylcellulose Sodium Eye Drops 1.0% W/V 11822-9706-5 11822-4540-5 Rite Aid
LUBRICANT EYE DROPS 15ML (TWIN PACK) Carboxymethylcellulose Sodium Eye Drops 0.5% W/V 11822-9707-5 11822-4811-5 Rite Aid

Leiters Health is voluntarily recalling 33 lots of products listed below to the user level. The recalled batches of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags are being recalled due to the potential for superpotency because they may contain twice the labeled amount of drug. The semi-automated IV bag filling equipment used to fill the recalled batches may not eject the IV bags properly when compressed air tanks become low or a leak was detected, causing the recalled IV bags to be dosed twice.

Risk Statement: There is a reasonable probability that the use of the defective vancomycin and fentanyl IV bags will be associated with life-threatening adverse events. Administration of vancomycin at twice the infusion rate has been associated with low blood pressure, including shock and cardiac arrest, as well as wheezing, shortness of breath, hives, itchy skin and skin redness. Also, overdosing of vancomycin may be associated with acute kidney injury and ototoxicity. Administration of higher doses of fentanyl than intended can result in profound respiratory depression, which may not automatically be mitigated and treated, resulting in potential for delay in care and serious adverse outcomes from hypoxia, including permanent neurologic sequelae and death. In addition to respiratory depression, fentanyl can cause serious cardiac adverse events, such as hypotension, bradycardia, and vasodilation resulting in decrease in cardiac output and cardiac arrest. In addition, administration of a higher dose of phenylephrine than intended may cause higher-than-intended blood pressures in some patients.

Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (“Insight”), is voluntarily recalling one lot of Americaine® 20% Benzocaine Topical Anesthetic Spray to the consumer level. While benzene is not an ingredient in any Americaine® 20% Benzocaine Topical Anesthetic Spray products, a recent review by our manufacturer and their third-party lab found that a sample from one lot of the product showed a low level of benzene came from the propellant that sprays the product out of the can. Importantly, no other lots of Americaine® 20% Benzocaine Topical Anesthetic Spray (either before or after this batch code) are in the scope of this recall and may continue to be used by consumers safely and as intended.

Risk Statement: Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally, and through the skin and it potentially can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life threatening. Insight is recalling these products out of an abundance of caution. To date, the Company has not received any serious adverse events related to this recall. Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources.

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Bleomycin for Injection, USP 15 units Single Dose ONCO-TAIN™ Glass Fliptop Vial, lot BL12206A, to the user level. The recall was initiated due to a confirmed customer report for the presence of glass particulate within a single vial.

Should a patient receive injectable product containing glass particulate matter as a result of this issue, the patient may experience adverse events including injection site reaction, localized vein inflammation or phlebitis, thrombus, embolus and/or end-organ granuloma or life-threatening blood clot events. The risk is reduced by the possibility of detection, as the label contains a statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration.

Leiters Health is voluntarily recalling 33 lots of products listed below to the user level. The recalled batches of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags are being recalled due to the potential for superpotency because they may contain twice the labeled amount of drug. The semi-automated IV bag filling equipment used to fill the recalled batches may not eject the IV bags properly when compressed air tanks become low or a leak was detected, causing the recalled IV bags to be dosed twice.

Risk Statement: There is a reasonable probability that the use of the defective vancomycin and fentanyl IV bags will be associated with life-threatening adverse events. Administration of vancomycin at twice the infusion rate has been associated with low blood pressure, including shock and cardiac arrest, as well as wheezing, shortness of breath, hives, itchy skin and skin redness. Also, overdosing of vancomycin may be associated with acute kidney injury and ototoxicity. Administration of higher doses of fentanyl than intended can result in profound respiratory depression, which may not automatically be mitigated and treated, resulting in potential for delay in care and serious adverse outcomes from hypoxia, including permanent neurologic sequelae and death. In addition to respiratory depression, fentanyl can cause serious cardiac adverse events, such as hypotension, bradycardia, and vasodilation resulting in decrease in cardiac output and cardiac arrest. In addition, administration of a higher dose of phenylephrine than intended may cause higher-than-intended blood pressures in some patients.