FDA drug recalls

IntegraDose Compounding Services LLC is recalling Vasopressin 2 Units/2 mL syringes because the drug may contain less active ingredient than labeled. This affects two specific lots distributed nationwide. No injuries have been reported.

VistaPharm's Kerr Insta-Char activated charcoal product did not meet the required Over-the-Counter (OTC) Monograph standards set by the FDA. The affected product is a 240 mL bottle containing 50 grams of activated charcoal in a sorbitol base with cherry flavor (Lot #AH001, expiring 8/31/2026).

VistaPharm's Kerr Insta-Char activated charcoal suspension did not meet the standards required for over-the-counter products. The product was distributed nationwide, and affected lots should not be used.

VistaPharm's Kerr Insta-Char activated charcoal product did not meet the required OTC Monograph M023 standards set by the FDA. The affected product is a 240 ml bottle containing 50 grams of activated charcoal with cherry flavor (Lot #AE001, expiring 5/31/2026) distributed nationwide.

VistaPharm's Kerr Insta-Char activated charcoal product failed to meet required Over-the-Counter (OTC) monograph standards. The product may not perform as intended or meet quality requirements for safety and effectiveness.

Glenmark Pharmaceuticals is recalling specific lots of Alyacen 7/7/7 (a birth control pill) because testing found higher-than-allowed impurity levels in the tablets. The affected lots were distributed nationwide. No injuries have been reported.

Sun Pharmaceutical has recalled budesonide inhalation suspension (1mg/2mL single-dose ampules) due to the presence of black or brown specs and particles found in some vials. The affected lot is BAG0074A with an expiration date of January 31, 2027. This is a quality issue that could affect the safety and sterility of the medication.

Ascend Laboratories is recalling Minocycline Hydrochloride Extended-Release Tablets, 115 mg (lot 25141635, expires 4/30/2028) because testing found the tablets did not dissolve properly as required. This affects 360 bottles distributed nationwide. No injuries have been reported.

Gas-X Extra Strength softgels were contaminated with a diluted propylene glycol-based coolant during packaging due to a machine leak. The contamination affected specific lot numbers distributed nationwide. No injuries have been reported.

Golden State Medical Supply is recalling specific lots of niacin extended-release tablets (1,000 mg) because they failed to dissolve properly during stability testing. The tablets did not meet dissolution specifications at the 24-hour mark, which means they may not release the medication as intended in the body.

Zep Inc. is recalling Alcohol Sanitizer Spray (Ethanol 70%, 55-gallon drums) due to microbial contamination. The affected batch (E2612116, expiration April 2029) was distributed nationwide. A total of 5 drums are involved.

Amneal Pharmaceuticals is recalling Primidone 50 mg tablets (NDC 53746-544-01, lot AM251676) due to potential cross-contamination with Acemetacin during manufacturing at the API supplier. The contamination could affect the safety or effectiveness of the medication.

Breckenridge Pharmaceutical is recalling specific lots of Duloxetine Delayed-Release Capsules 60mg due to higher-than-acceptable levels of a chemical impurity called N-nitroso-duloxetine. This impurity was found during manufacturing quality checks. The recall affects about 360,000 bottles distributed nationwide.

Breckenridge Pharmaceutical is recalling one lot of Duloxetine Delayed-Release Capsules 30mg due to the presence of N-nitroso-duloxetine impurity above FDA's recommended interim limit. This is a manufacturing quality issue. No injuries have been reported.

Fresenius Kabi USA is recalling specific batches of epinephrine injection due to failed impurity and degradation specifications. The affected vials may not meet required purity standards. No injuries have been reported.

Sun Pharmaceutical's doxorubicin hydrochloride liposome injection vials were found to contain glass particles. The affected vials are lot HAG2581B, which expire in May 2027. About 675 vials were distributed nationwide.

Beekeeper's Naturals Saline Nasal Spray was manufactured without proper sterilization, allowing microbial contamination. The affected product is Lot #5950 with an expiration date of 02/2028. No injuries have been reported so far.

AbbVie is recalling specific lots of PRED MILD (prednisolone acetate) eye drops because they failed stability testing. The affected product may not maintain its intended strength or safety over time. Two lots are involved, with an expiration date of August 2026.

AVEVA nicotine patches (14 mg) distributed by Rugby Laboratories have elevated levels of chemical impurities that exceed safety standards for shelf life. The issue was discovered during stability testing of specific lots. No injuries have been reported.

Wisconsin Pharmacal Company's MG217 Multi-Symptom Treatment Cream (colloidal oatmeal 2%, 6 oz) has been found to contain Staphylococcus aureus bacteria. The contamination was confirmed in lot #1024088 (expiration 11/30/2026). About 690 tubes were distributed nationwide and to the Bahamas.

Safecor Health's Nephronex vitamin B-complex, vitamin C, and folic acid oral liquid supplement was found to contain black particles in the liquid. The affected product is supplied in 5 mL oral syringes. The contamination was identified in three specific lots distributed in Ohio.

IntegraDose Compounding Services LLC has recalled fentanyl citrate sterile injection (2,250 mcg/50 mL) because the drug may contain less active ingredient than labeled. This lot was distributed nationwide to healthcare facilities.

UCB Biosciences is recalling specific lots of Cimzia (certolizumab pegol) 200 mg prefilled syringes because the manufacturer cannot confirm the product remained sterile during production. This is a precautionary recall; no infections or injuries have been reported so far.

Zydus Pharmaceuticals is recalling erythromycin 500 mg tablets because testing found a chemical impurity (N-Nitroso-Desmethyl-Erythromycin) at levels higher than FDA's recommended safe intake limit. The impurity resulted from manufacturing process deviations at the maker in India. No injuries have been reported.

Zydus Pharmaceuticals is recalling erythromycin tablets (250 mg) due to the presence of N-Nitroso-Desmethyl-Erythromycin, a nitrosamine impurity, at levels above the FDA's acceptable intake limit. The affected bottles were distributed nationwide. This impurity can potentially increase cancer risk with long-term exposure.

ANI Pharmaceuticals is recalling estradiol gel (0.1%, 0.25 mg packets) because some packets in affected cartons were found to be empty or only partially filled. This could mean patients receive less medication than prescribed. The recall affects carton lot M251109, which expires in November 2027.

Gas-X Simethicone 125 mg softgels distributed by Haleon are being recalled because the carton labeling does not list all inactive ingredients. This affects three specific lot codes (KB5Y, MP4B, and SS4F) distributed nationwide.

Lupin Pharmaceuticals is recalling certain batches of Liraglutide Injection (a diabetes and weight-loss medication) because white thread-like particles have been found inside the cartridges. The affected pens are distributed nationwide. No injuries have been reported.

Sagent Pharmaceuticals is recalling two lots of Busulfan Injection due to failed impurities and degradation specifications. The affected lots are 656412 (expiring 08/31/2026) and 659646 (expiring 03/31/2027). This is a prescription medication used in cancer treatment.

Safecor Health distributed atomoxetine 25 mg capsules that were labeled as 10 mg capsules. This labeling error affects one lot distributed in Texas. The mislabeling could result in patients taking a higher dose than prescribed.