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FDA recalls of prescription and over-the-counter drugs.
Crestline Pharmaceuticals is recalling two lots of warfarin sodium tablets after a labeling error swapped 2.5 mg and 5 mg strengths.
Wellnov Supplements LLC is recalling Liposomal B12 Spray due to deviations from good manufacturing practices that could allow bacterial pathogens and Clostridium botulinum to contaminate the product.
Zydus Pharmaceuticals is recalling erythromycin 500 mg tablets nationwide due to the presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit, resulting from manufacturing deviations.
Wellnov Supplements LLC is recalling Liposomal Sleep Spray (30 ml aluminum bottles, lot SL0925) distributed nationwide due to manufacturing deviations that could allow bacterial pathogens and C. botulinum contamination.
Wellnov Supplements LLC is recalling Liposomal Kids Liquid Multivitamin Drops due to manufacturing deviations that could allow bacterial pathogens and Clostridium botulinum to contaminate the product. The recalled product was distributed nationwide and in Puerto Rico.
Safecor Health, LLC is recalling Atomoxetine HCl 10 mg capsules because some units are incorrectly labeled as 10 mg when they actually contain 25 mg. Patients taking the mislabeled product may receive an incorrect dose.
Wellnov Supplements LLC is recalling Liposomal Collagen Booster due to deviations from Good Manufacturing Practices that could allow bacterial pathogens and possibly Clostridium botulinum to contaminate the product.
UCB Biosciences is recalling CIMZIA (certolizumab pegol) prefilled syringes nationwide because of a lack of assurance of sterility. Affected lots are distributed across the US.
Wisconsin Pharmacal Company is recalling MG217 Multi-Symptom Treatment Cream & Skin Protectant due to confirmed presence of Staphylococcus aureus contamination. Affected units are 6 oz tubes with Lot #1024088, expiring 11/30/2026, distributed nationwide and in the Bahamas.
Zydus Pharmaceuticals is recalling Erythromycin Tablets, 250 mg, nationwide because certain lots contain N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit due to CGMP deviations.
Wellnov Supplements LLC is recalling Liposomal Women's Liquid Multivitamin Drops - Iron Free due to deviations from good manufacturing practices that could lead to bacterial pathogen and possible Clostridium botulinum contamination.
Lupin Pharmaceuticals is recalling Liraglutide Injection due to the presence of white thread-like structures (particulate matter) found in cartridges. The recall affects 217,621 pen injectors distributed nationwide.
ANI Pharmaceuticals is recalling Estradiol Gel 0.1% (Lot M251109) distributed nationwide because some packets were found to be either empty or partially full.
IntegraDose Compounding Services LLC is recalling fentanyl citrate sterile injection (2,500 mcg/50mL) distributed nationwide due to subpotent drug content. The voluntary recall affects 376 cassettes with lot number 20260310FEN-1, expiration date 09/06/2026.
Golden State Medical Supply Inc. is recalling Primidone 50 mg tablets due to cross-contamination of the active pharmaceutical ingredient with trace amounts of Acemetacin API. The recall affects 8,526 bottles distributed nationwide.
Haleon is recalling Gas-X Simethicone 125 mg softgels due to incomplete inactive ingredient information on carton labeling.
Safecor Health is recalling a vitamin and mineral dietary supplement oral liquid due to the presence of black particles in the liquid. Affected lots were distributed in Ohio.
Llorens Pharmaceuticals is recalling Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement due to black particulate matter contamination. The product was distributed across multiple US states and Puerto Rico.
Lannett Company Inc. is recalling Primidone 250mg tablets nationwide due to cross-contamination with trace amounts of Acemetacin in the active pharmaceutical ingredient. The recall affects 44,865 bottles distributed across the USA.
Sagent Pharmaceuticals is recalling two lots of Busulfan Injection due to failed impurities and degradation specifications. The affected lots were distributed nationwide.
Amerisource Health Services LLC is recalling Primidone 250 mg tablets (Lot 1027583, expiration 09/30/2027) due to cross-contamination with trace amounts of Acemetacin API during manufacturing.
Golden State Medical Supply Inc. is recalling Primidone 250 mg tablets due to cross-contamination with trace amounts of Acemetacin API. The affected lots are distributed nationwide.
Amerisource Health Services LLC is recalling Primidone Tablets 50 mg due to cross-contamination of the active ingredient with trace amounts of Acemetacin API. The recall affects 225,000 tablets distributed nationwide.
Oasis Medical, Inc. is recalling Oasis Tears PF preservative-free lubricant eye drops nationwide due to lack of assurance of sterility following FDA observations during an inspection.
Endo USA, Inc. is recalling Buprenorphine Hydrochloride injection vials distributed nationwide due to the presence of particulate matter identified as Buprenorphine free base. The FDA classified this as a Class II recall.
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