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Major Pharmaceuticals Recalls
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Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC:...
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61
Gabapentin 100 mg Capsules Recalled by Major Pharmaceuticals in 2025, 100-Count Pack
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Major Pharmaceuticals Gabapentin 100 mg 10-Capsule Recall Nationwide 2025
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Major Pharmaceuticals Chlorpromazine 25 mg Tablets Recalled for Nitrosamine Contamination (1256 Bls,
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Major Pharmaceuticals Chlorpromazine Hydrochloride 50 mg Tablets Recalled for Nitrosamine Impurity (
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Major Pharmaceuticals Chlorpromazine Hydrochloride 200 mg Recall Involves 1,394 Blister Packs (2025)
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Major Pharmaceuticals Chlorpromazine Hydrochloride 100 mg Recall 2025 — 866 Blister Packs Nationwide
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Major Pharmaceuticals Chlorpromazine Hydrochloride 25 mg Tablets Recall 2025 for CGMP Deviations
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
High-Risk Antibiotic Recall: Sulfamethoxazole and Trimethoprim 800/160 mg Double Strength Packets Re
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Carvedilol Tablets 12.5 mg Recall Expanded for NNCI Impurity Above FDA Limit (2025)
The FDA recalls 26,628 cartons of Carvedilol Tablets USP 12.5 mg distributed nationwide. The product fails CGMP standards due to NNCI impurity exceeding FDA limits. Stop using and contact The Harvard Drug Group LLC and Rugby Laboratories for guidance.