FDASeptember 17, 2013drug
Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-count tablets per dosage card in a carton, NDC 51079-450-63, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
What to do
FDA enforcement status: Terminated
Brands named
mylan institutional inc d b a udl laboratoriesmylanmylan institutional
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAMinocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-644-302026-06-01
- CPSCMissry Associates Recalls Misco Sports Light-Up Racket Sets Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys2026-05-28
- CPSCMiniWarGaming and Primal Horizon Disc Magnets Recalled Due to Risk of Serious Injury or Death from Ingestion; Violate Mandatory Standard for Magnets; Imported by MiniWarGaming2026-05-28
- FDAMedtronic O-arm O2 Imaging System. Model Number: BI70002000.2026-05-19
- FDADRAGONFLY Thai Ginger Powder Net Weight: 4.37 oz (125 g) PRODUCT OF THAILAND Packed for: U.S. Trading Company Hayward, CA 94545-1130 UPC: 7215575335672026-05-15
- CPSCMissry Associates Recalls Misco Sports Badminton Toy Sets Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys2026-05-14
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