FDA Drug Recalls

Recalls / Active ingredient / Simvastatin

Simvastatin

19 FDA drug recalls involving the active ingredient “Simvastatin.

DateClassProductFirm
2025-05-19Class IIIEzetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark PharmaceuticGlenmark Pharmaceuticals Inc., USA
2023-02-07Class IISimvastatin Tablets USP 20 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-005-15, UPC 3 16729 00515 9; Accord Healthcare, Inc.
2023-02-07Class IISimvastatin Tablets USP 5 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-156-15, UPC 3 16729 15615 8; bAccord Healthcare, Inc.
2023-02-07Class IISimvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-004-15, UPC 3 16729 00415 Accord Healthcare, Inc.
2023-02-07Class IISimvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15, UPC 3 16729 00615 6Accord Healthcare, Inc.
2023-02-07Class IISimvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3; Accord Healthcare, Inc.
2021-10-14Class IIEzetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. RedGolden State Medical Supply Inc.
2021-10-14Class IIEzetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured by Dr. Reddy's LaboraGolden State Medical Supply Inc.
2021-10-05Class IIDr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-30), b) 90 count (NDC 4Dr. Reddy's Laboratories, Inc.
2021-10-05Class IIDr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC 43598-742-90) and b) 1000 count (Dr. Reddy's Laboratories, Inc.
2021-10-05Class IIDr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-30), b) 90 count (NDC 4Dr. Reddy's Laboratories, Inc.
2021-10-05Class IIDr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Dr. Reddy's Laboratories, Inc.
2021-10-05Class IIDr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-30), b) 90 count (NDC 4Dr. Reddy's Laboratories, Inc.
2021-03-15Class IIEZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; RX; TABLETSCardinal Health Inc.
2020-03-18Class IISimvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJAurobindo Pharma USA Inc.
2019-07-29Class IIISimvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 0881Aurobindo Pharma USA Inc.
2017-12-22Class IIISimvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., PHetero Labs, Ltd. - Unit III
2014-12-04Class IIISimvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, InMicro Labs Usa, Inc S
2014-08-19Class IIISimvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, Micro Labs Usa, Inc S