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Statins

FDA recalls

30 rows

DateCompany and reasonClass
Dec 30, 2025Avkare
Out of specification for dissolution.		Class II · Ongoing
Sep 18, 2025Ascend Laboratories, LLC
Failed Dissolution Specifications		Class II · Ongoing
Mar 16, 2025Biocon Pharma Inc
Failed dissolution specifications: lower than specifications		Class II · Ongoing
Mar 12, 2025Glenmark Pharmaceuticals Inc., USA
CGMP Deviations		Class II · Ongoing
Mar 12, 2025Glenmark Pharmaceuticals Inc., USA
CGMP Deviations		Class II · Ongoing
Jun 27, 2024Glenmark Pharmaceuticals Inc., USA
Failed Dissolution Specifications: results below specifications		Class II · Ongoing
Mar 15, 2023Northwind Pharmaceuticals LLC
CGMP Deviations		Class II · Ongoing
Feb 6, 2023Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.		Class II · Terminated
Feb 6, 2023Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.		Class II · Terminated
Feb 6, 2023Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.		Class II · Terminated
Feb 6, 2023Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.		Class II · Terminated
Mar 15, 2022Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications: Out of Specification results for related substance.		Class III · Terminated
Jun 3, 2021Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities		Class III · Terminated
May 3, 2021Dr. Reddy's Laboratories, Inc.
Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities		Class III · Terminated
Feb 18, 2021Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities		Class III · Terminated
Mar 17, 2020Aurobindo Pharma USA Inc.
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed		Class II · Terminated
Oct 21, 2019Apotex Inc.
Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.		Class III · Terminated
Jul 28, 2019Aurobindo Pharma USA Inc.
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B		Class III · Terminated
Mar 24, 2019Glenmark Pharmaceuticals Inc., USA
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.		Class II · Terminated
Feb 12, 2019Lupin Pharmaceuticals Inc.
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.		Class III · Terminated
Aug 1, 2018Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.		Class III · Terminated
Jun 11, 2018Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications		Class III · Terminated
May 29, 2018Dr. Reddy's Laboratories, Inc.
Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.		Class II · Terminated
Jan 28, 2018Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability		Class III · Terminated
Dec 21, 2017Hetero Labs, Ltd. - Unit III
Presence of foreign substance: metallic razor blade was found in one bottle.		Class III · Terminated
Nov 16, 2017Lupin Limited
Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle.		Class II · Terminated
Jul 10, 2017Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.		Class III · Terminated
Mar 20, 2017Mylan Institutional, Inc. (d.b.a. Udl Laboratories)
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.		Class II · Terminated
Mar 19, 2017Mylan Pharmaceuticals Inc.
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.		Class II · Terminated
Apr 4, 2013Glenmark Generics Inc., USA
Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.		Class III · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).