Class II · Moderate risk
Alprostadil 32mcg/Ml 32mcg/Ml Injectable
Lack of assurance of sterility
FDA drug recalls in 2021
Every FDA drug recall initiated in 2021, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,152 recalls, newest first.
Class II · Moderate risk
Alprostadil 30mcg/Ml Inj 30mcg/Ml Injectable
Lack of assurance of sterility
Class II · Moderate risk
Alprostadil 25mcg/Ml 25mcg/Ml Injectable
Lack of assurance of sterility
Class II · Moderate risk
Alprostadil 22mcg/Ml 22mcg/Ml Injectable
Lack of assurance of sterility
Class II · Moderate risk
Alprostadil 22.5mcg/Ml 22.5mcg/Ml Injectable
Lack of assurance of sterility
Class II · Moderate risk
(well's Lipo-Lean)inositol/Choline/B-Comp+leucine+carn+…
Lack of assurance of sterility
Class II · Moderate risk
Estradiol Valerate 20 mg/mL in Ethyl Oleate Inj. 20 mg/mL Injection in vials
Lack of assurance of sterility
Class I · High risk
Methocarbamol 500mg Tablet
Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
Class II · Moderate risk
Irbesartan and Hydrochlorothiazide Tablets USP
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk
Irbesartan and Hydrochlorothiazide Tablets USP
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk
Irbesartan Tablets USP
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk
Irbesartan Tablets USP
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class II · Moderate risk
Irbesartan Tablets USP
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Class III · Low risk
AllerClear D-24 hr
Failed Moisture Limits
Class III · Low risk
Loratadine-D Extended-Release Tablets
Failed Moisture Limits
Class II · Moderate risk
Imipramine Pamoate Capsules 125 mg
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Class III · Low risk
Cetirizine hydrochloride
Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.
Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk
Omeprazole Delayed-Release Capsules
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Class II · Moderate risk
Betaxolol Ophthalmic Solution
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Class II · Moderate risk
Lotrimin Af
cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.