US Drug Recall Register

FDA Drug Recalls

14,801 recalls, newest first

Class II · Moderate risk Terminated

Advance Hand Sanitizer

Reason CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.

Dibar Nutricional S De Rl De Cv D-0647-2021
Class II · Moderate risk Terminated

ProtectoRx

Reason CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.

Dibar Nutricional S De Rl De Cv NDC 75408-002-01 D-0646-2021
Class II · Moderate risk Terminated

DiBAR LABS Hand Sanitizer

Reason CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.

Dibar Nutricional S De Rl De Cv NDC 73009-001-16 D-0645-2021
Class I · High risk Terminated

DiBAR LABS Hand Sanitizer

Reason Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol.

Dibar Nutricional S De Rl De Cv NDC 73009-0001-08 D-0644-2021
Class III · Low risk Terminated

Cequa

Reason Subpotent and Presence of Particulates .

Sun Pharmaceutical Industries INC NDC 47335-506-96 D-0391-2021
Class II · Moderate risk Terminated

Micardis Tablets

Reason Subpotent Drug

Boehringer Ingelheim Pharmaceuticals, Inc. NDC 0597-0041-37 D-0600-2021
Class III · Low risk Terminated

Atorvastatin Calcium Tablets

Reason Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities

Dr. Reddy's Laboratories, Inc. NDC 55111-121-05 D-0599-2021
Class II · Moderate risk Terminated

Metformin HCl Extended-Release Tablets

Reason Presence of foreign substance: identified as activated carbon.

Sun Pharmaceutical Industries INC NDC 62756-142-02 D-0372-2021
Class I · High risk Terminated

1% Lidocaine HCl Injection

Reason Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP

Pfizer, INC NDC 0409-4279-16 D-0627-2021
Class I · High risk Terminated

0.5% Bupivacaine Hydrochloride Injection

Reason Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP

Pfizer, INC NDC 0409-1162-19 D-0626-2021
Class III · Low risk Terminated

Thiamine HCl Injection

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.

Mylan Institutional LLC D-0601-2021
Class II · Moderate risk Terminated

Sterile Water for Inj.

Reason Presence of Particulate Matter: particulate matter identified as an insect in one vial.

Pfizer Inc. D-0384-2021
Class I · High risk Terminated

NP Thyroid 120 Thyroid Tablets

Reason Subpotent Drug

Acella Pharmaceuticals, LLC NDC 42192-328-01 D-0399-2021
Class I · High risk Terminated

NP Thyroid 90 Thyroid Tablets

Reason Subpotent Drug

Acella Pharmaceuticals, LLC NDC 42192-331-01 D-0398-2021
Class I · High risk Terminated

NP Thyroid 60 Thyroid Tablets

Reason Subpotent Drug

Acella Pharmaceuticals, LLC NDC 42192-330-01 D-0397-2021
Class I · High risk Terminated

NP Thyroid 30 Thyroid Tablets

Reason Subpotent Drug

Acella Pharmaceuticals, LLC NDC 42192-329-01 D-0396-2021
Class I · High risk Terminated

NP Thyroid 15 Thyroid Tablets

Reason Subpotent Drug

Acella Pharmaceuticals, LLC NDC 42192-327-01 D-0395-2021
Class III · Low risk Terminated

Olmesartan Medoxomil Tablets

Reason Presence of Foreign Tablet/Capsule

Ascend Laboratories LLC NDC 67877-446-30 D-0392-2021