US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
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 II · Moderate risk Terminated

Micardis Tablets

Reason Subpotent Drug

Boehringer Ingelheim Pharmaceuticals, Inc. NDC 0597-0041-37 D-0600-2021
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 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 II · Moderate risk Terminated

Sodium Chloride 0.9%

Reason Temperature Abuse: Product exposed to temperature outside specified limits.

Fresenius Medical Care Holdings, Inc. NDC 46163-0300-10 D-0603-2021
Class II · Moderate risk Terminated

Haloperidol Decanoate Injection

Reason Lack of Assurance of Sterility

Teva Pharmaceuticals USA NDC 0703-7131-03 D-0378-2021
Class II · Moderate risk Terminated

Metoclopramide Injection USP

Reason Lack of Assurance of Sterility

Teva Pharmaceuticals USA NDC 0703-4502-04 D-0377-2021
Class II · Moderate risk Terminated

Haloperidol Decanoate Injection

Reason Lack of Assurance of Sterility

Teva Pharmaceuticals USA NDC 00703-7121-03 D-0375-2021
Class II · Moderate risk Terminated

Leucovorin Calcium for Injection

Reason Lack of Assurance of Sterility

Teva Pharmaceuticals USA NDC 0703-5145-01 D-0374-2021
Class II · Moderate risk Terminated

Estradiol Transdermal System Delivers 0.0375 mg/day

Reason Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.

Noven Pharmaceuticals Inc NDC 68968-3437-8 D-0337-2021
Class II · Moderate risk Terminated

Minivelle

Reason Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.

Noven Pharmaceuticals Inc NDC 68968-6675-8 D-0336-2021
Class II · Moderate risk Terminated

Oxygen

Reason cGMP deviations

Grace Healthcare Medical, Inc D-0355-2021
Class II · Moderate risk Terminated

Betadine

Reason Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility

Edge Pharma, LLC D-0335-2021
Class II · Moderate risk Terminated

Itraconazole Capsules

Reason Failed Dissolution Specifications

Jubilant Cadista Pharmaceuticals, Inc. NDC 59746-282-30 D-0333-2021
Class II · Moderate risk Terminated

Riomet

Reason Microbial Contamination of Non-Sterile Product

Sun Pharmaceutical Industries INC NDC 10631-206-02 D-0334-2021
Class II · Moderate risk Terminated

Antiseptic Hand Cleaner

Reason CGMP Deviations

Spartan Chemical Co Inc D-0361-2021