US Drug Recall Register

FDA Drug Recalls

2,661 recalls, newest first

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

The Natural Dentist Healthy Balance Peppermint Sage

Reason Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8

Revive Personal Products Company D-0364-2022
Class III · Low risk Ongoing

Butalbital

Reason Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals D-0257-2022
Class III · Low risk Ongoing

Butalbital

Reason Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals D-0256-2022
Class II · Moderate risk Ongoing

Meclizine HCl Tablets

Reason Labeling: Incorrect Instructions

Rising Pharmaceuticals NDC 16571-752-01 D-0005-2022
Class II · Moderate risk Ongoing

Chantix

Reason CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Pfizer Inc. NDC 0069-0469-03 D-0811-2021
Class II · Moderate risk Ongoing

Chantix

Reason CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Pfizer Inc. NDC 0069-0469-56 D-0810-2021
Class II · Moderate risk Ongoing

Chantix

Reason CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Pfizer Inc. NDC 0069-0468-56 D-0809-2021
Class II · Moderate risk Ongoing

Chantix

Reason CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit

Pfizer Inc. NDC 00069-0471-03 D-0808-2021
Class II · Moderate risk Ongoing

Combipatch

Reason Failed Stability Specifications; out of specification for shear.

Noven Pharmaceuticals Inc NDC 68968-0525-2 D-0725-2021
Class II · Moderate risk Ongoing

Combipatch

Reason Failed Stability Specifications; out of specification for shear.

Noven Pharmaceuticals Inc NDC 68968-0514-2 D-0724-2021
Class II · Moderate risk Ongoing

Erythromycin Topical Solution USP

Reason Defective container: possibility for lack of seal integrity.

Teligent Pharma, Inc. NDC 52565-027-59 D-0769-2021
Class II · Moderate risk Ongoing

Miss Slim

Reason Marketed without ANDA/NDA approval

His Enterprise INC D-0770-2021
Class I · High risk Ongoing

ALPHA MALE+ Male Enhancer

Reason Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil

Alpha-Tek LLC D-0001-2022