US Drug Recall Register

FDA Drug Recalls

17,898 recalls, newest first

Class III · Low risk Terminated

Higher Education Make Out Ready Vegan Lip Balm

Reason Mislabeling: The active ingredient list on the label does not match the product's actual ingredients Specifically, the label states Octinoxate 7.5% and Oxybenzone 3%, while the product therein is made with Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%, and Avobenzone 3%.

Eco Lips, Inc D-0890-2022
Class III · Low risk Terminated

buPROPion Hydrochloride Extended-Release Tablet

Reason Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.

Sun Pharmaceutical Industries INC NDC 47335-738-86 D-0858-2022
Class III · Low risk Terminated

buPROPion Hydrochloride Extended-Release Tablet

Reason Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.

Sun Pharmaceutical Industries INC D-0857-2022
Class II · Moderate risk Terminated

Xanax XR

Reason Failed Dissolution Specifications: low out of specification results for dissolution.

Viatris Inc NDC 0009-0068-07 D-0854-2022
Class II · Moderate risk Terminated

alprazolam XR extended-release tablets

Reason Failed Dissolution Specifications: low out-of-specification dissolution test results observed.

Viatris Inc NDC 59762-0068-1 D-0844-2022
Class II · Moderate risk Terminated

GaviLyte -C

Reason Failed Stability Specification

Lupin Pharmaceuticals Inc. NDC 43386-060-19 D-0875-2022
Class II · Moderate risk Completed

Zonisamide Capsules

Reason cGMP deviations

Glenmark Pharmaceuticals Inc., USA NDC 68462-130-01 D-0793-2022
Class II · Moderate risk Completed

Zonisamide Capsules

Reason cGMP deviations

Glenmark Pharmaceuticals Inc., USA NDC 68462-129-01 D-0792-2022
Class II · Moderate risk Completed

Zonisamide Capsules USP

Reason cGMP deviations

Glenmark Pharmaceuticals Inc., USA NDC 68462-128-01 D-0791-2022
Class II · Moderate risk Terminated

Accupril

Reason CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.

Pfizer Inc. NDC 0071-0535-23 D-0874-2022
Class II · Moderate risk Terminated

Accupril

Reason CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.

Pfizer Inc. NDC 0071-0532-23 D-0873-2022
Class II · Moderate risk Terminated

Accupril

Reason CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.

Pfizer Inc. NDC 0071-0530-23 D-0872-2022
Class II · Moderate risk Ongoing

Erythromycin Topical Gel USP

Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

McKesson Corporation dba McKesson Drug Company NDC 63739-053-68 D-0851-2022
Class II · Moderate risk Ongoing

Betamethasone Dipropionate Ointment USP

Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

McKesson Corporation dba McKesson Drug Company NDC 63739-996-65 D-0850-2022
Class II · Moderate risk Ongoing

Lidocaine Prilocaine Cream USP

Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

McKesson Corporation dba McKesson Drug Company NDC 63739-054-66 D-0849-2022
Class II · Moderate risk Ongoing

Lidocaine Hydrochloride Topical Solution USP 4%

Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

McKesson Corporation dba McKesson Drug Company NDC 63739-977-64 D-0848-2022
Class II · Moderate risk Ongoing

Halobetasol Propionate Ointment 0.05% Net Wt.

Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

McKesson Corporation dba McKesson Drug Company NDC 63739-998-67 D-0847-2022
Class II · Moderate risk Terminated

Torco Racing Fuels Hand Sanitizer

Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

Torco Race Fuels D-0786-2022
Class I · High risk Terminated

Tacrolimus

Reason Subpotent drug

Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy D-1168-2022
Class I · High risk Terminated

Tacrolimus

Reason Subpotent drug

Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy D-1167-2022