US Drug Recall Register

FDA Drug Recalls

14,450 recalls · Class II, newest first

Class II · Moderate risk Terminated

Prevantics

Reason cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.

Professional Disposables International, Inc. NDC 10819-1080-1 D-0571-2022
Class II · Moderate risk Terminated

Prevantics

Reason cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.

Professional Disposables International, Inc. NDC 10819-4076-4 D-0570-2022
Class II · Moderate risk Ongoing

Premium Nature Instant Hand Sanitizer

Reason Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.

AMS Packaging Inc D-0647-2022
Class II · Moderate risk Ongoing

Premium Nature Instant Hand Sanitizer

Reason Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.

AMS Packaging Inc D-0646-2022
Class II · Moderate risk Terminated

Cystex Tablet

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. D-0555-2022
Class II · Moderate risk Terminated

DBI Magnums Tablet

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-941-00 D-0554-2022
Class II · Moderate risk Terminated

Coated Back Relief Tablet

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-800-00 D-0553-2022
Class II · Moderate risk Terminated

Legatrin

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-785-00 D-0552-2022
Class II · Moderate risk Terminated

Back Relief II

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-740-00 D-0551-2022
Class II · Moderate risk Terminated

Pain Aid PMF Caplet

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-710-00 D-0550-2022
Class II · Moderate risk Terminated

Normed Fem Tablet

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-701-00 D-0549-2022
Class II · Moderate risk Terminated

APAP 325 mg

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-700-00 D-0548-2022
Class II · Moderate risk Terminated

Migrenol Caplet

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-565-00 D-0547-2022
Class II · Moderate risk Terminated

Phenylephrine HCl 5 mg Tablet

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-333-00 D-0545-2022
Class II · Moderate risk Terminated

Nutralox Peppermint Antacid

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-312-00 D-0543-2022
Class II · Moderate risk Terminated

Spearmint Antacid Tablet

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-311-00 D-0542-2022
Class II · Moderate risk Terminated

Trial Antacid Tablet

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-310-00 D-0541-2022
Class II · Moderate risk Terminated

Cherry Antacid Tablet

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-304-00 D-0540-2022
Class II · Moderate risk Terminated

Peppermint Antacid tablet

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-303-00 D-0539-2022
Class II · Moderate risk Terminated

HPC Tablet

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62969-242-00 D-0538-2022
Class II · Moderate risk Terminated

APAP 500 mg SRC Coated

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-211-00 D-0537-2022
Class II · Moderate risk Terminated

APAP 500 mg tablet

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-210-00 D-0536-2022
Class II · Moderate risk Terminated

Extra-Strength Unaspirin caplet

Reason CGMP Deviations

ULTRAtab Laboratories, Inc. NDC 62959-207-00 D-0535-2022