US Drug Recall Register

FDA Drug Recalls

14,450 recalls · Class II, newest first

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

All Over-The-Counter

Reason CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Also, due to unusually hot weather, FDA Recalled Products may have been subjected to temperatures in excess of storage condition instructions on product labeling.

Inmar Supply Chain Solutions, LLC D-1104-2023
Class II · Moderate risk Terminated

Capsaicin Cream 0.025%

Reason Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste

Avkare LLC NDC 50268-195-60 D-1147-2023
Class II · Moderate risk Terminated

Sodium Fluoride 1.1%

Reason Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste

Avkare LLC NDC 42291-741-51 D-1146-2023
Class II · Moderate risk Terminated

DIANEAL Low Calcium

Reason Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

Baxter Healthcare Corporation NDC 0941-0409-06 D-1140-2023
Class II · Moderate risk Terminated

hello wild strawberry fluoride toothpaste

Reason Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons labeled as hello wild strawberry fluoride toothpaste were incorrectly filled in tubes labeled as hello fresh watermelon fluoride free toothpaste.

Colgate Palmolive Company D-1084-2023
Class II · Moderate risk Completed

Lugol's

Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.

Ecometics, Inc. NDC 59365-6064-0 D-1102-2023
Class II · Moderate risk Completed

AstrinGyn

Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.

Ecometics, Inc. NDC 59365-6065-0 D-1101-2023
Class II · Moderate risk Completed

activator concentrate

Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.

Ecometics, Inc. D-1100-2023
Class II · Moderate risk Completed

Unguentine Ointment

Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.

Ecometics, Inc. D-1099-2023
Class II · Moderate risk Completed

Alcolado Relampago

Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.

Ecometics, Inc. D-1098-2023
Class II · Moderate risk Completed

Yager's Liniment

Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.

Ecometics, Inc. D-1097-2023
Class II · Moderate risk Completed

Blis-To-Sol Liquid

Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.

Ecometics, Inc. D-1096-2023
Class II · Moderate risk Terminated

Rasagiline Tablets 0.5mg

Reason Failed dissolution specifications - results obtained were below spec average.

Aurobindo Pharma USA Inc. NDC 0378-1270-93 D-1171-2023
Class II · Moderate risk Terminated

Helix CBD Clinical Cream

Reason CGMP Deviations

Parker Laboratories, Inc. NDC 30775-054-01 D-1093-2023
Class II · Moderate risk Terminated

Helix CBD Therapy Cream

Reason CGMP Deviations

Parker Laboratories, Inc. NDC 30775-053-01 D-1092-2023
Class II · Moderate risk Terminated

Helix Tri-Active Therapy Cream

Reason CGMP Deviations

Parker Laboratories, Inc. NDC 30775-052-03 D-1091-2023
Class II · Moderate risk Terminated

Helix Pain Relieving Cream

Reason CGMP Deviations

Parker Laboratories, Inc. NDC 30775-051-01 D-1090-2023
Class II · Moderate risk Terminated

Protex Foaming Hand Sanitizer

Reason CGMP Deviations

Parker Laboratories, Inc. NDC 30775-040-02 D-1089-2023
Class II · Moderate risk Terminated

Rufinamide Tablets

Reason cGMP deviations: Batch was released prior to approval.

Aurobindo Pharma USA Inc. NDC 59651-617-08 D-1088-2023
Class II · Moderate risk Terminated

Rufinamide Tablets

Reason cGMP deviations: Batch was released prior to approval.

Aurobindo Pharma USA Inc. NDC 59651-616-08 D-1087-2023
Class II · Moderate risk Completed

Cromolyn Sodium Oral Solution

Reason CGMP deviation: product released prior to supplier approval.

The Ritedose Corporation NDC 76204-025-96 D-0946-2023
Class II · Moderate risk Terminated

morphine in 0.9% Sodium Chloride

Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services Inc D-1080-2023
Class II · Moderate risk Terminated

fentaNYL in 0.9% sodium chloride

Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services Inc D-1079-2023