US Drug Recall Register

FDA Drug Recalls

2,661 recalls, newest first

Class I · High risk Ongoing

Vy&Tea

Reason Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine.

Qikmoov LLC D-0749-2021
Class I · High risk Ongoing

Limar Hand Sanitizer

Reason Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.

Ardil Comercial S.R.L. D-0691-2021
Class II · Moderate risk Ongoing

QiYu Hand Sanitizer

Reason Subpotent

Hoyu(us) Logistics INC D-0643-2021
Class II · Moderate risk Ongoing

Chantix

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

Pfizer Inc. NDC 0069-0469-56 D-0701-2021
Class II · Moderate risk Ongoing

Chantix

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

Pfizer Inc. NDC 0069-0471-03 D-0700-2021
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-0699-2021
Class II · Moderate risk Ongoing

Daytrana

Reason Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.

Noven Pharmaceuticals Inc NDC 68968-5553-1 D-0394-2021
Class II · Moderate risk Ongoing

Daytrana

Reason Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.

Noven Pharmaceuticals Inc NDC 68968-5552-1 D-0393-2021
Class II · Moderate risk Ongoing

MEDICALLY MINDED Hand Sanitizer Gel

Reason CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

Global Sanitizers LLC D-0783-2021
Class II · Moderate risk Ongoing

MEDICALLY MINDED Hand Sanitizer Gel

Reason CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

Global Sanitizers LLC D-0782-2021
Class I · High risk Ongoing

MEDICALLY MINDED Hand Sanitizer Gel

Reason Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.

Global Sanitizers LLC D-0781-2021
Class I · High risk Ongoing

MEDICALLY MINDED Hand Sanitizer Gel

Reason Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim for ethanol content and to contain methanol.

Global Sanitizers LLC D-0780-2021
Class II · Moderate risk Ongoing

MEDICALLY MINDED Hand Sanitizer Gel

Reason CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

Global Sanitizers LLC D-0779-2021
Class II · Moderate risk Ongoing

MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera

Reason CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

Global Sanitizers LLC D-0778-2021
Class II · Moderate risk Ongoing

Imperia Elita Vitaccino Coffee

Reason Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine

Dash Xclusive D-0628-2021
Class II · Moderate risk Ongoing

Preferred Pharmaceuticals Inc.

Reason CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.

Preferred Pharmaceuticals, Inc. D-0385-2021