US Drug Recall Register

FDA Drug Recalls

17,898 recalls, newest first

Class I · High risk Completed

Goodness Gurus

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1460-2020
Class I · High risk Completed

BC Hemp Co.

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1459-2020
Class I · High risk Completed

BC Hemp Co.

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1458-2020
Class I · High risk Completed

BC Hemp Co.

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1457-2020
Class I · High risk Completed

A Clean Choice CBD

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1456-2020
Class I · High risk Completed

A Clean Choice CBD

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1455-2020
Class I · High risk Completed

A Clean Choice CBD

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1454-2020
Class I · High risk Completed

Made by Hemp 1000MG Hemp Extract

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1453-2020
Class I · High risk Completed

Made by Hemp 1000MG Hemp Extract

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1452-2020
Class I · High risk Completed

Made by Hemp 1000MG Hemp Extract

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1451-2020
Class I · High risk Completed

Tasty Drops Hemp Oil Extract

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1450-2020
Class I · High risk Completed

Tasty Drops Hemp Oil Extract

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1449-2020
Class I · High risk Completed

Tasty Drops Hemp Oil Extract

Reason Chemical contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1448-2020
Class I · High risk Completed

Tasty Drops Hemp Oil Extract

Reason Chemical Contamination: product contains elevated levels of undeclared lead.

Michigan Herbal Remedies D-1447-2020
Class III · Low risk Terminated

Famotidine Injection

Reason TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.

HF Acquisition Co. LLC NDC 63323-739-12 D-1392-2020
Class II · Moderate risk Terminated

Metformin HCl Extended Release Tablets

Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Preferred Pharmaceuticals, Inc. D-1364-2020
Class II · Moderate risk Terminated

Childrens Dimetapp Cold & Cough

Reason Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.

Glaxosmithkline Consumer Healthcare Holdings D-1362-2020
Class II · Moderate risk Terminated

Heparin Sodium 5

Reason Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.

SCA Pharmaceuticals NDC 70004-0650-46 D-1311-2020
Class II · Moderate risk Terminated

Tropical Lip Moisturizer

Reason Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate.

Yusef Manufacturing Laboratories, LLC D-1486-2020
Class II · Moderate risk Terminated

Clozapine Tablets USP tablet

Reason Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.

Aurobindo Pharma USA Inc. NDC 65862-846-05 D-1370-2020
Class II · Moderate risk Terminated

Metformin Hydrochloride Extended-Release Tablets

Reason CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.

The Harvard Drug Group NDC 00904-5794-61 D-1360-2020
Class II · Moderate risk Terminated

Koala Hand Sanitizer

Reason Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.

Beaming White Llc D-1359-2020
Class II · Moderate risk Terminated

Koala Hand Sanitizer

Reason Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.

Beaming White Llc D-1358-2020
Class II · Moderate risk Terminated

Koala Hand Sanitizer

Reason Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.

Beaming White Llc D-1357-2020