Browse Drug Recalls

17,874 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,874 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 17,874 FDA drug recalls.

DateProductReasonClassFirm
Jun 18, 2020 Tasty Drops, Hemp Oil Extract, Spearmint, 1500MG CBD,1 FL. OZ (30ML) bottles,... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 Goodness Gurus, Healthy Hemp Drops, 500MG/Berry, 1 FL. OZ bottles, Distribute... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 Tasty Drops, Hemp Oil Extract, Berry, 1500MG CBD, 1 FL. OZ (30ML) bottles, Di... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 Herbzeedy, Hemp Oil Full Spectrum, Natural, 1500 MG CBD, 1 FL OZ (30 ML) bott... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 Made by Hemp 1000MG Hemp Extract, Mojito Lime, 1 OZ (30 ML) bottles, Dist by:... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 Recovery Releaf, Pure CBD Oil, Vanilla, 1000MG, 25MG per serving, 1 fl. oz (3... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Natural 500MG CBD, 1 FL. OZ... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 Tasty Drops Hemp Oil Extract, Berry, 1 FL. OZ (30ML) bottles, 300MG CBD, Dist... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Spearmint, 500mg CBD, 1 FL.... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 Goodness Gurus, Healthy Hemp Drops, 1500 MG/Spearmint, 1 FL. OZ bottles, Dist... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 Tasty Drops, Hemp Oil Extract, Berry, 500MG CBD, 1 FL. OZ (30ML) bottles, Dis... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Natural, 1000MG CBD, 1 FL. ... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 Tasty Drops, Hemp Oil Extract, Spearmint, 1000MG CBD, 1 FL. OZ (30ML) bottles... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 Tasty Drops, Hemp Oil Extract, Vanilla, 500MG CBD, 1 FL. OZ (30ML) bottles, D... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 Goodness Gurus, Healthy Hemp Drops, 500MG/Spearmint, 1 FL. OZ bottles, Distri... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 18, 2020 Tasty Drops, Hemp Oil Extract, Natural, 1500MG CBD, 1 FL. OZ (30ML) bottles, ... Chemical contamination: product contains elevated levels of undeclared lead. Class I MICHIGAN HERBAL REMEDIES
Jun 17, 2020 Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage X... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acce... Class II Preferred Pharmaceuticals, Inc.
Jun 17, 2020 Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, F... TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerat... Class III HF Acquisition Co. LLC
Jun 16, 2020 Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), ... Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint. Class II SCA Pharmaceuticals
Jun 16, 2020 Childrens Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ. bottle, (23... Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups. Class II Glaxosmithkline Consumer Healthcare Holdings
Jun 16, 2020 Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (c... Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups. Class II Glaxosmithkline Consumer Healthcare Holdings
Jun 13, 2020 Tropical Lip Moisturizer, SPF 30, UVA/UVB Lip Protection, Active Ingredients:... Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent ... Class II Yusef Manufacturing Laboratories, LLC
Jun 12, 2020 Koala Hand Sanitizer, Unscented, 16 FL OZ., Antibacterial, (Ethyl Alcohol 70... Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undec... Class II Beaming White Llc
Jun 12, 2020 Koala Hand Sanitizer, Soothing Eucalyptus, 16 FL OZ., Antibacterial, (Ethyl ... Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undec... Class II Beaming White Llc
Jun 12, 2020 Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (1... CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established... Class II The Harvard Drug Group
Jun 12, 2020 Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed b... Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 cou... Class II Aurobindo Pharma USA Inc.
Jun 12, 2020 Koala Hand Sanitizer, Menthol, 16 FL OZ., Antibacterial, (Ethyl Alcohol 69%)... Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undec... Class II Beaming White Llc
Jun 11, 2020 Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Lupin Pharmaceuticals Inc.
Jun 11, 2020 Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured b... Defective Container: Customer complaints received of a crimp defect while removing the flip-cap d... Class II Hikma Pharmaceuticals USA Inc.
Jun 11, 2020 Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured b... Defective Container: Customer complaints received of a crimp defect while removing the flip-cap d... Class II Hikma Pharmaceuticals USA Inc.
Jun 10, 2020 Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured a... Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP. Class II Crown Laboratories
Jun 10, 2020 Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blis... Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medi... Class III American Health Packaging
Jun 10, 2020 Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured ... Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP. Class II Crown Laboratories
Jun 10, 2020 Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured... Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tabl... Class II Alembic Pharmaceuticals Limited
Jun 9, 2020 Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, 90 capsules per bottle,... Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and b... Class I MasterPharm LLC
Jun 5, 2020 Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Marksans Pharma Limited
Jun 5, 2020 Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx onl... Discoloration: Out of Specification (OOS) result for APHA Color Test. Class III Akorn, Inc.
Jun 5, 2020 metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II PD-Rx Pharmaceuticals, Inc.
Jun 5, 2020 metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II PD-Rx Pharmaceuticals, Inc.
Jun 4, 2020 Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactu... Failed Impurities/Degradation Specification: There is a slow leaching process from the product l... Class III SOMERSET THERAPEUTICS LLC
Jun 4, 2020 Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II AVKARE Inc.
Jun 4, 2020 Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufact... Failed Impurities/Degradation Specification: There is a slow leaching process from the product l... Class III SOMERSET THERAPEUTICS LLC
Jun 4, 2020 Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufact... Failed Impurities/Degradation Specification: There is a slow leaching process from the product l... Class III SOMERSET THERAPEUTICS LLC
Jun 4, 2020 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (ND... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II AVKARE Inc.
Jun 3, 2020 Walker Emulsions Hand Sanitizer (60%), Non-Sterile Solution, Alcohol Antisept... Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a... Class II WALKER EMULSIONS INC
Jun 3, 2020 Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradim... Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim. Class II Yusef Manufacturing Laboratories, LLC
Jun 3, 2020 Walker Hand Sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70%, 32 oz a... Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a... Class II WALKER EMULSIONS INC
Jun 3, 2020 Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. (4... cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specificat... Class II A.P. Deauville, LLC
Jun 2, 2020 Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 620... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Teva Pharmaceuticals USA
Jun 2, 2020 Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC ... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Teva Pharmaceuticals USA

Frequently Asked Questions

When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.