Browse Drug Recalls

1,681 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,681 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 1,681 FDA drug recalls in 2018.

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DateProductReasonClassFirm
Jul 11, 2018 Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 10... Failed Stability Specifications: lot out of specification for elevated water vapor. Class III Renaissance Lakewood, LLC
Jul 10, 2018 Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dos... Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or e... Class III Valeant Pharmaceuticals North America LLC
Jul 9, 2018 Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bot... Subpotent Drug Class III Mylan Pharmaceuticals Inc.
Jul 5, 2018 alba BOTANICA sport mineral sunscreen (titanium dioxide 7.0% and zinc oxide 9... Incorrect Product Formulation: wrong sunscreen product in the package. Class II The Hain Celestial Group, Inc. - Worldwide HQ
Jul 5, 2018 Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection,... Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature. Class II Sanofi-Aventis U.S. LLC
Jul 5, 2018 Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, ... Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) t... Class II Teva Pharmaceuticals USA
Jul 3, 2018 Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application... CGMP Deviations: The manufacturer of this product recalled because they were not manufactured und... Class II Medgyn Products, Inc.
Jul 3, 2018 Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL),... CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a... Class II Medi-Fare Drug and Home Health Center
Jul 3, 2018 Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a ... Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, ... Class II Sun Pharmaceutical Industries, Inc.
Jul 2, 2018 Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Do... Presence of Particulate Matter: identified as glass and silicone material Class I AuroMedics Pharma LLC
Jun 29, 2018 Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic ... Subpotent Drug: Stability data does not support the current expiration dating of 55 days after co... Class II SCA Pharmaceuticals
Jun 29, 2018 Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 m... Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 ... Class I Fagron Compounding Services LLC dba Fagron Ster...
Jun 29, 2018 Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 m... Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 ... Class I Fagron Compounding Services LLC dba Fagron Ster...
Jun 28, 2018 Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per... Microbial Contamination of Sterile Products: Product associated with reports of adverse events in... Class II PFIZER
Jun 28, 2018 Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufac... Subpotent Drug and Failed Content Uniformity. Class II LUPIN SOMERSET
Jun 27, 2018 Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Ph... Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... Class III Aidarex Pharmaceuticals LLC
Jun 27, 2018 Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex ... Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... Class III Aidarex Pharmaceuticals LLC
Jun 27, 2018 Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Ph... Out-of-specification results for the Enalapril Diketopiperazine degradation product during commer... Class III Aidarex Pharmaceuticals LLC
Jun 26, 2018 Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per car... Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was reca... Class III MAJOR PHARMACEUTICALS
Jun 26, 2018 Blissful Remedies Red Maeng Da, 100% Mitragyna Speciosa capsule, 50-count pac... Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its p... Class I World Organix, LLC
Jun 26, 2018 Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, 12mL bottle.... Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its p... Class I World Organix, LLC
Jun 26, 2018 Blissful Remedies, 4 Hour Chill, Slow Motion Blend, Herbal Shot. 1.93 Fluid ... Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its p... Class I World Organix, LLC
Jun 26, 2018 Blissful Remedies Kratom+CBD CBD infused Maeng Da, capsules 50-count packaged... Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its p... Class I World Organix, LLC
Jun 26, 2018 Blissful Remedies Gold Series Ultra Enhanced Indo, 50 capsule, packaged in Wh... Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its p... Class I World Organix, LLC
Jun 26, 2018 Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per c... Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was reca... Class III MAJOR PHARMACEUTICALS
Jun 25, 2018 Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Wate... Lack of Processing Controls: products produced in a manner that calls into question the sterility... Class II La Vita Compounding Pharmacy, LLC
Jun 25, 2018 Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water)... Lack of Processing Controls: products produced in a manner that calls into question the sterility... Class II La Vita Compounding Pharmacy, LLC
Jun 25, 2018 Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 ca... Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT d... Class III AMERICAN HEALTH PACKAGING
Jun 25, 2018 Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water)... Lack of Processing Controls: products produced in a manner that calls into question the sterility... Class II La Vita Compounding Pharmacy, LLC
Jun 22, 2018 eb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hy... Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity Class II Eb5 Corporation
Jun 22, 2018 Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by ... CGMP Deviations Class II Akorn, Inc.
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, Red Kapuas Hulu , 1oz, 250g, 1kg pac... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, Red Dragon, 1oz, 250g, 1kg packages,... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, Bali Gold, 1oz, 250g 1kg packages, G... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, Green Dragon, 1oz, 250g, 1kg package... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, Green Thai, 1oz, 250g, 1kg packages,... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, Elephant, 1oz, 250g, 1kg packages, G... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, White Borneo, 1oz, 250g, 1kg package... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, Yellow Vietnam, 1oz, 250g, 1kg packa... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, Green Kapuas Hulu, 1oz, 250g, 1kg pa... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, Ganesh, 1oz, 250g, 1kg packages, Gai... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, Green Malay, 1oz, 250g, 1kg packages... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, White Thai, 1oz, 250g, 1kg packages,... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, White MD, 1oz, 250g, 1kg packages, G... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, Green MD, 1oz, 250g, 1kg packages, G... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, Yellow Thai, 1oz, 250g, 1kg packages... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, Red Horn, 1oz, 250g, 1kg packages, G... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, Green Horn, 1oz, 250g, 1kg packages,... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, Red MD, 1oz, 250g, 1kg packages, Gai... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, White Horn, 1oz, 250g, 1kg packages,... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC

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.