Browse Drug Recalls

2,165 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,165 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 2,165 FDA drug recalls.

Clear
DateProductReasonClassFirm
Jul 20, 2018 Dr. King's Natural Medicine Homeopathic Climate Adaptation Cold & Damp, 2 fl.... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx Gout Symptom Relief, 2 fl. oz. (59 mL), King Bio, Inc.... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx Smoke Control, 2 fl. oz. (59 mL), King Bio, Inc., 3 We... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx CS-Lymph Hodgkins, 2 fl. oz. (59 mL), King Bio, Inc., ... Microbial contamination Class I King Bio Inc.
Jul 20, 2018 Dr. King's SafeCare Rx LymePlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westsid... Microbial contamination Class I King Bio Inc.
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 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 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
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, Plantation White MD, 1oz, 250g, 1kg ... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, Purple 8-1, 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 Bali, 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, Plantation Red MD, 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, Red Borneo, 1oz, 250g, 1kg packages... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC
May 22, 2018 READYFLUSH PROTECT with Dimethicone (3.2%), Flushable Personal Cleaning Cloth... Microbial Contamination of a Non-Sterile Product. Class II Medline Industries Inc (Northpoint Services)
May 16, 2018 Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches... Microbial contamination of NonSterile Product; FDA analysis returned out of specification results... Class II Inopak Ltd
May 4, 2018 B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatol... Microbial Contamination of Non-sterile Product Class II Milbar Laboratories, Inc.
May 1, 2018 Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Ma... GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violatio... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
May 1, 2018 Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Ma... GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violatio... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Apr 11, 2018 NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Pre... Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... Class II Premier Pharmacy Labs Inc
Apr 11, 2018 Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syri... Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... Class II Premier Pharmacy Labs Inc
Apr 11, 2018 Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syri... Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... Class II Premier Pharmacy Labs Inc
Apr 11, 2018 Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. ... Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... Class II Premier Pharmacy Labs Inc
Apr 6, 2018 Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bott... Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisino... Class III Sandoz Incorporated
Mar 30, 2018 PASTA DE LASSAR ANDROMACO Skin Protection, 25% zinc oxide Topical cream, 60 g... Microbial Contamination of Non-Sterile Products Class II Marcas Usa Llc
Mar 5, 2018 Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johns... Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morph... Class II Johnson Matthey Inc.
Feb 14, 2018 SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 515... Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paeci... Class II Fagron, Inc
Dec 28, 2017 Earth's Care Eczema Lotion (2% Colloidal Oatmeal) Skin Protectant with Aloe a... Microbial Contamination of Non-Sterile Products. Class II DLC Laboratories, Inc
Dec 19, 2017 Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX O... Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalpro... Class II Unichem Pharmaceuticals Usa Inc

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.