Browse Drug Recalls
1,732 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,732 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 1,732 FDA drug recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 20, 2018 | Dr. King's SafeCare Rx Children's Cough Children High Potency Homeopathic For... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's SafeCare Rx No Sweat/Anti-Perspirant, 2 fl. oz. (59 mL), King Bio,... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's Natural Medicine Homeopathic Heavy Metal Detox, 2 fl. oz. (59 mL),... | Microbial contamination | Class I | King Bio Inc. |
| 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. |
| 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 | 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 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 |
| Jun 4, 2018 | Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Si... | Presence of Particulate Matter; Potential for particulate matter on the syringe plunger. | Class I | HOSPIRA INC, LAKE FOREST |
| May 24, 2018 | Allergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians... | Contraceptive Tablets Out of Sequence. | Class I | Allergan, PLC. |
| May 17, 2018 | 7K capsules packaged in single packs sold in 24-count boxes, Distributed by S... | Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenaf... | Class I | Shoreside Enterprises Inc. |
| May 17, 2018 | POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-cou... | Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenaf... | Class I | Shoreside Enterprises Inc. |
| May 8, 2018 | Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single... | Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency | Class I | Apotex Inc. |
| May 8, 2018 | Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Sing... | Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency | Class I | Apotex Inc. |
| May 1, 2018 | Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular... | Presence of Particulate Matter: confirmed customer report of the presence of visible particulate ... | Class I | AuroMedics Pharma LLC |
| May 1, 2018 | Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intr... | Presence of Particulate Matter: confirmed customer report for presence of visible particulate mat... | Class I | AuroMedics Pharma LLC |
| Apr 16, 2018 | Euphoric Premium Male Performance Enhancer capsules, packaged in a)1-count bl... | Marketed Without An Approved NDA/ANDA: product contains undeclared sildenafil, tadalafil, and oxy... | Class I | Epic Products, LLC |
| Apr 12, 2018 | Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by... | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadal... | Class I | AMA Wholesale |
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.