Browse Drug Recalls
6,306 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,306 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 6,306 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 17, 2018 | IGF-1 LR3, 620 mcg injection, Rx Only, Promise Pharmacy Compounding Specialis... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Prednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.0... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Ascorbic Acid, Compounded-Tapioca, 450 mg/mL Injection, 50 mL, Rx Only, Promi... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Glutathione Injection, 200 mg/mL, 10 mL, Rx Only, Promise Pharmacy Compoundin... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Sermorelin Theanine/GHRP2, 15 mg/75 mg/5.4 mg injection, Rx Only, Promise Pha... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Epithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists ... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compoundin... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Sermorelin/GHRP2/GHRP6 6mg/3mg/3mg injection, Rx Only, Promise Pharmacy Compo... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | HCG, Human chorionic gonadotropin 5,000 units, injection, Rx Only, Promise Ph... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Nicotinamide Adenine Dinucleotide, 0.5 mg, injection, 10mL vial, Rx Only, Pro... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Zinc Sulfate, 5mg/mL injection, 10ml vial, Rx Only, Promise Pharmacy Compound... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Multi Trace, Zinc/Copper/Manganese/Selenium 5mg/1mg/0.5mg/60mcg/ml, injection... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy ... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | MIC B12+L-Carnitine+Chromium injection, Methionine Inositol Choline Methylcob... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, ... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | HCG, Human chorionic gonadotropin 11,000 units, injection, Rx Only, Promise P... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Lysine HCl, 100 mg/mL injection, 10ml, Rx Only, Promise Pharmacy Compounding ... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL, 10mL vial, Rx Only... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Sermorelin 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists ... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | BPC 157, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Myer's Cocktail, Pyridoxine/Dexpanthenol/Calcium Gluconate/Niacinamide/Vit B6... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Trim Calm, GABA/Magnesium/Taurine/Theanine, 50mg/50mg/50mg/50mg/ml, 10mL vial... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Thymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Speci... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Ipamorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialist... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Bremelanotide (PT 141), 20mg injection, Rx Only, Promise Pharmacy Compounding... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Folic Acid, Injection, 10 mg/mL, 10mL vial, Rx Only, Promise Pharmacy Compoun... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compo... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thi... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 17, 2018 | Zinc Sulfate,10mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compound... | Lack of sterility assurance. | Class II | Promise Pharmacy, LLC |
| Dec 14, 2018 | Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%),... | Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain unde... | Class I | Results RNA, LLC |
| Nov 19, 2018 | Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South ... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Pharm D Solutions, LLC |
| Nov 5, 2018 | puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115,... | Non-Sterility: Product manufactured under non-sterile production conditions. | Class I | Kadesh International |
| Oct 31, 2018 | BEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in n... | Lack of Assurance of Sterility | Class II | Avella of Deer Valley, Inc. Store 38 |
| Oct 29, 2018 | Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial, packaged in... | Defective Container: vial defect was identified that could potentially impact the container closu... | Class II | GE Healthcare Inc. Life Sciences |
| Oct 19, 2018 | Phenylephrine 25 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/... | Lack of assurance of sterility | Class II | Avella of Deer Valley, Inc. Store 38 |
| Oct 19, 2018 | Hydromorphone (0.2 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/... | Lack of assurance of sterility | Class II | Avella of Deer Valley, Inc. Store 38 |
| Oct 19, 2018 | Phenylephrine 30 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/... | Lack of assurance of sterility | Class II | Avella of Deer Valley, Inc. Store 38 |
| Oct 19, 2018 | Fentanyl (10 mcg/mL) in NS 1 mL (in 3mL BD Syringe), Rx only, Advanced Pharma... | Lack of assurance of sterility | Class II | Avella of Deer Valley, Inc. Store 38 |
| Oct 19, 2018 | Morphine (1 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Ave... | Lack of assurance of sterility | Class II | Avella of Deer Valley, Inc. Store 38 |
| Oct 17, 2018 | Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-1... | Lack of Assurance of Sterility | Class II | Qualgen, LLC |
| Oct 17, 2018 | Estradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06)... | Lack of Assurance of Sterility | Class II | Qualgen, LLC |
| Oct 17, 2018 | Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-18... | Lack of Assurance of Sterility | Class II | Qualgen, LLC |
| Oct 17, 2018 | Estradiol 6 mg pellet, 1 count (NDC 69761-006-01), 6 count (NDC 69761-006-06)... | Lack of Assurance of Sterility | Class II | Qualgen, LLC |
| Oct 17, 2018 | Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110... | Lack of Assurance of Sterility | Class II | Qualgen, LLC |
| Oct 17, 2018 | Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-... | Lack of Assurance of Sterility | Class II | Qualgen, LLC |
| Oct 17, 2018 | Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-11... | Lack of Assurance of Sterility | Class II | Qualgen, LLC |
| Oct 17, 2018 | Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-0... | Lack of Assurance of Sterility | Class II | Qualgen, LLC |
| Oct 17, 2018 | Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06)... | Lack of Assurance of Sterility | Class II | Qualgen, 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.