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.

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DateProductReasonClassFirm
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.