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Browse Drug Recalls

52 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 52 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 52 FDA drug recalls.

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DateProductReasonClassFirm
Jun 30, 2021 MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50... Lack of processing controls Class II Promise Pharmacy, LLC
Dec 17, 2018 Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding... 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 Sermorelin 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists ... 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 Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy ... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Procaine HCl, 2% injection, 10ml vial, Rx Only, Promise Pharmacy Compounding ... 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 Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, ... 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 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 IGF-1 LR3, 620 mcg injection, Rx Only, Promise Pharmacy Compounding Specialis... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Trim Complete, Methlonine/Inositol/Choline/Thiamine/Riboflavin/Niacinamide De... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Methylcobalamin lyophilized 50,000 mcg Injection, Rx Only, Promise Pharmacy C... 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 Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, ... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Melanotan II, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialis... 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 Bremelanotide (PT 141), 20mg injection, Rx Only, Promise Pharmacy Compounding... 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 Pyridoxine HCl, 100 mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Com... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09... 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 HCG, Human chorionic gonadotropin 2,000 units, injection, Rx Only, Promise Ph... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Ipamorelin+Sermorelin, 15mg/15mg, injection, Rx Only, Promise Pharmacy Compou... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Niacinamide injection, 100mg/mL, 5mL vial, Rx Only, Promise Pharmacy Compound... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Sermorelin/GHRP2/GHRP6, 9 mg/9 mg/9 mg injection, Rx Only, Promise Pharmacy C... 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 IGF-1-LR3, 3 mg injection, Rx Only, Promise Pharmacy Compounding Specialists ... 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 Epithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists ... 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 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 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 Zinc Sulfate,10mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compound... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Ipamorelin, 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%,... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialist... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx... 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 MIC B12+L-Carnitine+Chromium injection, Methionine Inositol Choline Methylcob... 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 Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compoundin... 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 Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection, Rx Only, Promise Pharmacy C... 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 Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thi... 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 Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compo... 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

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.