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Browse Drug Recalls

1,681 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,681 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 1,681 FDA drug recalls in 2018.

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DateProductReasonClassFirm
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 Omeprazole 4 mg/mL Suspension, 150cc to 300 cc per prescription, Rx only, Du... Lack of Processing Controls. Class II Duren Health Mart Pharmacy
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 Testosterone 0.1% cream, 30 grams, Rx only, Duren's Health Mart Pharmacy 215 ... Lack of Processing Controls. Class II Duren Health Mart Pharmacy
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 Progesterone 10% cream, 12gm to 30gm per prescription, Rx only, Duren's Healt... Lack of Processing Controls. Class II Duren Health Mart Pharmacy
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 Domperidone 10 mg capsules, 100-count per prescription, Rx only, Duren's Hea... Lack of Processing Controls. Class II Duren Health Mart Pharmacy
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
Dec 17, 2018 Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Com... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 14, 2018 Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufa... Failed Dissolution Specifications. Class II Cipla Limited
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
Dec 11, 2018 Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: K... Labeling: Wrong bar code Class II KVK-Tech, Inc.
Dec 11, 2018 Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Eno... Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recall... Class I Asclemed USA Inc. dba Enovachem
Dec 11, 2018 Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Eno... Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recall... Class I Asclemed USA Inc. dba Enovachem
Dec 10, 2018 Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as o... Superpotent Drug: contains higher levels of Iron than labeled. Class II Gordon Laboratories
Dec 10, 2018 Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, ... Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients. Class III CBI Laboratories, Inc.
Dec 10, 2018 Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx... Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification ... Class II Dr. Reddy's Laboratories, Inc.
Dec 10, 2018 Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenz... Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients. Class III CBI Laboratories, 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.