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Browse Drug Recalls

1,788 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,788 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 1,788 FDA drug recalls in 2019.

Clear
DateProductReasonClassFirm
Apr 10, 2019 Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only... Failed Impurities/Degradation Specifications Class III LUPIN SOMERSET
Apr 10, 2019 Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufac... Failed Impurities/Degradation Specifications Class III LUPIN SOMERSET
Apr 10, 2019 Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only,... Failed Impurities/Degradation Specifications Class III LUPIN SOMERSET
Apr 10, 2019 Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only,... Failed Impurities/Degradation Specifications Class III LUPIN SOMERSET
Apr 9, 2019 Aphrodisiac Platinum 40000, Proprietary Raw Material 6000 mg, 1 count blister... Marketed without an approved NDA/ANDA: FDA analysis has found the product to be tainted with sild... Class I SELECT DISTRIBUTIONS LLC
Apr 8, 2019 BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL... Lack of assurance of sterility for injectables and solutions intended to be sterile. Class II Customceutical Compounding
Apr 8, 2019 GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Pac... Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug r... Class II American Health Packaging
Apr 8, 2019 HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL) inj 5 mL multidose vial... Lack of assurance of sterility for injectables and solutions intended to be sterile. Class II Customceutical Compounding
Apr 8, 2019 Trimix HIGH (Papaverine HCl 30 mg/mL Phentolamine Mesylate 2 mg/mL Alprostadi... Lack of assurance of sterility for injectables and solutions intended to be sterile. Class II Customceutical Compounding
Apr 8, 2019 BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL... Lack of assurance of sterility for injectables and solutions intended to be sterile. Class II Customceutical Compounding
Apr 8, 2019 Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOS... Lack of assurance of sterility for injectables and solutions intended to be sterile. Class II Customceutical Compounding
Apr 8, 2019 Lipoplex (METHIONINE 25 MG/ML INOSITOL 50 MG/ML CHOLINE CHLORIDE 50 MG/ML HYD... Lack of assurance of sterility for injectables and solutions intended to be sterile. Class II Customceutical Compounding
Apr 8, 2019 Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE VIAL MDV Compounded... Lack of assurance of sterility for injectables and solutions intended to be sterile. Class II Customceutical Compounding
Apr 8, 2019 Test PROCYP (TESTOSTERONE CYPIONATE 200MG/ML TESTOSTERONE PROPIONATE 20MG/ML)... Lack of assurance of sterility for injectables and solutions intended to be sterile. Class II Customceutical Compounding
Apr 8, 2019 Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOS... Lack of assurance of sterility for injectables and solutions intended to be sterile. Class II Customceutical Compounding
Apr 8, 2019 TriMix MEDIUM (Papaverine HCL 21 mg/mL Phentolamine Mesylate 0.7 mg/mL Alpros... Lack of assurance of sterility for injectables and solutions intended to be sterile. Class II Customceutical Compounding
Apr 5, 2019 Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufa... Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undecla... Class I Brian P. Richardson
Apr 3, 2019 Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufact... Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer) Class III AVKARE Inc.
Apr 2, 2019 HCG 4,100 Units/vial Injection, Anderson Compounding Pharmacy 310 Bluff City ... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Heparin 2 mL/Lidocaine 2%-10 mL/Sodium Bicarbonate 8.4%-5mL/ Sterile Water 10... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Heparin 10 mL/Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/per 70 mL, An... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 HCG 23 Day, 2876 Units/4.6 mL Vial, Anderson Compounding Pharmacy 310 Bluff C... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Heparin 10 mL/Marcaine 0.25% 20 mL/Sodium Bicarbonate 40 mL/Normal Saline 5 m... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Vitamin D3 200,000 IU/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy ... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 DMSO 50% 60 mL/Heparin 1 mL/ Sodium Bicarbonate 60 mL/ Solu-Cortef 100 mg, 41... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Heparin 10 mL/ Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/ Normal Sali... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Heparin 20,000 U/Lidocaine 2% 10 mL/Sodium Bicarbonate 8.4% 10 mL/Sterile Wat... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Sermorelin 0.3 mg/0.5 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Prostaglandin Quad with Atropine 10:30:1:0.15, 2 mL Vial, Anderson Compoundin... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Prostaglandin Tri-Mix 20:30:1, 10 mL Vial, Anderson Compounding Pharmacy 310 ... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Prostaglandin Tri-Mix 20:25:1 Injection, 2 mL Vial, Anderson Compounding Phar... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Serum Tears 50% Ophthalmic Drops, 1 mL Dropper, Anderson Compounding Pharmacy... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Acetylcysteine 10% Ophthalmic Eye Drop 2 mL droptainer, Anderson Compounding ... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, pr... Failed Impurities/Degradation Specifications: Unknown impurity above specification limits. Class III Johnson Matthey Inc.
Apr 2, 2019 Bacitracin 3000U/30 mL Irrigation, 30 mL Syringe, Anderson Compounding Pharma... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Morphine Sulfate 5 mg/3mL Inhalation, 3 mL Vials, Anderson Compounding Pharma... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 HCG 11,000 Units, 30 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hw... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 HCG 23 Day Injection Extra Strength, vials, Anderson Compounding Pharmacy 310... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Prostaglandin 40 mcg/mL, Vial, Anderson Compounding Pharmacy 310 Bluff City H... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Prostaglandin Tri-Mix 2.5:7.5:0.25 Injection, 2 mL Vial, Anderson Compounding... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Serum Tears 20% Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Blu... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Gentamicin 250 mg/1000 mL Irrigation, 1000 mL, Anderson Compounding Pharmacy ... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Methylcobalamin 3000 mcg/mL Injection Solution, 2 mL Vial, Anderson Compoundi... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 HCG 20 Day Injection, 2625 Units/4 mL, Anderson Compounding Pharmacy 310 Bluf... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Gentamicin 160 mg/1000 mL Sterile Water for Irrigation,1000 mL Bottle, Anders... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Estrone 5mg/mL Oil Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 B... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Dexamethasone 24 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy,... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Heparin 20,000U/Marcaine 0.25%, 10 mL, Sodium Bicarbonate 8.4% 48 mL, 60 mL S... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Streptomycin 24 mg/Dexamethasone 10 mg/mL Otic Injection, 1 mL Syringe, Ander... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Sermorelin 0.4 mg/0.5 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...

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.