Browse Drug Recalls

17,897 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,897 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 17,897 FDA drug recalls.

DateProductReasonClassFirm
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 Gentamicin 240 mg/500 mL Sterile Water for Irrigation,60 mL Syringe, Anderson... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Gentamicin 120 mg/250 mL 0.9% Sodium Chloride for Irrigation, 30 mL Syringe, ... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Sodium Bicarbonate 8.4% Injection, 10 mL Vial, Anderson Compounding Pharmacy ... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 HCG 40 Day Injection Extra Strength, vials, Anderson Compounding Pharmacy 310... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Estradiol Cypionate 10 mg/mL, 5 mL Vial, Anderson Compounding Pharmacy 310 Bl... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 HCG 30 Day, 3750 Units/6 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bl... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 HCG 20,000 units/vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bris... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Prostaglandin Tri-Mix 60:30:1 Injection, 2 mL Vial, Anderson Compounding Phar... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Methylcobalamin 1 mg/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy 3... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 EDTA 1% Sterile Injection (Preservative Free), Anderson Compounding Pharmacy ... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Neomycin 40 mg/Polymixin B 200,000 Bladder Irrigation Solution, 1000 mL bottl... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Amphotericin B 0.15% Eye Drops, 2 mL Droppers, Anderson Compounding Pharmacy ... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Papaverine 30 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 ... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Prostaglandin 60 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 Methylprednisolone 1% PF Ophthalmic, 3 mL Droppers, Anderson Compounding Phar... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Interferon 1 Million IU/mL Eye Drops, 1 mL Droptainer, Anderson Compounding P... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 HCG 11,00Units/B 12 11,000 mcg Injection, 30 mL Vial, Anderson Compounding Ph... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Prostaglandin Tri-Mix 5:15:0.5 Injection, 2 mL Vial, Anderson Compounding Pha... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Vancomycin 125 mg/3mL Inhalation, 3 mL Vial, Anderson Compounding Pharmacy 31... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Papaverine 30 mg/Phentolamine 0.5 mg/mL, 2 mL Vial, Anderson Compounding Phar... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Heparin 10,000 U/Bupivacaine 0.5% 10 mL, Sodium Bicarbonate 8.4% 50 mL, 61 mL... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Lidocaine 1%/Dextrose 12.5% (PF) Injection, 10 mL Vial, Anderson Compounding ... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Atropine 0.01% Eye Drops, 1 mL and 2 mL Dropper, Anderson Compounding Pharmac... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Prostaglandin Tri-Mix 30:30:1 Injection, 2 mL Vial, Anderson Compounding Phar... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Serum Tears 30% Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Blu... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Penicillin G 100,000/mL 10 mL Syringe, Anderson Compounding Pharmacy 310 Bluf... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Testosterone Cypionate 250 mg/mL Sterile Injection, 5 mL Vial, Anderson Compo... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Prostaglandin Tri-Mix 8.33:22.5:0.833 Injection, 2 mL Vial, Anderson Compound... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Polyhexamethylene Biguanide 0.02% Ophthalmic Drops, 2 mL Dropper, Anderson Co... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Phenylephrine 1 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy 31... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 HCG 20 Day Extra Strength, 3500 Units/4 mL, 10 mL Vial, Anderson Compounding ... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Prostaglandin Quad-Mix 20:30:1:0.15 Injection, 10 mL Vial, Anderson Compoundi... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Phenol 10% Injection, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Prostaglandin Tri-Mix 50:30:1, 10 mL Vial, Anderson Compounding Pharmacy 310 ... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Prostaglandin 20 mcg/mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff ... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
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...

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.