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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 12, 2019 | Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 ... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Ph... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | Sodium Bicarbonate 150 mEq in D5W 1000 mL bags, Made by: Enterprise Pharmacy,... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | CeFAZolin 3 gm 100 mg/mL, 30 mL syringe, Made by: Enterprise Pharmacy, 4400 G... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | Chlorothiazide 100 mg, 3.57 mL syringe, Made by: Enterprise Pharmacy, 4400 Go... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | Vancomycin 1500 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf ... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| 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 | 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 | 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 | 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 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 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 | 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 | 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 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 | 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 2, 2019 | HCG 1,000 U/mL Injection, 30 mL, Vial Anderson Compounding Pharmacy 310 Bluff... | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Methionine 15mg/Choline 100mg/ Inositol 50mg/ Methylcobalamin 1mg/ Lidocoaine... | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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... |
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.