Browse Drug Recalls
6,322 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,322 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 6,322 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush Syringe, Made by: Enterpris... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | Norepinephrine 16 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Gol... | 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 | Vancomycin 1250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf ... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| 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 | 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 | Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, Made by: Ent... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | Magnesium Sulfate 1 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Go... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, Made by: ... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | Magnesium Sulfate 4 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Go... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | Alteplase 1 mg/mL 1 mL in 10 mL syringe, Made by: Enterprise Pharmacy, 4400 G... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | NICARdipine 25 mg in NS 250 mL EXCEL bag, Made by: Enterprise Pharmacy, 4400 ... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | Oxytocin 30 units in NS 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf A... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | Vancomycin 1000 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf ... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | Diltiazem 250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Ac... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | Phenylephrine 20 mg NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Ac... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 mL) syringe, Made by: En... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | CeFAZolin 1 GM a) in NS 100 mL bag; b) 100 mg/mL (10 mL) syringe, Made by: En... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | Lidocaine 1% - Sodium Bicarb 8.4% 10:1, 10 mL syringe, For Intradermal Use On... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use... | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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... |
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.