Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 22, 2019 | Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a... | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... | Class II | Inopak Ltd |
| Apr 22, 2019 | ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Fo... | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... | Class II | Inopak Ltd |
| Apr 22, 2019 | AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium ch... | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... | Class II | Inopak Ltd |
| Apr 22, 2019 | Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | RemedyRepack Inc. |
| Apr 22, 2019 | Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 m... | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... | Class II | Inopak Ltd |
| Apr 22, 2019 | Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with T... | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... | Class II | Inopak Ltd |
| Apr 22, 2019 | Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soa... | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... | Class II | Inopak Ltd |
| Apr 22, 2019 | INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 05857... | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... | Class II | Inopak Ltd |
| Apr 22, 2019 | INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) ... | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... | Class II | Inopak Ltd |
| Apr 22, 2019 | Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE San... | CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing pra... | Class II | Inopak Ltd |
| Apr 19, 2019 | BEVACIZUMAB 1.25 mg/0.05 mL 31G MJ syringe Intravitreal Injection. This biol... | Defective Delivery System: difficult to express | Class II | Pacifico National, Inc. dba AmEx Pharmacy |
| Apr 18, 2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Apr 18, 2019 | Losartan Potassium Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Apr 18, 2019 | Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)10... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Apr 18, 2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) 30-c... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Apr 18, 2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-co... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Apr 18, 2019 | Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)10... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Apr 15, 2019 | Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx ... | Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterili... | Class II | Iso-Tex Diagnostics, Inc |
| 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 | 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 | 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 | Magnesium Sulfate 2 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Go... | 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 | DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL bag) ... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL ... | Subpotent Product: assay results for Amoxicillin were below the specification limits. | Class II | Teva Pharmaceuticals USA |
| 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 | 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 | 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 | Heparin Pork 30,000 Units in NS 1000 mL bag, Made by: Enterprise Pharmacy, 44... | 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 | 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 6 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Go... | 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 | Vancomycin 2000 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 | Clindamycin 900 mg in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf A... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | Lidocaine Buffered with J-Tip 0.25 mL, 1 mL syringe, 10:1, For Intradermal Us... | 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 | Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 44... | 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 | CefTRIAXone 1 GM, 100 mg/mL, 10 mL syringe, Made by: Enterprise Pharmacy, 440... | 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 | 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 | Vancomycin 1500 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf ... | 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 | 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 | 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 | 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 | 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 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 |
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.