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Browse Drug Recalls

32 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 32 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 32 FDA drug recalls.

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DateProductReasonClassFirm
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 Chlorothiazide 100 mg, 3.57 mL syringe, Made by: Enterprise Pharmacy, 4400 Go... 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.