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.

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DateProductReasonClassFirm
May 30, 2019 Memorial Central TPN. Rx Only, Rx # specific and Patient Specific volumes. M... Lack of sterility assurance. Class II Surgery Pharmacy Services Inc
May 23, 2019 Sermorelin/GHRP-2 & 6 (3-3-3 MG) vials, Pharm D. Solutions 1304 South Loop We... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Sermorelin/GHRP-2 &6 (9-9-9 mg) vials, Pharm D. Solutions 1304 South Loop Wes... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Human Chorionic Gonadotropin 5,000 IU vials, Rx only, Pharm D. Solutions 1304... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 B-complex (Thiamine 100mg, Riboflavin 2mg, Niacinamide 100 mg, Pyridoxine 2mg... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Nandrolone Decanoate 200 mg/mL Injectable, 10 mL vials, Rx only, Pharm D. Sol... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Human Chorionic Gonadotropin 10,000 IU vials, Rx only Pharm D. Solutions 130... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Testosterone Cyp/Pro 95/5%, 10 mL vials, Rx only, Pharm D. Solutions 1304 S... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Ipamorelin Acetate 9 mg/9mL Injectable vials, Rx only, Pharm D. Solutions 130... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Bacteriostatic Water for Injection, 10 mL vials, Pharm D. Solutions 1304 Sout... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Sermorelin/Ipamorelin 18 mg/15 mg, 10mL vials, Rx only, Pharm D. Solutions 13... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Trimix 30mg/1 mg/10mcg/mL ( 30 mg Papaverine, 1mg phentolamine mesylate, 30 m... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Sermorelin/GHRP-2 9 mg/9 mg vials Pharm D. Solutions 1304 South Loop West, Ho... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Testosterone 200 mg/mL, 30 mL vials, Rx only, Pharm D. Solutions 1304 South L... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Sermorelin/GHRP-2 &6 (9-9-9-mg) vials, Pharm D. Solutions 1304 South Loop Wes... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Sermorelin/GHRP-2 9 mg/6 mg vials, Rx only, Pharm D. Solutions 1304 South Loo... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Human Chorionic Gonadotropin 12,000 IU vials Pharm D. Solutions 1304 South L... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Testosterone Cypionate 200 mg/mL, in a) 5mL vials and b)10 mL vials, Rx only,... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Lipo MIC-12 (Methylcobalamin, USP 1mg, Methionine USP 15mg, Inositol, FCC 50m... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 21, 2019 PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx On... Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL ... Class I Heritage Pharmaceuticals, Inc.
May 21, 2019 AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only,... Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL ... Class I Heritage Pharmaceuticals, Inc.
May 3, 2019 Bevacizumab 2.5 mg/0.1 mL, packaged in a Prefilled Syringe, Rx only, AVELLA S... Lack of assurance of sterility Class II Avella of Deer Valley, Inc. Store 38
Apr 30, 2019 Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL V... Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufac... Class II Sagent Pharmaceuticals 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 Magnesium Sulfate 2 GM in NS 50 mL bag, 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.