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Browse Drug Recalls

6,228 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,228 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 6,228 FDA drug recalls.

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DateProductReasonClassFirm
Jun 12, 2019 Sodium Chloride 0.9% 1 LITER WITH Potassium Chloride 20 mEq, Mannitol 12.5 G,... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 Cytarabine 128 MG/250 ML D5W IVPB; Cytarabine 20 MG / 1 ML SQ SYRINGE Cytara... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 ATEZOLIZUMAB 1200 MG / 250 ML 0.9% NACL, Rx Only, Infusion Options, Inc. 5924... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 Doxorubicin 110 MG / 55 ML IVP SYRINGE; Doxorubicin 56 MG / 28 ML IVP SYRINGE... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 RITUXIMAB 575 MG / 250 ml 0.9% NACL IVPB; RITUXIMAB 675 MG / 250 ml 0.9% NACL... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 DARATUMUMAB 904 MG QS 500 ML NS IVPB; DARATUMUMAB 668 MG QS 1000 ML NS IVPB, ... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 RAMUCIRUMAB 457 MG QS 250 ML NS IVPB; AMUCIRUMAB 1182 MG QS 250 ML NS IVPB; R... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 GRANISETRON 1000 MCG / 50 ML NS, Rx Only, Infusion Options, Inc. 5924 13the A... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 RomiPLOStim 700 MCG/ 1.4 ML SQ SYR, Rx Only, Infusion Options, Inc. 5924 13th... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 Doxorubicin Liposomal 71 MG / 250 ML D5W IVPB; Doxorubicin Liposomal 66 MG/25... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 Durvalumab 651 mg/ 250 ml NS IVPB; Durvalumab 650 mg/ 250 ml NS IVPB, Rx Only... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 DOCETAXEL 60 MG / 250 ml D5W IVPB; DOCETAXEL 71 MG/ 250 ML NS IVPB; DOCETAXEL... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 ERBITUX 770 MG/ 385 ML IVPB; ERBITUX 440 MG/ 220 ml IVPB; ERBITUX 850 MG/ ... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 PANITUMUMAB 400 MG / 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13t... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 INJECTAFER 720 MG in 100 ml NS IVPB; INJECTAFER 210 MG in 100 ml NS IVPB, Rx ... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 NIVOLUMAB 480 MG / 100 ML NS IVPB; NIVOLUMAB 200 mg / 100 ML NS IVPB; NIVOLUM... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 AVASTIN 630 MG / 100 ML 0.9% NACL IVPB; AVASTIN 2.5 mg/ 0.1ML Syringe; AVASTI... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 PACLITAXEL PROTEIN 175 MG/100 ML NS IVPB; PACLITAXEL PROTEIN 190 MG/100 ML NS... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 VINCRISTINE 1 MG /50 ML NS IVPB; VINCRISTINE 1.2 MG /50 ML NACL 0.9% IVPB; VI... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G; Cisplatin 80 MG / 250 ml... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 CARBOPLATIN 174 MG / 250ml NS IVPB; CARBOPLATIN 240 MG / 250 ML NS IVPB; CARB... Lack of Assurance of Sterility Class II Infusion Options, Inc.
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 30, 2019 Trisodium Citrate 0.5% CRRT SOLUTION. RX Only. Rx # specific and Patient Spec... Lack of sterility assurance. Class II Surgery Pharmacy Services Inc
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 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 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 &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 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 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 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 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 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 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 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 (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 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 Lipo MIC-12 (Methylcobalamin, USP 1mg, Methionine USP 15mg, Inositol, FCC 50m... 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 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 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 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 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 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 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 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 Oxytocin 30 units in NS 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf A... 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.