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Browse Drug Recalls

6,220 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,220 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 6,220 FDA drug recalls.

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DateProductReasonClassFirm
Aug 6, 2020 Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Fa... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Rx only, Family Pharmac... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmac... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Methylcobalamin 1 mg/mL Injectable in 1 mL syringes, Rx only, Family Pharmacy... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesvill... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 m... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of S... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharm... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Morphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Jul 20, 2020 Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose... Lack of Assurance of Sterility; potential loose metal overseal crimp defects. Class II Pfizer Inc.
Jul 7, 2020 BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the la... Class I CareFusion 213, LLC
Jul 7, 2020 BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v... Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the la... Class I CareFusion 213, LLC
Jun 29, 2020 Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutane... Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber ... Class II EMD Serono, Inc.
Jun 23, 2020 BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) an... Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides Class I CareFusion 213, LLC
Jun 23, 2020 ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides Class I CareFusion 213, LLC
Jun 23, 2020 ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides Class I CareFusion 213, LLC
May 11, 2020 Sterile Curcumin 50mg/mL, 10 mL vial Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... Class II BIOTA Biosciences LLC
May 11, 2020 Sterile Curcumin, 4mg/mL, 10mL vial Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... Class II BIOTA Biosciences LLC
May 11, 2020 Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... Class II BIOTA Biosciences LLC
May 11, 2020 Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... Class II BIOTA Biosciences LLC
May 11, 2020 Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... Class II BIOTA Biosciences LLC
Mar 26, 2020 Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INN... Lack of Assurance of Sterility Class II Innovative Intrathecal Solutions, Inc. dba Inno...
Mar 26, 2020 Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln, 5 mL, Injecta... Lack of Assurance of Sterility Class II Innovative Intrathecal Solutions, Inc. dba Inno...
Mar 26, 2020 Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable, Rx only, INN... Lack of Assurance of Sterility Class II Innovative Intrathecal Solutions, Inc. dba Inno...
Mar 26, 2020 MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml) , 10 mL, ... Lack of Assurance of Sterility Class II Innovative Intrathecal Solutions, Inc. dba Inno...
Mar 26, 2020 Methylcobalamin Soln. 1000 mcg/ml, 10 mL, Injectable, Rx only, INNOVATIVE CO... Lack of Assurance of Sterility Class II Innovative Intrathecal Solutions, Inc. dba Inno...
Mar 19, 2020 Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25... Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for ... Class II Edge Pharma, LLC
Mar 19, 2020 Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml... Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for ... Class II Edge Pharma, LLC
Mar 16, 2020 ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe,... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, ... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tam... Lack of Assurance of Sterility Class II The Medicine Shoppe Pharmacy
Mar 16, 2020 HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, F... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare B... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, Fo... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 ... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL B... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 16, 2020 ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride ... Firm is recalling 46 lots of various products because of a lack of sterility assurance. Class II PharMEDium Services, LLC
Mar 13, 2020 C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharma... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Medical Center Pharmacy, Inc.
Mar 13, 2020 *Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Ph... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Medical Center Pharmacy, Inc.
Mar 13, 2020 C-*Albumin Eye Drop 10% S, packaged in 10 mL bottles, Rx only, Medical Center... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Medical Center Pharmacy, Inc.
Mar 13, 2020 *Morphine 2 mg/mL Cassette, 100 mL CADD Cassette, Rx only, Medical Center Pha... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Medical Center Pharmacy, Inc.
Mar 13, 2020 C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Me... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Medical Center Pharmacy, Inc.
Feb 27, 2020 Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distri... Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The... Class II Pfizer Inc.
Feb 3, 2020 Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dos... Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects... Class II Pfizer Inc.

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.