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Browse Drug Recalls

6,252 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,252 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 6,252 FDA drug recalls.

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DateProductReasonClassFirm
Sep 2, 2016 EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical... Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples. Class I United Exchange Corporation
Aug 24, 2016 Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 ... Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns... Class II Sandoz Inc
Aug 24, 2016 Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 6675... Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns... Class II Sandoz Inc
Aug 16, 2016 Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 ... Non Sterility; contaminated with Klebsiella pneumoniae Class I Sperian Eye & Face Protection, Inc
Aug 10, 2016 Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) ... Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product st... Class II Allergy Laboratories, Inc.
Aug 1, 2016 Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and ... Non-Sterility; microbial contamination identified as Bacillus circulans Class I Town and Country Compounding and Consultation S...
Jul 28, 2016 C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pha... Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were ma... Class II Colonia Care Pharmacy
Jul 28, 2016 C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy,... Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were ma... Class II Colonia Care Pharmacy
Jul 26, 2016 Hyaluronidase, 150 u/ml, 10 ml SDV, Vital Care Compounder, Hattiesburg, MS 39402 Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Methylcobalamin 5,000mcg/ml, 1mL SDV, Rx, Vital Care Compounder, Hattiesburg,... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Hydroxyzine HCl, 50mg/ml Inj, 10ml MDV, Rx, Vital Care Compounder, Hattiesbur... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Buprenorphine, 0.6 mg/ml Injection, 20ml MDV Sterile, Rx, Vital Care Compound... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Pre-Op Pledget Soln + Tetracaine, (Tropicamide (1%) 0.47ml, Phenylephrine (10... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Apomorphine HCl 3mg/ml Sterile Injection Solution, 10 mL, MDV, Rx, Vital Care... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 C-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostagland... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 3... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Trypan Blue 0.3%, 0.5ml vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402 Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Chlorpheniramine Maleate 10 mg/ml, 30 ml MDV, Rx, Vital Care Compounder, Hatt... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Brilliant Blue G (BBG) 0.025%, 0.5 ml SDV, Rx, Vital Care Compounder, Hatties... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 C-PAP/PHEN/PROST/Atrop 150/7.5 (Papaverine 150mg/Phentolamine 7.5mg/Prostagla... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Pre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) 0.33ml, Phenylephrine... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 DMSO 50% with Lidocaine 0.5%, 50ml SDV, Sterile, Rx, Vital Care Compounder, H... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 MOXI/DEX/KETOROLAC 0.5%/0.1%/0.4%, #15, Vital Care Compounder, Hattiesburg, M... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Papaverine 150 mg / Phentolamine 5 mg vials, packaged 5.5 mL in a sterile, cl... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Moxifloxacin 0.5% + Dexamethazone 0.1%, 15ml vial Contains: Moxifloxacin 5mg/... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg, packaged as 5.5... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Olopatadine 0.8% Ophthalmic Solution, 3ml bottle, Rx, Vital Care Compounder, ... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Moxifloxacin HCl 1 mg/ml (0.1mg/0.1ml) and BSS solution, 2ml Single use vial,... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 26, 2016 Morphine Sulfate 15mg/ml Injection, 20 ml MDV, Rx, Vital Care Compounder, Hat... Lack of Assurance of Sterility Class II Pharmacy Plus, Inc. dba Vital Care Compounder
Jul 19, 2016 Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogena... Lack of Assurance of Sterility Class II Talon Compounding Pharmacy
Jul 7, 2016 Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W... Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile envir... Class II Medicap Pharmacy
Jun 29, 2016 TESTOSTERONE CYPIONATE 200mg/ml, 1ML MDV, Vital Care Compounder, Hattiesburg, MS Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vial... Class II Vital Care Compounder, LLC
Jun 20, 2016 Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG, Rx only, THE APOTHECARY, A... Lack of assurance of sterility: This recall includes of all unexpired lots medications containin... Class II W & C dba The Apothecary
Jun 20, 2016 Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE, Rx only, THE APOTHECARY, A... Lack of assurance of sterility: This recall includes of all unexpired lots medications containin... Class II W & C dba The Apothecary
Jun 20, 2016 Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS... Lack of assurance of sterility: This recall includes of all unexpired lots medications containin... Class II W & C dba The Apothecary
Jun 20, 2016 Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE... Lack of assurance of sterility: This recall includes of all unexpired lots medications containin... Class II W & C dba The Apothecary
Jun 20, 2016 Prostaglandin 200 mcg/ 0.1 mL -- 25 mL GLASS VIAL, Rx only, THE APOTHECARY,... Lack of assurance of sterility: This recall includes of all unexpired lots medications containin... Class II W & C dba The Apothecary
May 17, 2016 ESTRADIOL CYPIONATE 10 MG/ML, packaged in 5mL vials, Rx only, Well Care Compo... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 GLUTATHIONE 100MG/ML, packaged in 10 mL vials, Well Care Compounding Pharmacy... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 METHYLCOBALAMIN 1 MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Co... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 QUAD-MIX #3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy L... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 QUAD-MIX #2, packaged in 5mL vial, Rx only, Well Care Compounding Pharmacy La... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 METHYLCOBALAMIN 12.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compound... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 ITRACONAZOLE 0.2%/MUPIROCIN 0.2% NASAL SPRAY; 30 mL Spray, Rx only, Well Car... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 MYERS' COCKTAIL, packaged in 37 mL vials, Rx only, Well Care Compounding Pha... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 SUPER TRI-MIX #4, packaged in 5mL vials, Rx only, Well Care Compounding Pha... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 ALPHA LIPOIC ACID 25MG/ML, packaged in 5mL vials, Rx only, Well Care Compound... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 TRI-MIX # 1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy L... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 METHYLCOBALAMIN 5MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Com... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding 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.