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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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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
Aug 27, 2014 Hydromorphone/bupivacaine (PF) 0.5 mg/0.2 mg/mL injectable packaged in 30 mL ... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Sodium tetradecyl sulfate 2% (PF) injectable packaged in an amber glass injec... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Triamcinolone acetonide (PF) 40 mg/mL injection suspension packaged in an amb... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Bupivacaine hydrochloride 0.25% injectable packaged in an amber glass injecta... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Tri-mix T106, 30 mg/1 mg/25 mcg/mL (papaverine, phentolamine mesylate, alpros... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Prednisolone acetate 50 mg/mL injectable packaged in an amber glass injectabl... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Bacteriostatic water for injection packaged in an amber glass injectable vial... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Tri-mix, 15 mg/0.5 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostad... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Fentanyl/bupivacaine 3000 mcg/30 mg/mL injectable packaged in 30 mL or 60 mL ... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Nalbuphine 10 mg/mL injection solution packaged in an amber glass injectable ... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Dihydroergotamine mesylate 1 mg/mL injection solution packaged in an amber gl... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Jul 31, 2014 CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx o... Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container clo... Class II Ben Venue Laboratories Inc
Jul 30, 2014 0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxte... Lack of Assurance of Sterility; complaints of mold in the overpouch Class II Baxter Healthcare Corp.
Jul 24, 2014 Epel 18 mg Estradiol Pellet, For In Office Use Only, For In Office Administra... Non-Sterility: The recalled lot failed sterility testing. Class I Physician Preferred Medical, LLC
Jul 18, 2014 All sterile products within expiry Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices t... Class II Unique Pharmaceutical, Ltd
Jul 18, 2014 N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133 Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense. Class I Unique Pharmaceutical, Ltd
Jul 10, 2014 LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers... Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of... Class I Hospira Inc.
Jun 27, 2014 fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable ba... Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because f... Class II Healix Infusion Therapy, Inc.
Jun 27, 2014 fentaNYL 1500 mcg/30 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG ... Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because f... Class II Healix Infusion Therapy, Inc.
Jun 27, 2014 fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag,... Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because f... Class II Healix Infusion Therapy, Inc.
Jun 27, 2014 fentaNYL 2750 mcg/55 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG, ... Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because f... Class II Healix Infusion Therapy, Inc.
Jun 27, 2014 fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chlori... Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because f... Class II Healix Infusion Therapy, Inc.
Jun 27, 2014 Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), ... Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing. Class II Hospira Inc.
Jun 25, 2014 Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Ph... Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold co... Class I Pharmacy Creations
Jun 6, 2014 Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/25... Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container... Class II Hospira Inc.
May 28, 2014 del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Ph... Non Sterility; microbial contamination identified as Aspergillus species Class I Central Admixture Pharmacy Services, Inc.
May 28, 2014 adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pha... Non Sterility; microbial contamination identified as Aspergillus species Class I Central Admixture Pharmacy Services, Inc.
May 28, 2014 PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services,... Non Sterility; microbial contamination identified as Aspergillus species Class I Central Admixture Pharmacy Services, Inc.
May 28, 2014 LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Servic... Non Sterility; microbial contamination identified as Aspergillus species Class I Central Admixture Pharmacy Services, Inc.
May 15, 2014 Pfizerpen (penicillin G) 24 MU/300 mL 0.9%NS, Trinity Care Solutions, 202-C S... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Ambisome 285 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Oca... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cefepime 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Oc... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Vancomycin 1.25 gm/250 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Vancomycin 750 mg/150mL D5W,Trinity Care Solutions, 202-C SW 17th Street, Oca... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Ceftriaxone 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street,... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cubicin 486 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Vancomycin 750 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Meropenem 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Ceftriaxone 1 gm/50 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Oca... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 ANA Kit, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, ... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cubicin 600 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Impipenem/Cilastin (Primaxin) 500 mg/100 mL 0.9%NS, Trinity Care Solutions, 2... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Normal Saline 10 mL/10 mL Syringe, Trinity Care Solutions, 202-C SW 17th Stre... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Desferal 2.5 gm/14 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th St... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Levofloxacin 750 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street,... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cubicin 444 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Nafcillin 12 gm/300 mL, Trinity Care Solutions, 202-C SW 17th Street, Ocala, ... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cubicin 700 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cefepime 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cubicin 543 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions

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.