Browse Drug Recalls

1,141 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,141 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 1,141 FDA drug recalls in 2017.

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DateProductReasonClassFirm
Feb 22, 2017 Methohexital Sodium all strengths, all dosage forms and all packaging, Rx On... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Sufentanil Citrate all strengths, all dosage forms and all packaging, Rx Onl... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Sodium Phosphate all strengths, all dosage forms and all packaging, Rx Only,... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Gentamicin Sulfate all strengths, all dosage forms and all packaging, Rx Onl... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Early TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx O... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Fentanyl Citrate all strengths, all dosage forms and all packaging, Rx Only,... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Dexamethasone Sodium Phosphate all strengths, all dosage forms and all packag... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 NICU STARTER TPN all strengths, all dosage forms and all packaging, Rx Only,... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Bumetadine all strengths, all dosage forms and all packaging, Rx Only, Avell... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not f... Chemical Contamination Class III Novel Laboratories, Inc.
Feb 22, 2017 Cefazolin all strengths, all dosage forms and all packaging, Rx Only, Avella... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Early Baby TPN (Neonatal) all strengths, all dosage forms and all packaging, ... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Glycopyrrolate all strengths, all dosage forms and all packaging, Rx Only, Av... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Lorazepam HCl all strengths, all dosage forms and all packaging, Rx Only, Av... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Phenylephrine HCl all strengths, all dosage forms and all packaging, Rx Only... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Vancomycin HCl all strengths, all dosage forms and all packaging, Rx Only, A... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Nicardipine HCl all strengths, all dosage forms and all packaging, Rx Only, ... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 22, 2017 Oxytocin all strengths, all dosage forms and all packaging, Rx Only, Avella ... Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex. Class II Advanced Pharma Inc.
Feb 21, 2017 A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%, Packaged in a) ... Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a label... Class III Bayer HealthCare Pharmaceuticals, Inc.
Feb 17, 2017 Potassium PHOSphate added to 0.9% Sodium Chloride, 7 mMol 100 mL Bag, Service... Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. Class III Pharmedium Services, LLC
Feb 17, 2017 VANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP, Service Code 2K2227,... Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. Class II Pharmedium Services, LLC
Feb 17, 2017 Potassium PHOSphate added to 0.9% Sodium Chloride, 7.5 mMol 100 mL Bag, Servi... Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. Class III Pharmedium Services, LLC
Feb 17, 2017 VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP, Service Co... Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. Class II Pharmedium Services, LLC
Feb 17, 2017 Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per ... Failed Dissolution Specifications: low out of specification dissolution results found during stab... Class III Teva Pharmaceuticals USA
Feb 17, 2017 Potassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service C... Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. Class III Pharmedium Services, LLC
Feb 17, 2017 Potassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag, Servic... Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. Class III Pharmedium Services, LLC
Feb 17, 2017 Potassium CHLORide added to 0.9% Sodium Chloride, 10mEq 100 mL Bag, Service C... Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. Class III Pharmedium Services, LLC
Feb 17, 2017 Potassium PHOSphate in 0.5% Dextrose, 7.5 mMol in 100 mL, Service Code 2K5299... Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. Class II Pharmedium Services, LLC
Feb 17, 2017 Potassium PHOSphate added to 0.9% Sodium Chloride, 15 mMol 100 mL Bag, Servic... Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. Class III Pharmedium Services, LLC
Feb 17, 2017 VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP, Service Cod... Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. Class II Pharmedium Services, LLC
Feb 17, 2017 Potassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag, Servic... Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. Class III Pharmedium Services, LLC
Feb 16, 2017 HealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable Tablets,... cGMP deviations - presence of rubber particles found loose in the bulk product. Class II Allegiant Health
Feb 16, 2017 Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15... Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring enviro... Class II Sato Pharmaceutical Inc.
Feb 16, 2017 XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg ... Marketed without an Approved NDA/ANDA: Product contains N-desmethyl tadalafil an analogue to tada... Class I Organic Herbal Supply
Feb 16, 2017 DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL)... Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring enviro... Class II Sato Pharmaceutical Inc.
Feb 16, 2017 SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged i... Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring enviro... Class II Sato Pharmaceutical Inc.
Feb 15, 2017 Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 1... Failed dissolution specifications - low dissolution results at S3 stage. Class III Dr. Reddy's Laboratories, Inc.
Feb 15, 2017 Ropivacaine HCl 0.2% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlor... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Pharmedium Services Llc
Feb 15, 2017 Zenatane (isotretinoin) capsules, 30 mg, packaged in 30-count cartons (3 x 1... Failed dissolution specifications - low dissolution results at S3 stage. Class III Dr. Reddy's Laboratories, Inc.
Feb 15, 2017 Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlor... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Pharmedium Services Llc
Feb 15, 2017 Ropivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlor... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Pharmedium Services Llc
Feb 15, 2017 Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlor... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Pharmedium Services Llc
Feb 15, 2017 Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlo... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Pharmedium Services Llc
Feb 15, 2017 Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 1... Failed dissolution specifications - low dissolution results at S3 stage. Class III Dr. Reddy's Laboratories, Inc.
Feb 15, 2017 Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlo... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Pharmedium Services Llc
Feb 15, 2017 Ropivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in 0.9% Sodium ... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Pharmedium Services Llc
Feb 15, 2017 Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only,... Failed impurities/ degradation specifications: Product was above specification for unknown impuri... Class II AVKARE Inc.
Feb 15, 2017 Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 1... Failed dissolution specifications - low dissolution results at S3 stage. Class III Dr. Reddy's Laboratories, Inc.
Feb 13, 2017 Salicylic Acid Cream, 6%, 400g bottle, Rx Only, Manufactured By Perrigo Yeruh... Failed Impurities/Degradation Specifications: The API for these products had an out of specificat... Class III L. Perrigo Company
Feb 13, 2017 Salicylic Acid Shampoo, 6%, 177 mL bottle, Rx only, Manufactured By Perrigo Y... Failed Impurities/Degradation Specifications: The API for these products had an out of specificat... Class III L. Perrigo Company

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.