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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.