Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Drug Recalls

291 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 291 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 291 FDA drug recalls.

Clear
DateProductReasonClassFirm
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL i... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection, 9 mMol in 100 mL in 15... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7 mMol in 100 mL in 15... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Apr 6, 2017 Fentanyl Citrate (Preservative Free) 20 mcg per mL (2,000 mcg per 100 mL) 100... Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expira... Class II PharMedium Services, Llc
Apr 6, 2017 Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100... Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expira... 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 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, 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 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 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 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, 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 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 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 1.5g 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 mMol 100 mL Bag, Service... Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. 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 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 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 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 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
Jan 27, 2017 Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 ... Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of... Class III Pharmedium Services, LLC
Oct 12, 2016 Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx onl... Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the fir... Class II Pharmedium Services, LLC
May 16, 2016 Potassium CHLORide added to 5% Dextrose Injection, 20 mEq 250 mL Bag, PharMED... Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label s... Class II Pharmedium Services, LLC
May 5, 2016 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) in ... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2 mcg/mL Fentanyl Citrate and 0.167% Bupivacaine HCl (Preservative Free) in 0... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 10 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in 0.... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) i... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 1 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 0.03% Bupivacaine HCl (Preservative Free) in Sodium Chloride 0.9%, 250 mL Me... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 10 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 20 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2.5 mcg/mL Fentanyl Citrate and 0.15% Bupivacaine HCl (Preservative Free) in ... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2.5 mcg/mL Fentanyl Citrate and 0.0312% Bupivacaine HCl (Preservative Free) i... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2.5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2.5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) i... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in ... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 0.5% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 2... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) in ... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, a) 250 m... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in ... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) i... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC

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.