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Browse Drug Recalls

14 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14 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 14 FDA drug recalls.

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DateProductReasonClassFirm
Feb 29, 2024 FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 m... Lack of Assurance of Sterility: Firm did not perform process validation. Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Feb 29, 2024 Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenou... Lack of Assurance of Sterility: Firm did not perform process validation. Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
May 9, 2023 HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), ... CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Sep 22, 2021 Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx O... Lack of Assurance of Sterility Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 10, 2017 HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Conce... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 10, 2017 Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 10, 2017 Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentratio... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 10, 2017 Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL, 10 mL syringe, Concentr... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 10, 2017 Succinylcholine chloride 100 mg in 5 mL syringe, Concentration: 20 mg/mL. Th... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 10, 2017 Neostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mL. T... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 10, 2017 Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mc... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 10, 2017 Morphine 50 mg in 0.9% Sodium Chloride 5 mL PCA, 50 mL Cartridge, Concentrati... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 10, 2017 Amiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1.8 mg/mL... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 10, 2017 Norepinephrine 8 mg in dextrose 5% 250 mL, 250mL IV Bag, Concentration: 0.032... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...

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.