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Browse Drug Recalls

166 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 166 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 166 FDA drug recalls.

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DateProductReasonClassFirm
May 18, 2017 fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total ... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volum... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Vo... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
May 18, 2017 ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g, Total ... Lack of assurance of sterility: Product bags leaking at seam. Class II SCA Pharmaceuticals
Feb 3, 2017 Vancomycin HCl 1.25 g added to 5% Dextrose 250 mL Bag For IV Use Only, Rx Onl... Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydr... Class I SCA Pharmaceuticals
Feb 3, 2017 Vancomycin HCl 1.5 gram added to 5% Dextrose 500 mL Total Approximate Volume ... Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydr... Class I SCA Pharmaceuticals
Feb 3, 2017 Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, ... Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydr... Class I SCA Pharmaceuticals
Feb 3, 2017 Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only, Rx Only, S... Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydr... Class I SCA Pharmaceuticals
Feb 3, 2017 Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only... Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydr... Class I SCA Pharmaceuticals
Feb 3, 2017 Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Onl... Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydr... Class I SCA Pharmaceuticals
Feb 3, 2017 Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only, R... Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydr... Class I SCA Pharmaceuticals
Apr 28, 2015 PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag (Concentration = 0... Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chlo... Class II SCA Pharmaceuticals
Feb 24, 2015 Droperidol injection, 2.5 mg/mL, 5 mg Total Dose, 2 mL Fill Volume per syring... Presence of particulate. Class II SCA Pharmaceuticals
Jan 2, 2015 Glycopyrrolate injection, 0.2 mg per mL (1 mg/5 mL), 5 mL Fill in 10 mL Syrin... Labeling: Incorrect or missing Lot and/or Exp Date: Printing error caused an overlap in the "y" a... Class II SCA Pharmaceuticals

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.