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Browse Drug Recalls

52 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 52 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 52 FDA drug recalls.

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DateProductReasonClassFirm
Jul 14, 2017 Ephedrine Sulfate in 0.9% Sodium Chloride 10 mL, 50 mg/10 mL (5 mg/mL) Single... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Norepinephrine Bitartrate 4 mg Added to 0.9% Sodium Chloride 250 mL (16 mcg ... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantre... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL (32 mcg p... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Adenosine in 0.9% Sodium Chloride 30mL, 90 mg/30 mL (3 mg/mL) Single-Dose Syr... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Glycopyrrolate Injection Solution, 2 mL 0.4 mg/2 mL (0.2 mg/mL) Single-Dose S... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL (64 mcg ... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Succinylcholine Chloride Injection Solution 5 mL, 100 mg/5 mL (20 mg/mL) Sing... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Ephedrine Sulfate Injection Solution 1 mL, 50 mg/1 mL (50 mg/mL) Single-Dose... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Succinylcholine Chloride Injection Solution 10 mL, 200 mg/10 mL (20 mg/mL) Si... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Sodium Bicarbonate 8.4% Injection Solution 50 mL, 50 mEq (1mEq/mL) Single-Dos... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 25 mg/5 mL (5 mg/mL) Single-D... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Glycopyrrolate Injection Solution, 1 mL 0.2 mg/1 mL (0.2 mg/mL) Single-Dose S... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Rocuronium Bromide Injection Solution 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Neostigmine Methylsulfate Injection Solution 5 mL, 5 mg/5 mL (1 mg/mL) Single... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Glycopyrrolate Injection Solution, 5 mL 1 mg/5 mL (0.2 mg/mL) Single-Dose Syr... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 50 mg/5 mL (10 mg/mL) Single... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Phenylephrine HCL in 0.9% Sodium Chloride 10 mL, 1 mg/10 mL (100 mcg/mL) Sing... Lack of Sterility Assurance. Class II Cantrell Drug Company
Nov 18, 2016 Calcium Chloride 1 g/50 mL* Added to 5% Dextrose (20 mg/mL)*, Single-Dose Bag... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride, 100 mL Bag, Single-Dose Bag... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Phenylephrine HCl 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL Sing... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial (1 mg/mL), S... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Midazolam HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL), Single-Dose Syri... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride, 1... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Rocuronium Bromide 50 mg/5 mL Injection Solution, 5 mL (10 mg/mL) Single-Dose... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Neostigmine Methylsulfate 5 mg/5 mL Injection Solution, 5 mL (1 mg/mL) Single... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Glycopyrrolate 1 mg/5 mL (0.2 mg/mL) Injection Solution, 5 mL Single-Dose Syr... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Heparin Sodium 5,000 USP Units Added to 0.9% Sodium Chloride 1,000 mL* Bag (5... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Calcium Chloride (20 mg/mL) in 0.9% Sodium Chloride 500 mL Bag, Rx Only, Sing... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Succinylcholine Chloride 200 mg/10 mL Injection Solution 10 mL (20 mg/mL) ,Si... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Ropivacaine HCl 0.25% in 0.9% Sodium Chloride, 100 mL Bag, Epidural Use Only,... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride (0.2 mg/mL) Single-Dose ... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Fentanyl Citrate 1,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 150 mL Bag, Si... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Heparin Sodium, 1 USP Unit/2 mL (0.5 USP Units/mL) in 0.45% Sodium Chloride, ... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Fentanyl Citrate 2,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 250 mL* Bag, S... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 HYDROmorphone HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL) Single-Dose S... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Calcium Chloride, (1 g/10 mL) Injection Solution 10 mL, 10% Single-Dose Vial,... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Oxytocin 30 USP Units Added to 0.9% Sodium Chloride, 500 mL Bag, Single-Dose ... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Lidocaine HCl 1%, 10 mL Syringe, Hospital/Office Use Only, Rx Only, Cantrell ... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Aug 21, 2015 MIDAZolam HCl 0.1 mg/mL in 5% DEXTROSE 2.5 mL syringe, Rx Only, Cantrell Drug... Subpotent Drug Class II Cantrell Drug Company
Aug 21, 2015 fentaNYL Citrate 1 MCG/mL in 0.9% Sodium Chloride Injection, in 3 mL Syringe,... Subpotent Drug Class I Cantrell Drug Company
Aug 21, 2015 HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE, in 3 mL Syringe, R... Stability Data Does Not Support Expiry Class II Cantrell Drug Company
Aug 21, 2015 Atropine Sulfate Injection Solution, 0.4 mg/1 mL (0.4 mg/mL), in a) 1 mL syr... Subpotent Drug Class I Cantrell Drug Company
Aug 21, 2015 LIDocaine HCl 1% BUFFERED WITH SODIUM BICARBONATE Injection, packaged in 3 mL... Subpotent Drug Class II Cantrell Drug Company
Aug 21, 2015 Midazolam HCl in 0.9% Sodium Chloride Injection, 0.5 mg/mL 1 mL (0.5 mg/mL), ... Subpotent Drug Class II Cantrell Drug Company
Aug 21, 2015 MIDAZOLAM HCl in 0.9% Sodium Chloride Injection, 2 mg/2 mL (1 mg/mL), in 2 mL... Subpotent Drug Class II Cantrell Drug Company
Aug 21, 2015 fentaNYL citrate in 0.9% Sodium Chloride Injection, 10 mcg/1 mL (10 mcg/mL), ... Subpotent Drug Class I Cantrell Drug Company
Aug 21, 2015 fentaNYL Citrate 50 mcg/mL in Sterile Water for Injection, packaged in 2 mL s... Subpotent Drug Class I Cantrell Drug Company
Aug 21, 2015 fentaNYL CITRATE 25 mcg/mL in 5% DEXTROSE Injection, in 2 mL Syringe, Rx Only... Subpotent Drug Class I Cantrell Drug Company
Aug 21, 2015 fentaNYL citrate in 0.9% Sodium Chloride Injection, 5 mcg/1 mL (5 mcg/mL), in... Subpotent Drug Class I Cantrell Drug 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.