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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.

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DateProductReasonClassFirm
Jul 14, 2017 NORepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 NORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA P... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 fentaNYL 10 mcg/mL PF in Sodium Chloride 250 mL (Total Dose=2500 mcg), Rx onl... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
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 Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA ... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
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 Potassium Chloride 20 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA ... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
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 BUPIVacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Pre... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
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 NORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA P... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 BUPIVacaine HCl 0.2% IN 0.9% Sodium Chloride 250 mL Bag Preservative Free (To... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
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 PHENYLephrine 10 mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmace... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 fentaNYL as citrate 5 mcg/mL in 0.9% Sodium Chloride 1 mL in Single Dose syri... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
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 5 mg/mL in NS 5 mL Fill in 12 mL Syringe (25 mg), Rx only, ... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
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 morphine sulfate 1 mg per mL in 0.9% Sodium Chloride, (Total morphine Dose 10... Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have t... Class II SCA Pharmaceuticals
Jul 14, 2017 PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride 250 mL Bag, Preservative Free... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate... Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have t... Class II SCA Pharmaceuticals
Jul 14, 2017 Hydromorphone 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Fill in 3 mL BD syringe,... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 fentaNYL 2 mcg/mL + BUPIvacaine 0.1% PF in 0.9% NS 250 mL, Rx only, SCA Pharm... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 PHENYLephrine 50 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceutic... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 fentaNYL 10 mcg/mL PF in NS 1 mL Fill in 3 mL syringe, Rx only, SCA Pharmaceu... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 fentaNYL 2 mcg/mL + BUPIvacaine 0.125% PF in 0.9% Sodium Chloride 250 mL, Rx ... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
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 ceFAZolin 3 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume ... Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have t... Class II SCA Pharmaceuticals
Jul 14, 2017 fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride, (Total fentaNYL... Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have t... Class II SCA Pharmaceuticals
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 BUPIVacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag, Preservative Free ... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 fentaNYL (as citrate) 5 mcg/mL In 250 mL 0.9% Sodium Chloride Injection Bag ... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 fentaNYL 2 mcg/mL+Bupivacaine 0.0625% PF in 0.9% Sodium Chloride 250 mL, Rx o... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
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 Diltiazem 125 mg in 0.9% Sodium Chloride, 1 mg per mL, Total Volume 125 mL Si... Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have t... Class II SCA Pharmaceuticals
Jul 14, 2017 PHENYLephrine 200 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuti... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceut... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride 250 mL Bag, Rx on... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
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 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmace... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 PHENYLephrine HCl 60 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmace... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
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
Jul 14, 2017 PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceutic... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 12, 2017 Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL... CGMP Deviations: Firm failed to control impurity for color change at the API stage. Class III Pfizer Inc.
Jul 12, 2017 Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass ... CGMP Deviations Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jul 12, 2017 Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlor... Crystallization with subpotent out of specification assay results for chlorhexidine. Class III Akorn Inc
Jul 12, 2017 Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose ... Crystallization with subpotent out of specification assay results for chlorhexidine. Class III Akorn Inc

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.