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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
Nov 9, 2023 fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 m... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS U... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentrat... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 ... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentrat... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentratio... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag,... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentratio... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 m... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentr... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 m... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/m... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentrati... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentra... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey ... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentra... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 4... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = ... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = ... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentra... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentratio... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL ... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 1... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentrati... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentr... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Jul 20, 2023 FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL ... cGMP deviations: due to shipment of rejected units. Class II SCA Pharmaceuticals
Apr 10, 2023 Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose ... Subpotent Drug: Out of specification results for low potency was obtained. Class III SCA Pharmaceuticals
Feb 24, 2023 Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentratio... Subpotent Drug Class III SCA Pharmaceuticals
Apr 25, 2022 Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, ... CGMP Deviations Class II SCA Pharmaceuticals
Apr 25, 2022 Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceu... CGMP Deviations Class II SCA Pharmaceuticals
Apr 25, 2022 Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharm... CGMP Deviations Class II SCA Pharmaceuticals
Dec 17, 2020 Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Onl... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride (80 mcg/mL), Rx Only,... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(bar... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 SUCccinylcholine Chloride 200 mg/10 mL, (20 mg/mL), Rx Only, 10 mL Single Dos... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Buffered Lidocaine HCl, 1%, 5 mL (10mg/mL) with Sodium Bicarbonate Injection ... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Rocuronium Br 100 mg/10mL (10 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, ... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 m... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class III SCA Pharmaceuticals
Dec 17, 2020 fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 5... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... 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.