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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 5,561–5,580 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004030022

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recall initiated
December 17, 2020
Reported by FDA
January 13, 2021
Distribution
Product was distributed to hospitals nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recall initiated
December 17, 2020
Reported by FDA
January 13, 2021
Distribution
Product was distributed to hospitals nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals 8521 Knoedl Ct., Little Rock, AR, 72205, barcode 70004060409

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recall initiated
December 17, 2020
Reported by FDA
January 13, 2021
Distribution
Product was distributed to hospitals nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

SUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., WIndsor, CT, 06095, barcode 70004090809

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recall initiated
December 17, 2020
Reported by FDA
January 13, 2021
Distribution
Product was distributed to hospitals nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(barcode 7000485009) Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 and b) 5 mL Single Dose Syringe White Label (barcode 70004085028), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recall initiated
December 17, 2020
Reported by FDA
January 13, 2021
Distribution
Product was distributed to hospitals nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081011

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recall initiated
December 17, 2020
Reported by FDA
January 13, 2021
Distribution
Product was distributed to hospitals nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010016

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recall initiated
December 17, 2020
Reported by FDA
January 13, 2021
Distribution
Product was distributed to hospitals nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

SUCccinylcholine Chloride 200 mg/10 mL, (20 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090812

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recall initiated
December 17, 2020
Reported by FDA
January 13, 2021
Distribution
Product was distributed to hospitals nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090025

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recall initiated
December 17, 2020
Reported by FDA
January 13, 2021
Distribution
Product was distributed to hospitals nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Rocuronium Br 100 mg/10mL (10 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR, 72205, barcode 70004085012

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recall initiated
December 17, 2020
Reported by FDA
January 13, 2021
Distribution
Product was distributed to hospitals nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride (80 mcg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081612

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recall initiated
December 17, 2020
Reported by FDA
January 13, 2021
Distribution
Product was distributed to hospitals nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081012

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recall initiated
December 17, 2020
Reported by FDA
January 13, 2021
Distribution
Product was distributed to hospitals nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

neostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004075009

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recall initiated
December 17, 2020
Reported by FDA
January 13, 2021
Distribution
Product was distributed to hospitals nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010316

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recall initiated
December 17, 2020
Reported by FDA
January 13, 2021
Distribution
Product was distributed to hospitals nationwide.

View recall →

Drug Recall Terminated Historical recordClass III

Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 ml Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010025

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recall initiated
December 17, 2020
Reported by FDA
January 13, 2021
Distribution
Product was distributed to hospitals nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Lidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072309

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recall initiated
December 17, 2020
Reported by FDA
January 13, 2021
Distribution
Product was distributed to hospitals nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pharma, Inc., 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072012

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recall initiated
December 17, 2020
Reported by FDA
January 13, 2021
Distribution
Product was distributed to hospitals nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004070028

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recall initiated
December 17, 2020
Reported by FDA
January 13, 2021
Distribution
Product was distributed to hospitals nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043012

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recall initiated
December 17, 2020
Reported by FDA
January 13, 2021
Distribution
Product was distributed to hospitals nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (barcode 70004030316) and b) 30 mL Single Dose Syringe (barcode 70004030321), Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recall initiated
December 17, 2020
Reported by FDA
January 13, 2021
Distribution
Product was distributed to hospitals nationwide.

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.