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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 10,541–10,560 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

BUPIVacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Preservative Free (Waste From 250 mL Bag), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0060-40

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; product has the potential to leak.
Recall initiated
July 14, 2017
Reported by FDA
August 2, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 mg per mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0810-32.

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Recall initiated
July 14, 2017
Reported by FDA
August 2, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

morphine sulfate 1 mg per mL in 0.9% Sodium Chloride, (Total morphine Dose 100 mg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, (877) 550-5059; labeled as a) NDC: 70004-0100-59; b) NDC: 70004-100-58.

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Recall initiated
July 14, 2017
Reported by FDA
August 2, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0260-40

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; product has the potential to leak.
Recall initiated
July 14, 2017
Reported by FDA
August 2, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLephrine 50 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0820-40

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; product has the potential to leak.
Recall initiated
July 14, 2017
Reported by FDA
August 2, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0816-40

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; product has the potential to leak.
Recall initiated
July 14, 2017
Reported by FDA
August 2, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLephrine 200 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0815-40

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; product has the potential to leak.
Recall initiated
July 14, 2017
Reported by FDA
August 2, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0812-40

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; product has the potential to leak.
Recall initiated
July 14, 2017
Reported by FDA
August 2, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

PHENYLephrine HCl 60 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0809-40

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; product has the potential to leak.
Recall initiated
July 14, 2017
Reported by FDA
August 2, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Hydromorphone 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Fill in 3 mL BD syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0302-05

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; product has the potential to leak.
Recall initiated
July 14, 2017
Reported by FDA
August 2, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL 2 mcg/mL + BUPIvacaine 0.125% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0254-40

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; product has the potential to leak.
Recall initiated
July 14, 2017
Reported by FDA
August 2, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL 2 mcg/mL + BUPIvacaine 0.1% PF in 0.9% NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0230-40

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; product has the potential to leak.
Recall initiated
July 14, 2017
Reported by FDA
August 2, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL 10 mcg/mL PF in NS 1 mL Fill in 3 mL syringe, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-05

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; product has the potential to leak.
Recall initiated
July 14, 2017
Reported by FDA
August 2, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL 2 mcg/mL+Bupivacaine 0.0625% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0226-40

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; product has the potential to leak.
Recall initiated
July 14, 2017
Reported by FDA
August 2, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0202-40

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; product has the potential to leak.
Recall initiated
July 14, 2017
Reported by FDA
August 2, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

fentaNYL (as citrate) 5 mcg/mL In 250 mL 0.9% Sodium Chloride Injection Bag (Total fentaNYL Dose 1250 mcg/ 250 mL), Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0201-40

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; product has the potential to leak.
Recall initiated
July 14, 2017
Reported by FDA
August 2, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

BUPIVacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag, Preservative Free (Total Dose Bupivacaine 312.5 mg per 250 mL), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0062-40

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility; product has the potential to leak.
Recall initiated
July 14, 2017
Reported by FDA
August 2, 2017
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0737-32.

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Recall initiated
July 14, 2017
Reported by FDA
August 2, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Diltiazem 125 mg in 0.9% Sodium Chloride, 1 mg per mL, Total Volume 125 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0541-35.

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Recall initiated
July 14, 2017
Reported by FDA
August 2, 2017
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

ceFAZolin 3 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 115 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0524-32.

by SCA Pharmaceuticals

Reason
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Recall initiated
July 14, 2017
Reported by FDA
August 2, 2017
Distribution
Nationwide in the USA

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.