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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 10,521–10,540 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass III

Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per carton, Rx only, Mfd. for: Watson Laboratories, Inc., Corona, CA 92880; Mfd. by: Cipla Ltd., Verna, Goa INDIA, NDC 0591-3467-53.

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
Recall initiated
July 25, 2017
Reported by FDA
August 9, 2017
Distribution
Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA; Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
Recall initiated
July 11, 2017
Reported by FDA
August 9, 2017
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59.

by Precision Dose Inc.

Reason
Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
Recall initiated
July 5, 2017
Reported by FDA
August 9, 2017
Distribution
OH and CT

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Drug Recall Terminated Historical recordClass II

Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, Rx Only, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0190-15

by Apace KY LLC

Reason
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Recall initiated
June 19, 2017
Reported by FDA
August 9, 2017
Distribution
KY

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Drug Recall Terminated Historical recordClass II

Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0069-15

by Apace KY LLC

Reason
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Recall initiated
June 19, 2017
Reported by FDA
August 9, 2017
Distribution
KY

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Drug Recall Terminated Historical recordClass II

Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0833-40

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

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Drug Recall Terminated Historical recordClass II

Potassium Chloride 20 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0832-40

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

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Drug Recall Terminated Historical recordClass II

PHENYLephrine 100 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 882PHENYLephrine 100 mg 1 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0813-40

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

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Drug Recall Terminated Historical recordClass II

PHENYLephrine 10 mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0811-59

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

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Drug Recall Terminated Historical recordClass II

PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride 250 mL Bag, Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0811-40

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

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Drug Recall Terminated Historical recordClass II

PHENYLephrine HCl 25 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0810-40

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

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Drug Recall Terminated Historical recordClass II

NORepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0775-40

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

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Drug Recall Terminated Historical recordClass II

NORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0774-40

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

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Drug Recall Terminated Historical recordClass II

NORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0771-40

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

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Drug Recall Terminated Historical recordClass II

EPINEPHrine HCl 4 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0613-40

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

ePHEDrine Sulfate 5 mg/mL in NS 5 mL Fill in 12 mL Syringe (25 mg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0600-11

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

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Drug Recall Terminated Historical recordClass II

fentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0290-40

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 Sodium Chloride 250 mL (Total Dose=2500 mcg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-40

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 0.9% Sodium Chloride 1 mL in Single Dose syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0225-24

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 0.2% IN 0.9% Sodium Chloride 250 mL Bag Preservative Free (Total Dose Bupivacaine 500 mg per 250 mL), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0066-40

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 →

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.