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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 2,821–2,840 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7596-3), b) 60-count bottle (NDC68788-7596-6); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL.

by Preferred Pharmaceuticals, Inc.

Reason
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Recall initiated
March 27, 2023
Reported by FDA
April 12, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7595-3), b) 60-count bottle (NDC 68788-7595-6), c) 90-count bottle (NDC 68788-7595-9); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL.

by Preferred Pharmaceuticals, Inc.

Reason
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Recall initiated
March 27, 2023
Reported by FDA
April 12, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL. Ins:NDC 68788-7594-3

by Preferred Pharmaceuticals, Inc.

Reason
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Recall initiated
March 27, 2023
Reported by FDA
April 12, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701

by RemedyRePack Inc.

Reason
cGMP Deviations
Recall initiated
March 20, 2023
Reported by FDA
April 12, 2023
Distribution
RemedyRepack distributed product to consignees nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.

by RemedyRePack Inc.

Reason
cGMP Deviations
Recall initiated
March 20, 2023
Reported by FDA
April 12, 2023
Distribution
RemedyRepack distributed product to consignees nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles (NDC 70518-0375-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.

by RemedyRePack Inc.

Reason
cGMP Deviations
Recall initiated
March 20, 2023
Reported by FDA
April 12, 2023
Distribution
RemedyRepack distributed product to consignees nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00

by RemedyRePack Inc.

Reason
cGMP Deviations
Recall initiated
March 20, 2023
Reported by FDA
April 12, 2023
Distribution
RemedyRepack distributed product to consignees nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC70518-2750-00

by RemedyRePack Inc.

Reason
cGMP Deviations
Recall initiated
March 20, 2023
Reported by FDA
April 12, 2023
Distribution
RemedyRepack distributed product to consignees nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70518-1977-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.

by RemedyRePack Inc.

Reason
cGMP Deviations
Recall initiated
March 20, 2023
Reported by FDA
April 12, 2023
Distribution
RemedyRepack distributed product to consignees nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00

by RemedyRePack Inc.

Reason
cGMP Deviations
Recall initiated
March 20, 2023
Reported by FDA
April 12, 2023
Distribution
RemedyRepack distributed product to consignees nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701

by RemedyRePack Inc.

Reason
cGMP Deviations
Recall initiated
March 20, 2023
Reported by FDA
April 12, 2023
Distribution
RemedyRepack distributed product to consignees nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519-00.

by RemedyRePack Inc.

Reason
cGMP Deviations
Recall initiated
March 20, 2023
Reported by FDA
April 12, 2023
Distribution
RemedyRepack distributed product to consignees nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2439-00.

by RemedyRePack Inc.

Reason
cGMP Deviations
Recall initiated
March 20, 2023
Reported by FDA
April 12, 2023
Distribution
RemedyRepack distributed product to consignees nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-0405-00) and c)180-count bottles (NDC 70518-0405-02), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701

by RemedyRePack Inc.

Reason
cGMP Deviations
Recall initiated
March 20, 2023
Reported by FDA
April 12, 2023
Distribution
RemedyRepack distributed product to consignees nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) 90-count bottles (NDC 70518-1560-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.

by RemedyRePack Inc.

Reason
cGMP Deviations
Recall initiated
March 20, 2023
Reported by FDA
April 12, 2023
Distribution
RemedyRepack distributed product to consignees nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.

by RemedyRePack Inc.

Reason
cGMP Deviations
Recall initiated
March 20, 2023
Reported by FDA
April 12, 2023
Distribution
RemedyRepack distributed product to consignees nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921-03

by RemedyRePack Inc.

Reason
cGMP Deviations
Recall initiated
March 20, 2023
Reported by FDA
April 12, 2023
Distribution
RemedyRepack distributed product to consignees nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL multiple-dose vials (NDC 52536-625-10) and b) 1 mL single dose vials (NDC 52536-625-01), Rx only, Mfd for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328.

by Azurity Pharmaceuticals, Inc.

Reason
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Recall initiated
February 15, 2023
Reported by FDA
April 12, 2023
Distribution
US Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60.

by Ascend Laboratories, LLC

Reason
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Recall initiated
March 14, 2023
Reported by FDA
April 5, 2023
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing Historical recordClass II

Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-474-60.

by Ascend Laboratories, LLC

Reason
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Recall initiated
March 14, 2023
Reported by FDA
April 5, 2023
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.