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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 17,101–17,120 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

by THE COMPOUNDING SHOP, INC.

Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated
May 2, 2013
Reported by FDA
June 12, 2013
Distribution
Florida, California, Minnesota, and Maine

View recall →

Drug Recall Terminated Historical recordClass II

Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

by THE COMPOUNDING SHOP, INC.

Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated
May 2, 2013
Reported by FDA
June 12, 2013
Distribution
Florida, California, Minnesota, and Maine

View recall →

Drug Recall Terminated Historical recordClass II

Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

by THE COMPOUNDING SHOP, INC.

Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated
May 2, 2013
Reported by FDA
June 12, 2013
Distribution
Florida, California, Minnesota, and Maine

View recall →

Drug Recall Terminated Historical recordClass II

Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL

by THE COMPOUNDING SHOP, INC.

Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recall initiated
May 2, 2013
Reported by FDA
June 12, 2013
Distribution
Florida, California, Minnesota, and Maine

View recall →

Drug Recall Terminated Historical recordClass II

Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL

by THE COMPOUNDING SHOP, INC.

Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Recall initiated
May 2, 2013
Reported by FDA
June 12, 2013
Distribution
Florida, California, Minnesota, and Maine

View recall →

Drug Recall Terminated Historical recordClass II

Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL

by THE COMPOUNDING SHOP, INC.

Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Recall initiated
May 2, 2013
Reported by FDA
June 12, 2013
Distribution
Florida, California, Minnesota, and Maine

View recall →

Drug Recall Terminated Historical recordClass II

Avastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL

by THE COMPOUNDING SHOP, INC.

Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Recall initiated
May 2, 2013
Reported by FDA
June 12, 2013
Distribution
Florida, California, Minnesota, and Maine

View recall →

Drug Recall Terminated Historical recordClass II

Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL

by THE COMPOUNDING SHOP, INC.

Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Recall initiated
May 2, 2013
Reported by FDA
June 12, 2013
Distribution
Florida, California, Minnesota, and Maine

View recall →

Drug Recall Terminated Historical recordClass II

Metronidazole Tablets, USP, 500 mg, packaged in a) 10-count tablets per bottle (NDC 54868-0158-3); b) 14-count tablets per bottle (NDC 54868-0158-1); c) 20-count tablets per bottle (NDC 54868-0158-5); d) 21-count tablets per bottle (NDC 54868-0158-0); e) 30-count tablets per bottle (NDC 54868-0158-8), Rx only, Mfg. By: Pliva Krakow Pharma. Comp., Krakow, Poland; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146.

by Physicians Total Care, Inc.

Reason
Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.
Recall initiated
April 6, 2011
Reported by FDA
June 12, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0073-16

by TG United, Inc.

Reason
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated
January 30, 2013
Reported by FDA
June 12, 2013
Distribution
FL, MS, SC, LA and TX

View recall →

Drug Recall Terminated Historical recordClass II

ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0080-30

by TG United, Inc.

Reason
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated
January 30, 2013
Reported by FDA
June 12, 2013
Distribution
FL, MS, SC, LA and TX

View recall →

Drug Recall Terminated Historical recordClass II

Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0002-16

by TG United, Inc.

Reason
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated
January 30, 2013
Reported by FDA
June 12, 2013
Distribution
FL, MS, SC, LA and TX

View recall →

Drug Recall Terminated Historical recordClass II

Z-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0001-30

by TG United, Inc.

Reason
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated
January 30, 2013
Reported by FDA
June 12, 2013
Distribution
FL, MS, SC, LA and TX

View recall →

Drug Recall Terminated Historical recordClass II

Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0082-30

by TG United, Inc.

Reason
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated
January 30, 2013
Reported by FDA
June 12, 2013
Distribution
FL, MS, SC, LA and TX

View recall →

Drug Recall Terminated Historical recordClass II

Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ, 08872, NDC 13811-0081-30

by TG United, Inc.

Reason
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated
January 30, 2013
Reported by FDA
June 12, 2013
Distribution
FL, MS, SC, LA and TX

View recall →

Drug Recall Terminated Historical recordClass II

Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-088-16

by TG United, Inc.

Reason
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated
January 30, 2013
Reported by FDA
June 12, 2013
Distribution
FL, MS, SC, LA and TX

View recall →

Drug Recall Terminated Historical recordClass II

TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-083-30

by TG United, Inc.

Reason
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated
January 30, 2013
Reported by FDA
June 12, 2013
Distribution
FL, MS, SC, LA and TX

View recall →

Drug Recall Terminated Historical recordClass II

TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-068-16

by TG United, Inc.

Reason
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated
January 30, 2013
Reported by FDA
June 12, 2013
Distribution
FL, MS, SC, LA and TX

View recall →

Drug Recall Terminated Historical recordClass II

TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-067-16

by TG United, Inc.

Reason
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated
January 30, 2013
Reported by FDA
June 12, 2013
Distribution
FL, MS, SC, LA and TX

View recall →

Drug Recall Terminated Historical recordClass II

Mesehist WC, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0075-16

by TG United, Inc.

Reason
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated
January 30, 2013
Reported by FDA
June 12, 2013
Distribution
FL, MS, SC, LA and TX

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.