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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 17,141–17,160 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01

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

Ryddex G Tablets, Decongestant, Expectorant, 100 count bottle, OTC, Centurion Labs, LLC 657 Hwy 40 South, Ste B, Richland, MS 39218, NDC 23359-024-10

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

AMBI 40PSE/400GFN, 100 tablet bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0408-01

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

AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01

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

AMBI 3BRM/30DM/50PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0229-16

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

AMBI 3BRM/15DM/30PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0230-16.

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

AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16.

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

AMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0221-16.

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

AMBI 12.5 CPD/120GFN/5PEH, Cough Suppressant, Expectorant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0224-16

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

AMBI 12.5 CPD/100GFN/30PSE, Antitussive, Expectorant, Nasal Decongestant, Raspberry Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0223-16

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

AMBI 25DPH/7.5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0226-16

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

AMBI 20DM100GFN10PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-16

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

AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 4 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-04

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

DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-32

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
Recall initiated
April 30, 2013
Reported by FDA
June 12, 2013
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12

by Hospira Inc.

Reason
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Recall initiated
May 16, 2013
Reported by FDA
June 12, 2013
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. Made in India

by Mylan Pharmaceuticals Inc.

Reason
Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets..
Recall initiated
April 22, 2013
Reported by FDA
June 5, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Camila 0.35 mg Tablets, 6 cards of 28 pills, Dist. By: Physicians Total Care, Tulsa, OK --- NDC 54868-4814-0, MFG By TEVA Pharmaceuticals USA, Sellersville, PA

by Physicians Total Care, Inc.

Reason
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Recall initiated
March 18, 2013
Reported by FDA
June 5, 2013
Distribution
MO

View recall →

Drug Recall Terminated Historical recordClass III

Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad- 500 072 India

by Aurobindo Pharma USA Inc

Reason
Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label
Recall initiated
April 9, 2013
Reported by FDA
June 5, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and Ethinyl Estradiol 0.01 Tablets, 2 Extended-Cycle Tablet Dispensers (NDC 0093-3134-82) and 1 Extended-Cycle Tablet Dispenser NDC 0093-3134-91), 91 Tablets Each, Rx only, TEVA Womens Health Inc., Subsidiary of TEVA Pharmaceuticals, Inc., Sellersville, PA

by Teva Pharmaceuticals USA, Inc.

Reason
Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Recall initiated
March 14, 2013
Reported by FDA
June 5, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91 tablets each, Rx only, TEVA Women Health, Inc., Subsidiary of TEVA Pharmaceuticals USA, Inc., Sellersville, PA NDC 51285-058-66

by Teva Pharmaceuticals USA, Inc.

Reason
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) detected during impurity testing
Recall initiated
March 14, 2013
Reported by FDA
June 5, 2013
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.