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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 13,561–13,580 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Vancomycin 25 mg/mL Opthalmic Solution, packaged in a) 10 mL bottle and b) 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

by Liberty Drug & Surgical

Reason
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Recall initiated
June 15, 2015
Reported by FDA
September 2, 2015
Distribution
Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY

View recall →

Drug Recall Terminated Historical recordClass II

Papaverine/Phentolamine/PGE-1 Injectable, 20.8 mg/1.4 mg/14 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

by Liberty Drug & Surgical

Reason
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Recall initiated
June 15, 2015
Reported by FDA
September 2, 2015
Distribution
Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY

View recall →

Drug Recall Terminated Historical recordClass II

Papaverine/Phentolamine/PGE-1 Injectable, 10 mg/0.6 mg/10 mcg/mL, 2.5 mL vials, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

by Liberty Drug & Surgical

Reason
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Recall initiated
June 15, 2015
Reported by FDA
September 2, 2015
Distribution
Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY

View recall →

Drug Recall Terminated Historical recordClass II

Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/2 mg/20 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

by Liberty Drug & Surgical

Reason
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Recall initiated
June 15, 2015
Reported by FDA
September 2, 2015
Distribution
Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY

View recall →

Drug Recall Terminated Historical recordClass II

Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 9 mg/1 mg/0.1 mg/10 mcg/mL, 2 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

by Liberty Drug & Surgical

Reason
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Recall initiated
June 15, 2015
Reported by FDA
September 2, 2015
Distribution
Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY

View recall →

Drug Recall Terminated Historical recordClass II

Methylcobalamin 5000 mcg/mL Injectable, 2 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

by Liberty Drug & Surgical

Reason
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Recall initiated
June 15, 2015
Reported by FDA
September 2, 2015
Distribution
Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY

View recall →

Drug Recall Terminated Historical recordClass II

Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/1 mg/10 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

by Liberty Drug & Surgical

Reason
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Recall initiated
June 15, 2015
Reported by FDA
September 2, 2015
Distribution
Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY

View recall →

Drug Recall Terminated Historical recordClass II

Cyanocobalamin 500 mcg/mL Injectable, 1 mL pre-filled syringe, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

by Liberty Drug & Surgical

Reason
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Recall initiated
June 15, 2015
Reported by FDA
September 2, 2015
Distribution
Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY

View recall →

Drug Recall Terminated Historical recordClass III

Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-313-30.

by Dr. Reddy's Laboratories, Inc.

Reason
Subpotent Drug: Subpotent atorvastatin.
Recall initiated
August 13, 2015
Reported by FDA
September 2, 2015
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90 Count Bottles (NDC: 43598-315-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India.

by Dr. Reddy's Laboratories, Inc.

Reason
Subpotent Drug: Subpotent atorvastatin.
Recall initiated
August 13, 2015
Reported by FDA
September 2, 2015
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-318-30) and b) 90 Count Bottles (NDC: 43598-318-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India

by Dr. Reddy's Laboratories, Inc.

Reason
Subpotent Drug: Subpotent atorvastatin.
Recall initiated
August 13, 2015
Reported by FDA
September 2, 2015
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-319-30) and b) 90 Count Bottles (NDC: 43598-319-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India.

by Dr. Reddy's Laboratories, Inc.

Reason
Subpotent Drug: Subpotent atorvastatin.
Recall initiated
August 13, 2015
Reported by FDA
September 2, 2015
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Amlodipine besylate and Atorvastatin calcium Tablets,2.5 mg/40 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-317-30.

by Dr. Reddy's Laboratories, Inc.

Reason
Subpotent Drug: Subpotent atorvastatin.
Recall initiated
August 13, 2015
Reported by FDA
September 2, 2015
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/20 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-320-30.

by Dr. Reddy's Laboratories, Inc.

Reason
Subpotent Drug: Subpotent atorvastatin.
Recall initiated
August 13, 2015
Reported by FDA
September 2, 2015
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/10 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-323-30.

by Dr. Reddy's Laboratories, Inc.

Reason
Subpotent Drug: Subpotent atorvastatin.
Recall initiated
August 13, 2015
Reported by FDA
September 2, 2015
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-count bottle (NDC 10702-0026-10; UPC 3 10702 02601 0); Rx only, Mfd. by KVK-TECH, Inc., Newtown, PA

by KVK-Tech, Inc.

Reason
Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Recall initiated
July 14, 2015
Reported by FDA
September 2, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada, L6T 1C1, Dist by: TaroPharma, Hawthorne, NY 10532. NDC: 51672-5281-7.

by Taro Pharmaceuticals, Inc.

Reason
Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.
Recall initiated
August 5, 2015
Reported by FDA
September 2, 2015
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppressant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-019-66, UPC 63824-01966-9, UPC 63824-52622-5

by Reckitt Benckiser LLC

Reason
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Recall initiated
April 15, 2015
Reported by FDA
September 2, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6 fl oz (180 mL) bottles Total - 12 fl oz (360 mL), For Ages 12+, Dist. by Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-528-22-01, NDC 63824-528-22-00, UPC 63824-52822-9

by Reckitt Benckiser LLC

Reason
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Recall initiated
April 15, 2015
Reported by FDA
September 2, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-014-66, UPC 6382401465-4

by Reckitt Benckiser LLC

Reason
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Recall initiated
April 15, 2015
Reported by FDA
September 2, 2015
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.