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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 6,321–6,340 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 8 tablets. [NDC: Brand] NDC Good Sense:0113-0852-51; NDC Walgreens 0363-0852-51

by Perrigo Company PLC

Reason
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recall initiated
October 23, 2019
Reported by FDA
March 25, 2020
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per bottle. [NDC: Brand] NDC H.E.B.: 37808-876-47; NDC Equate: 49035-876-47

by Perrigo Company PLC

Reason
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recall initiated
October 23, 2019
Reported by FDA
March 25, 2020
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. [NDC: Brand] NDC Health Mart: 62011-0283-2; NDC Major: 0904-6715-52; NDC Meijer: 41250-252-72; NDC Sunmark: 49348-136-12;

by Perrigo Company PLC

Reason
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recall initiated
October 23, 2019
Reported by FDA
March 25, 2020
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451

by Fresenius Medical Care Holdings, Inc.

Reason
CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
Recall initiated
March 5, 2020
Reported by FDA
March 25, 2020
Distribution
Product was distributed throughout the United States.

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Drug Recall Terminated Historical recordClass II

Daytrana (methylphenidate transdermal system) patches, Delivers 30 mg over 9 hours (3.3 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5555-3

by Noven Therapeutics, LLC

Reason
Defective Delivery System: Out of specification for mechanical peel and shear.
Recall initiated
March 2, 2020
Reported by FDA
March 25, 2020
Distribution
U.S.A. Nationwide

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Drug Recall Terminated Historical recordClass II

Daytrana (methylphenidate transdermal system) patches, Delivers 20 mg over 9 hours (2.2 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5554-3

by Noven Therapeutics, LLC

Reason
Defective Delivery System: Out of specification for mechanical peel and shear.
Recall initiated
March 2, 2020
Reported by FDA
March 25, 2020
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Daytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5552-3

by Noven Therapeutics, LLC

Reason
Defective Delivery System: Out of specification for mechanical peel and shear.
Recall initiated
March 2, 2020
Reported by FDA
March 25, 2020
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Bow & Arrow, Dietary Supplement, Libido Enhancer for Men, a) Four pack, b) Ten pack capsules per carton, Exclusively Manufactured by: Medicine Man Distribution, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783

by Med Man Distribution, Inc.

Reason
Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
Recall initiated
November 8, 2019
Reported by FDA
March 25, 2020
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31

by Par Pharmaceutical Inc.

Reason
Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
Recall initiated
March 4, 2020
Reported by FDA
March 25, 2020
Distribution
U.S.A. Nationwide

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Drug Recall Terminated Historical recordClass II

Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-616-50.

by Sun Pharmaceutical Industries, Inc.

Reason
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Recall initiated
March 13, 2020
Reported by FDA
March 25, 2020
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-615-01.

by Sun Pharmaceutical Industries, Inc.

Reason
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.
Recall initiated
March 13, 2020
Reported by FDA
March 25, 2020
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01

by Mylan Pharmaceuticals Inc.

Reason
Presence of particulate matter. presence of metal particles.
Recall initiated
March 9, 2020
Reported by FDA
March 25, 2020
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Lisinopril/HCTZ 20mg/12.5mg Tablet, QTY: 30 tablets per blister card, MFG: Lupin Pharma Baltimore, MD 21202, NDC 68180-0519-02 (Original NDC of 500 count bottle); 70518-0382-03 (Repackaged NDC for blister cards).

by RemedyRePack Inc.

Reason
Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product complaint where one of Lupin's Fenofibrate 145mg was observed in the 500 s count product bottle.
Recall initiated
August 5, 2019
Reported by FDA
March 25, 2020
Distribution
PA

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Drug Recall Terminated Historical recordClass III

Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-861-08

by Strides Pharma Science Limited

Reason
Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.
Recall initiated
February 17, 2020
Reported by FDA
March 25, 2020
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-82; NDC CVS Health: 59779-540-82; NDC HEB: 37808-507-82; NDC Signature Care: 21130-116-82; NDC Walgreens: 0363-0852-82

by Perrigo Company PLC

Reason
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recall initiated
October 23, 2019
Reported by FDA
March 25, 2020
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-01; NDC CVS Health: 59779-950-01

by Perrigo Company PLC

Reason
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recall initiated
October 23, 2019
Reported by FDA
March 25, 2020
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-608-75; NDC Up & Up: 11673-023-75

by Perrigo Company PLC

Reason
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recall initiated
October 23, 2019
Reported by FDA
March 25, 2020
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Care One: 41520-392-09; NDC CVS Health: 59779-540-09; NDC Family Wellness: 55319-852-09; NDC Good Neighbor Pharmacy: 46122-532-09; NDC HEB: 37808-507-09; NDC Health Mart: 49348-109-54; NDC Meijer: 41250-891-09; NDC Rite Aid: 11822-0852-3; NDC Shopko: 37012-852-09; NDC Sound Body: 50594-852-09; NDC Sunmark: 49348-109-54; NDC Up & Up: 11673-852-09; NDC Walgreens: 0363-0852-09

by Perrigo Company PLC

Reason
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recall initiated
October 23, 2019
Reported by FDA
March 25, 2020
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 50 tablets per bottle. [Brand, NDC] NDC DG Health: 55910-852-71; NDC Good Neighbor Pharmacy: 46122-224-71; NDC Good Sense: 0113-0852-71; NDC Harris Teeter: 69256-041-71; NDC Kroger: 30142-600-71; NDC Major: 0904-6716-51; NDC Meijer: 41250-852-71; NDC Publix: 56062-099-71; NDC Rite Aid: 11822-0852-2; NDC Signature Care: 21130-116-71; NDC Topcare: 36800-852-71

by Perrigo Company PLC

Reason
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recall initiated
October 23, 2019
Reported by FDA
March 25, 2020
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. [Brand, NDC] NDC Up & Up: 11673-950-58

by Perrigo Company PLC

Reason
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recall initiated
October 23, 2019
Reported by FDA
March 25, 2020
Distribution
Nationwide 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.