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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 6,341–6,360 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Care One: 41520-609-62; NDC CVS Health: 59779-950-62; NDC DG Health: 55910-423-62; NDC Equaline: 41163-950-62; NDC Family Wellness: 55319-523-62; NDC Good Neighbor Pharmacy: 46122-041-62; NDC HEB: 37808-710-02; NDC Kroger: 30142-891-02; NDC Leader: 70000-0378-1; NDC Meijer: 41250-950-02; NDC Rite Aid: 11822-0950-0; NDC Shopko: 37012-950-62; NDC Signature Care: 21130-568-62; NDC Topcare: 36800-950-62; NDC Walgreens: 0363-0950-02

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, 24 tablets per bottle. [Brand, NDC] NDC Being Well: 46994-852-62; NDC Care One 41520-392-02; NDC CVS Health: 59779-540-02; NDC DG Health: 55910-852-02; NDC Equaline: 41163-852-62; NDC Equate: 49035-608-02; NDC Exchange Select: 55301-852-02; NDC Family Wellness: 55319-852-02; NDC Good Neighbor Pharmacy: 46122-224-62; NDC Good Sense 0113-0852-62; NDC Harris Teeter: 69256-041-62; NDC Health Mart 49348-109-04; NDC Kroger 30142-600-02; NDC Major 0904-6716-24; NDC Meijer: 41250-852-02; NDC Publix: 56062-099-02; NDC Rite Aid 11822-0852-5; NDC Select 7: 10202-852-62; NDC Shop Rite 41190-852-62; NDC Shopko: 37012-852-62; NDC Signature Care: 21130-116-02; NDC Sound Body: 50594-852-02; NDC Sunmark: 62011-0282-1; NDC Topcare: 36800-852-02; NDC Up & Up: 11673-023-02; NDC Walgreens: 0363-0852-62

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, 160 tablets per bottle. [NDC: Brand] NDC CVS Health.: 69842-293-06

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, 80 tablets per bottle. [NDC: Brand] NDC Basic Care: 0113-7876-27; NDC CVS Health: 69842-293-27; NDC Leader: 70000-0375-2; NDC Up & Up: 11673-876-27; NDC Walgreens: 0363-1876-27

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, 30 tablets per bottle. [NDC: Brand] NDC CVS Health: 69842-293-65; NDC Equaline 41163-931-65; NDC Family Wellness: 55319-876-65; NDC Good Sense 0113-0876-65; NDC H.E.B.: 37808-876-65; NDC Harris Teeter: 69256-876-65; NDC Health Mart: 62011-0283-1; NDC Leader: 62011-0283-1; NDC Major: 0904-6715-46; NDC Signature Care: 21130-118-65; NDC Sunmark: 49348-136-44; NDC Up & Up: 11673-876-65; NDC Walgreens: 0363-1876-65

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

Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wallet of 28 Tablets (NDC 68180-857-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-857-13); Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.

by Lupin Pharmaceuticals Inc.

Reason
Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
Recall initiated
March 9, 2020
Reported by FDA
March 18, 2020
Distribution
Nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass III

Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in 1 Wallet of 28 Tablets (NDC 68180-879-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-879-13), Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.

by Lupin Pharmaceuticals Inc.

Reason
Failed Content Uniformity Specifications: Out Of Specification test results observed for content and blend uniformity.
Recall initiated
March 9, 2020
Reported by FDA
March 18, 2020
Distribution
Nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Morphine Sulfate (MITIGO), 5 mg/mL intrathecal, 40 mL per syringe. Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901

by Redline Pharmacy Solutions

Reason
Lack Of Processing Controls
Recall initiated
February 24, 2020
Reported by FDA
March 18, 2020
Distribution
Sold to patients in Nebraska

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Drug Recall Terminated Historical recordClass II

Vancomycin 900MG in 100ML 0.9% NACL Injectable, Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901

by Redline Pharmacy Solutions

Reason
Lack Of Processing Controls
Recall initiated
February 24, 2020
Reported by FDA
March 18, 2020
Distribution
Sold to patients in Nebraska

View recall →

Drug Recall Terminated Historical recordClass II

Ertapenem in 100ML 0.9% NACL 1GM Injectable, Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901

by Redline Pharmacy Solutions

Reason
Lack Of Processing Controls
Recall initiated
February 24, 2020
Reported by FDA
March 18, 2020
Distribution
Sold to patients in Nebraska

View recall →

Drug Recall Terminated Historical recordClass II

Daptomycin, 500MG in 0.9% NACL 100ML Injectable Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901

by Redline Pharmacy Solutions

Reason
Lack Of Processing Controls
Recall initiated
February 24, 2020
Reported by FDA
March 18, 2020
Distribution
Sold to patients in Nebraska

View recall →

Drug Recall Terminated Historical recordClass II

Morphine Sulfate, 20 mg/mL intrathecal, 20 mL per syringe. Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901

by Redline Pharmacy Solutions

Reason
Lack Of Processing Controls
Recall initiated
February 24, 2020
Reported by FDA
March 18, 2020
Distribution
Sold to patients in Nebraska

View recall →

Drug Recall Terminated Historical recordClass II

Acetylcysteine Ophthalmic 10% Solution, 5 mL per dropper bottle (10ML). Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901

by Redline Pharmacy Solutions

Reason
Lack Of Processing Controls
Recall initiated
February 24, 2020
Reported by FDA
March 18, 2020
Distribution
Sold to patients in Nebraska

View recall →

Drug Recall Terminated Historical recordClass II

Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30), b) 42-count bottles (NDC 52959-0002-42), c) 45-count bottles (NDC 52959-0002-45) and e) 50-count bottles (NDC 52959-0002-50) Repack: H.J. Harkins Co., Inc. Grover Beach, CA 93433

by H J Harkins Company Inc dba Pharma Pac

Reason
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle
Recall initiated
March 6, 2020
Reported by FDA
March 18, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080

by Precision Dose Inc.

Reason
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Recall initiated
November 13, 2019
Reported by FDA
March 18, 2020
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11

by American Health Packaging

Reason
CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Recall initiated
November 20, 2019
Reported by FDA
March 18, 2020
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass III

Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6804-61

by The Harvard Drug Group

Reason
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Recall initiated
February 27, 2020
Reported by FDA
March 18, 2020
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6803-61

by The Harvard Drug Group

Reason
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Recall initiated
February 27, 2020
Reported by FDA
March 18, 2020
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6802-61

by The Harvard Drug Group

Reason
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Recall initiated
February 27, 2020
Reported by FDA
March 18, 2020
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6801-61

by The Harvard Drug Group

Reason
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Recall initiated
February 27, 2020
Reported by FDA
March 18, 2020
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.