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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 1,761–1,780 of 18,047 drug recalls

Drug Recall Ongoing Historical recordClass II

Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free Grape, 10 fl. oz bottle, Distributed by: Meijer Distribution Inc., Grand Rapids,MI 49544, NDC 79481-0034-9

by Pharma Nobis LLC

Reason
Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Recall initiated
May 1, 2024
Reported by FDA
May 22, 2024
Distribution
USA Nationwide

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Drug Recall Ongoing Historical recordClass II

CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Flavor, 10 fl. oz bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10.

by Pharma Nobis LLC

Reason
Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Recall initiated
May 1, 2024
Reported by FDA
May 22, 2024
Distribution
USA Nationwide

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Drug Recall Ongoing Historical recordClass II

MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10

by Sagent Pharmaceuticals

Reason
Presence of Particulate Matter: Potential for black particulates in the drug product.
Recall initiated
April 25, 2024
Reported by FDA
May 22, 2024
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-050-44

by MACLEODS PHARMA USA, INC

Reason
Presence of foreign substance: plastic-like substance.
Recall initiated
May 7, 2024
Reported by FDA
May 22, 2024
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass II

Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04

by Lupin Pharmaceuticals Inc.

Reason
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Recall initiated
April 24, 2024
Reported by FDA
May 22, 2024
Distribution
USA nationwide

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Drug Recall Terminated Historical recordClass II

Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-723-04

by Lupin Pharmaceuticals Inc.

Reason
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Recall initiated
April 24, 2024
Reported by FDA
May 22, 2024
Distribution
USA nationwide

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Drug Recall Completed Historical recordClass II

Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01

by Dercher Enterprises, Inc., DBA Gordon Laboratories

Reason
cGMP Deviations
Recall initiated
April 12, 2024
Reported by FDA
May 22, 2024
Distribution
Product was distributed nationwide within the United States

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Drug Recall Terminated Historical recordClass I

Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by VSD Productions Inc., Las Vegas, NV.

by Stop Clopez Corp

Reason
Marketed Without An Approved NDA/ANDA
Recall initiated
April 22, 2024
Reported by FDA
May 22, 2024
Distribution
Distribution worldwide via amazon.com

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Drug Recall Ongoing Historical recordClass II

Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti Halol-389350, Gujarat, India. NDC 62756-233-01

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Out of specification for assay
Recall initiated
April 19, 2024
Reported by FDA
May 15, 2024
Distribution
Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.

by Aurobindo Pharma USA Inc.

Reason
Discoloration: Dotted and yellow spots on tablets
Recall initiated
April 24, 2024
Reported by FDA
May 15, 2024
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.

by Aurobindo Pharma USA Inc.

Reason
Discoloration: Dotted and yellow spots on tablets
Recall initiated
April 24, 2024
Reported by FDA
May 15, 2024
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06

by Acella Pharmaceuticals, LLC

Reason
Subpotent drug
Recall initiated
April 24, 2024
Reported by FDA
May 15, 2024
Distribution
Nationwide in the US and Puerto Rico.

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Drug Recall Terminated Historical recordClass II

TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, 724.465.8762

by RemedyRePack Inc.

Reason
Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
Recall initiated
May 2, 2024
Reported by FDA
May 15, 2024
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ

by FDC Limited

Reason
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Recall initiated
April 25, 2024
Reported by FDA
May 15, 2024
Distribution
New Jersey Only

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Drug Recall Ongoing Historical recordClass II

traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited, Ambernath, Dist. Thane, 421506 India NDC 72888-080-00

by Rubicon Research Private Limited

Reason
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Recall initiated
April 26, 2024
Reported by FDA
May 15, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass I

Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.

by Dr. Reddy's Laboratories, Inc.

Reason
Sub-potent Drug; powder discoloration associated with decreased potency
Recall initiated
April 8, 2024
Reported by FDA
May 15, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass I

Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30.

by Dr. Reddy's Laboratories, Inc.

Reason
Sub-potent Drug; powder discoloration associated with decreased potency
Recall initiated
April 8, 2024
Reported by FDA
May 15, 2024
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC: 51991-748-90.

by Breckenridge Pharmaceutical, Inc

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Recall initiated
April 29, 2024
Reported by FDA
May 15, 2024
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC 51991-746-05.

by Breckenridge Pharmaceutical, Inc

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Recall initiated
April 29, 2024
Reported by FDA
May 15, 2024
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.

by Breckenridge Pharmaceutical, Inc

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Recall initiated
April 29, 2024
Reported by FDA
May 15, 2024
Distribution
US 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.

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