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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 1,641–1,660 of 17,937 drug recalls

Drug Recall Ongoing Historical recordClass I

Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018, internally assigned NDC 99000-9278-64

by Revive Rx LLC dba Revive Rx Pharmacy

Reason
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Recall initiated
April 20, 2024
Reported by FDA
June 5, 2024
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-688-52

by Dr. Reddy's Laboratories, Inc.

Reason
Lack of Assurance of Sterility: Leaking vials
Recall initiated
May 23, 2024
Reported by FDA
June 5, 2024
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64

by Genentech, Inc.

Reason
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Recall initiated
May 20, 2024
Reported by FDA
June 5, 2024
Distribution
Nationwide within the United States

View recall →

Drug Recall Completed Historical recordClass I

Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25

by Hikma Injectables USA Inc

Reason
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Recall initiated
April 29, 2024
Reported by FDA
May 29, 2024
Distribution
CO, GA, PA, SD, WA

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Drug Recall Terminated Historical recordClass II

Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Regent, Inc., Shirley, NY 11967, NDC 0517-1030-01

by American Regent, Inc.

Reason
Subpotent product in addition to having out-of-specification results for impurities.
Recall initiated
May 13, 2024
Reported by FDA
May 29, 2024
Distribution
USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India.

by SOMERSET THERAPEUTICS LLC

Reason
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Recall initiated
April 24, 2024
Reported by FDA
May 29, 2024
Distribution
Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03

by Preferred Pharmaceuticals, Inc.

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Recall initiated
May 10, 2024
Reported by FDA
May 29, 2024
Distribution
Product distributed to CA, FL, OK, KS and CT

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Drug Recall Ongoing Historical recordClass III

Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Impurities/Degradation Specifications
Recall initiated
May 1, 2024
Reported by FDA
May 29, 2024
Distribution
US Nationwide.

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Drug Recall Terminated Historical recordClass II

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc., New Albany, OH 43054. NDC 72572-470-10

by American Regent, Inc.

Reason
Lack of Assurance of Sterility.
Recall initiated
May 14, 2024
Reported by FDA
May 29, 2024
Distribution
UT only

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Drug Recall Ongoing Historical recordClass III

Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC 47335-317-90

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Failed Release Testing: Out of specification for particulate matter test.
Recall initiated
April 22, 2024
Reported by FDA
May 29, 2024
Distribution
TX, PA

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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

View recall →

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

View recall →

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

View recall →

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

View recall →

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

View recall →

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

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.