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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 2,061–2,080 of 17,937 drug recalls

Drug Recall Ongoing Historical recordClass III

Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC 0074-7068-11

by AbbVie Inc.

Reason
Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
Recall initiated
October 17, 2023
Reported by FDA
November 15, 2023
Distribution
Distributed in the US. No government or foreign consignees.

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Drug Recall Terminated Historical recordClass II

Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-05

by Par Sterile Products LLC

Reason
Crystallization; identified as Buprenorphine free base
Recall initiated
November 9, 2021
Reported by FDA
November 15, 2023
Distribution
Nationwide USA

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Drug Recall Terminated Historical recordClass II

Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10.

by Dr. Reddy's Laboratories, Inc.

Reason
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
Recall initiated
October 13, 2023
Reported by FDA
November 15, 2023
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-879-01

by Glenmark Pharmaceuticals Inc., USA

Reason
Failed Impurities/Degradation Specifications
Recall initiated
October 20, 2023
Reported by FDA
November 8, 2023
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191,(U.T. of D & NH), India. NDC 62756-590-88

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Failed Impurities/Degradation Specifications.
Recall initiated
October 20, 2023
Reported by FDA
November 8, 2023
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191,(U.T. of D & NH), India. NDC 62756-589-88

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Failed Impurities/Degradation Specifications.
Recall initiated
October 20, 2023
Reported by FDA
November 8, 2023
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor Health, LLC, Woburn, MA 01801. NDC# 48433-230-15

by Safecor Health, LLC

Reason
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Recall initiated
October 19, 2023
Reported by FDA
November 8, 2023
Distribution
Distributed Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per carton, Rx Only, Manufactured By Padagis, Yeruham, Israel; Distributed By: Padagis, Allegan, MI 49010. NDC: 45802-396-01

by Padagis US LLC

Reason
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Recall initiated
September 28, 2023
Reported by FDA
November 8, 2023
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass III

Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054, NDC 42799-217-01

by Edenbridge Pharmaceuticals, LLC

Reason
Subpotent Drug
Recall initiated
October 20, 2023
Reported by FDA
November 8, 2023
Distribution
Nationwide within the United States

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Drug Recall Completed Historical recordClass II

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-83, UPC 3-0766-0746-50-8

by GlaxoSmithKline Consumer Healthcare Holdings LLC

Reason
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Recall initiated
December 2, 2022
Reported by FDA
November 8, 2023
Distribution
Nationwide within the United States

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Drug Recall Completed Historical recordClass II

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 265-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-05, UPC 3-0766-3072-14-7

by GlaxoSmithKline Consumer Healthcare Holdings LLC

Reason
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Recall initiated
December 2, 2022
Reported by FDA
November 8, 2023
Distribution
Nationwide within the United States

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Drug Recall Completed Historical recordClass II

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-03, UPC 3-0766-0746-70-6

by GlaxoSmithKline Consumer Healthcare Holdings LLC

Reason
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Recall initiated
December 2, 2022
Reported by FDA
November 8, 2023
Distribution
Nationwide within the United States

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Drug Recall Completed Historical recordClass II

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 72-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-02, UPC 3-0766-0746-50-8

by GlaxoSmithKline Consumer Healthcare Holdings LLC

Reason
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Recall initiated
December 2, 2022
Reported by FDA
November 8, 2023
Distribution
Nationwide within the United States

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Drug Recall Completed Historical recordClass II

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets, packaged in 160-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-14, UPC 3-0766-0746-10-2

by GlaxoSmithKline Consumer Healthcare Holdings LLC

Reason
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Recall initiated
December 2, 2022
Reported by FDA
November 8, 2023
Distribution
Nationwide within the United States

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Drug Recall Completed Historical recordClass II

TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-01, UPC 3-0766-0746-80-5

by GlaxoSmithKline Consumer Healthcare Holdings LLC

Reason
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Recall initiated
December 2, 2022
Reported by FDA
November 8, 2023
Distribution
Nationwide within the United States

View recall →

Drug Recall Completed Historical recordClass II

TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-06, UPC 3-0766-0745-85-3

by GlaxoSmithKline Consumer Healthcare Holdings LLC

Reason
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Recall initiated
December 2, 2022
Reported by FDA
November 8, 2023
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass III

VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-029-68.

by Denver Solutions, LLC DBA Leiters Health

Reason
Labeling: Not Elsewhere Classified
Recall initiated
October 4, 2023
Reported by FDA
November 1, 2023
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass III

VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-028-68.

by Denver Solutions, LLC DBA Leiters Health

Reason
Labeling: Not Elsewhere Classified
Recall initiated
October 4, 2023
Reported by FDA
November 1, 2023
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass III

Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-157-70

by Denver Solutions, LLC DBA Leiters Health

Reason
Labeling: Not Elsewhere Classified
Recall initiated
October 4, 2023
Reported by FDA
November 1, 2023
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass II

Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA

by Biomic Sciences, LLC dba ION Intelligence of Nature

Reason
Microbial contamination of Non-Sterile Products
Recall initiated
September 29, 2023
Reported by FDA
November 1, 2023
Distribution
Nationwide in the United States and to Canada, New Zealand, Australia, Indonesia, Malaysia, Great Britain, and the Netherlands

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.