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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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Drug Recall Completed Historical recordClass II

Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-257-01.

by Zydus Pharmaceuticals (USA) Inc

Reason: Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Recall initiated: October 19, 2023
Reported by FDA: November 15, 2023
Distribution: Nationwide.

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Drug Recall Completed Historical recordClass II

Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-256-01.

by Zydus Pharmaceuticals (USA) Inc

Reason: Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Recall initiated: October 19, 2023
Reported by FDA: November 15, 2023
Distribution: Nationwide.

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Drug Recall Completed Historical recordClass II

Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-255-01

by Zydus Pharmaceuticals (USA) Inc

Reason: Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Recall initiated: October 19, 2023
Reported by FDA: November 15, 2023
Distribution: Nationwide.

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Drug Recall Ongoing Historical recordClass II

Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-496-30

by Glenmark Pharmaceuticals Inc., USA

Reason: Failed Dissolution Specifications
Recall initiated: October 20, 2023
Reported by FDA: November 15, 2023
Distribution: USA nationwide

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Drug Recall Ongoing Historical recordClass III

Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11

by Zyla Life Sciences US Inc.

Reason: Sub-potent Drug: Lower potency than labeled.
Recall initiated: October 20, 2023
Reported by FDA: November 15, 2023
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08.

by VistaPharm LLC

Reason: Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Recall initiated: October 26, 2023
Reported by FDA: November 15, 2023
Distribution: Nationwide and Saudi Arabia

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Drug Recall Ongoing Historical recordClass II

Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Pradesh - 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-319-60.

by Glenmark Pharmaceuticals Inc., USA

Reason: Failed Dissolution Specifications: Out of specification for dissolution.
Recall initiated: October 23, 2023
Reported by FDA: November 15, 2023
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, NDC: 53329-169-79

by MEDLINE INDUSTRIES, LP - Northfield

Reason: CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.
Recall initiated: October 4, 2023
Reported by FDA: November 15, 2023
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10

by Amneal Pharmaceuticals of New York, LLC

Reason: Failed Dissolution Specifications
Recall initiated: October 27, 2023
Reported by FDA: November 15, 2023
Distribution: Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-3007-1

by Taro Pharmaceuticals Inc.

Reason: Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Recall initiated: November 6, 2023
Reported by FDA: November 15, 2023
Distribution: Nationwide in the USA

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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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Data last updated: November 1, 2026 ET

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.