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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 Terminated Historical recordClass I

Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1282-94

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Recall initiated: October 31, 2023
Reported by FDA: November 29, 2023
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass I

Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Recall initiated: October 31, 2023
Reported by FDA: November 29, 2023
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Family Medical Supply, 2011 W Cumberland St. Dunn, NC 28334.

by Family Medical Supply Inc

Reason: cGMP Deviations
Recall initiated: November 9, 2023
Reported by FDA: November 22, 2023
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 05961 9

by Omega & Delta Co., Inc.

Reason: Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Recall initiated: October 20, 2023
Reported by FDA: November 22, 2023
Distribution: Distributed in Puerto Rico only.

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Drug Recall Ongoing Historical recordClass II

DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237mL) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00030 4

by Omega & Delta Co., Inc.

Reason: Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Recall initiated: October 20, 2023
Reported by FDA: November 22, 2023
Distribution: Distributed in Puerto Rico only.

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Drug Recall Ongoing Historical recordClass II

DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Original, 4FL OZ (118 ml) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00027 4

by Omega & Delta Co., Inc.

Reason: Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Recall initiated: October 20, 2023
Reported by FDA: November 22, 2023
Distribution: Distributed in Puerto Rico only.

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Drug Recall Terminated Historical recordClass I

2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4903-11

by Pfizer Inc.

Reason: Presence of Particulate Matter: identified as glass.
Recall initiated: October 2, 2023
Reported by FDA: November 15, 2023
Distribution: Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.

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Drug Recall Terminated Historical recordClass I

1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4904-11

by Pfizer Inc.

Reason: Presence of Particulate Matter: identified as glass.
Recall initiated: October 2, 2023
Reported by FDA: November 15, 2023
Distribution: Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.

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Drug Recall Terminated Historical recordClass I

4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5534-24

by Pfizer Inc.

Reason: Presence of Particulate Matter: identified as glass.
Recall initiated: October 2, 2023
Reported by FDA: November 15, 2023
Distribution: Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.

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Drug Recall Terminated Historical recordClass III

V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActive Nutritional, Inc., 1803 N. Wickham Rd., Melbourne, FL 32935

by Grato Holdings, Inc.

Reason: Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).
Recall initiated: October 30, 2023
Reported by FDA: November 15, 2023
Distribution: Distributed to one direct account in Florida with possible further distribution out of state.

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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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Data last updated: September 9, 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.