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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 Ongoing Historical recordClass II

NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%) Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Gallon Jug 128 fl. oz. (3776 ml), Manufactured for Golden Tiger LLC, Made in USA, UPC 1 82294 00005 5

by ARG Laboratories, Inc.

Reason: Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Recall initiated: April 17, 2024
Reported by FDA: June 5, 2024
Distribution: Distributed Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Bottle with pump, NET WT 16 fluid oz / 473.17 ml, Made in USA, www.painwizard.com Pain Wizard LLC.PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00012 3

by ARG Laboratories, Inc.

Reason: Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Recall initiated: April 17, 2024
Reported by FDA: June 5, 2024
Distribution: Distributed Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01

by Imprimis NJOF, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: May 14, 2024
Reported by FDA: June 5, 2024
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-723-04

by Lupin Pharmaceuticals Inc.

Reason: Defective container: lack of seal integrity.
Recall initiated: May 8, 2024
Reported by FDA: June 5, 2024
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured by: Rubicon Research Private Limited, Ambernath Dist Thane 421506 India, NDC 52817-360-00

by Rubicon Research Private Limited

Reason: Presence of Foreign Substance: metal in tablet
Recall initiated: May 6, 2024
Reported by FDA: June 5, 2024
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-511-08

by Imprimis NJOF, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: May 14, 2024
Reported by FDA: June 5, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-509-08

by Imprimis NJOF, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: May 14, 2024
Reported by FDA: June 5, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01

by Imprimis NJOF, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: May 14, 2024
Reported by FDA: June 5, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-512-01

by Imprimis NJOF, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: May 14, 2024
Reported by FDA: June 5, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01

by Imprimis NJOF, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: May 14, 2024
Reported by FDA: June 5, 2024
Distribution: Nationwide within the United States

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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

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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

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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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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.