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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 1,621–1,640 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Glass Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-005-01, NDC (sample lot) 61755-005-54

by Regeneron Pharmaceuticals Inc

Reason
Lack of Assurance of Sterility: Complaints of syringe breakage
Recall initiated
May 15, 2024
Reported by FDA
June 5, 2024
Distribution
USA nationwide.

View recall →

Drug Recall Ongoing Historical recordClass II

ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 4 OZ (113g), Manufactured for AGS Brands. UPC 0 17971 10421 7

by ARG Laboratories, Inc.

Reason
Out of Specification for active ingredient
Recall initiated
April 17, 2024
Reported by FDA
June 5, 2024
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Roll-On NET WT 3 fl. oz. (88.7ml), Manufactured for Golden Tiger USA Albuquerque, NM, UPC 1 82294 00006 2

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

View recall →

Drug Recall Ongoing Historical recordClass II

Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Roll-On 3 fl oz (88.7ml), painwizard.com Made in the USA, PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00010 9

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

View recall →

Drug Recall Ongoing Historical recordClass II

NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Tube 4 oz (113.39 g), Mfr. for Golden Tiger USA Albuq, NM, UPC 1 82294 00002 4

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

View recall →

Drug Recall Ongoing Historical recordClass II

NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Pump Capsaicin, Aloe Vera, Willow Bark & MSM, Bottle with Pump NET WT 32 fl. oz (946.33ml), Manufactured for Golden Tiger LLC Made in USA, UPC 1 82294 00004 8

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

View recall →

Drug Recall Ongoing Historical recordClass II

Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 4oz (113.39g), painwizard.com Made in the USA, PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00019 2

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

View recall →

Drug Recall Ongoing Historical recordClass II

Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 8 oz (226.79g), Made in the USA, painwizard.com PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00011 6

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

View recall →

Drug Recall Ongoing Historical recordClass II

ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), Original Formula, SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 1 OZ (28 g), Manufactured for AGS Brands.

by ARG Laboratories, Inc.

Reason
Out of Specification for active ingredient
Recall initiated
April 17, 2024
Reported by FDA
June 5, 2024
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad Spectrum Sunscreen with UVA/UVB Protection, NEW WT. 5 FL OZ (148ML), Distributed by: Bullfrog Brands LLC, PO Box 600207, Dallas, TX 75360 USA. UPC 8 50016 52112 5

by ARG Laboratories, Inc.

Reason
Out of Specification for active ingredient
Recall initiated
April 17, 2024
Reported by FDA
June 5, 2024
Distribution
Distributed Nationwide in the USA

View recall →

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

View recall →

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

View recall →

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

View recall →

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

View recall →

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

View recall →

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

View recall →

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

View recall →

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

View recall →

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

View recall →

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

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.