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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 III

Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Limited, Anakapalli-531011, India, NDC 64980-411-10

by Rising Pharma Holding, Inc.

Reason: Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
Recall initiated: May 16, 2024
Reported by FDA: June 12, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass III

Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9207-1.

by Bryant Ranch Prepack, Inc.

Reason: Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Recall initiated: May 10, 2024
Reported by FDA: June 12, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass III

Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9206-1.

by Bryant Ranch Prepack, Inc.

Reason: Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'
Recall initiated: May 10, 2024
Reported by FDA: June 12, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass III

Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-8858-1.

by Bryant Ranch Prepack, Inc.

Reason: Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Recall initiated: May 10, 2024
Reported by FDA: June 12, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass III

Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: cephalexin monohydrate, USP equivalent to 2.5g of cephalexin in a strawberry flavored mixture. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9205-1.

by Bryant Ranch Prepack, Inc.

Reason: Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g
Recall initiated: May 10, 2024
Reported by FDA: June 12, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass III

Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9204-1.

by Bryant Ranch Prepack, Inc.

Reason: Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'
Recall initiated: May 10, 2024
Reported by FDA: June 12, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-468-06

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Recall initiated: May 13, 2024
Reported by FDA: June 12, 2024
Distribution: US Nationwide.

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Drug Recall Ongoing Historical recordClass II

Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-467-06

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Recall initiated: May 13, 2024
Reported by FDA: June 12, 2024
Distribution: US Nationwide.

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Drug Recall Ongoing Historical recordClass II

Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-466-99

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Recall initiated: May 10, 2024
Reported by FDA: June 12, 2024
Distribution: US Nationwide.

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Drug Recall Ongoing Historical recordClass II

Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-465-99

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Recall initiated: May 10, 2024
Reported by FDA: June 12, 2024
Distribution: US Nationwide.

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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.

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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

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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, 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

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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, 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

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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, 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

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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

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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, 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

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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, 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

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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

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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

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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.