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Stop using now Drug recall · FDA · Published December 13, 2024

Recall: Amneal Clobazam 10mg Tablets with Foreign Tablets Risk

Amneal Pharmaceuticals recalls 10mg Clobazam tablets due to foreign tablets in packaging. Affected lots: 1019594, expiring 12/31/2025. Stop using and contact for replacement.

🇺🇸 FDA recall #D-0184-2025DrugAmneal Pharmaceuticals ›
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Recalling firmAmerisource Health Services LLC2550 John Glenn Ave Ste A · Columbus, OH 43217-1188
✎ GovInfoNow plain-language explainer

What happened, in plain English

Amneal Pharmaceuticals is recalling 10mg Clobazam tablets that may contain foreign tablets. This could lead to unintended ingestion of harmful substances if the tablets are taken without proper identification. Read more at govinfonow.com/recall/32362-recall-amneal-clobazam-10mg-tablets-with-foreign-tablets-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/32362-recall-amneal-clobazam-10mg-tablets-with-foreign-tablets-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0184-2025

Cite this page

“Recall: Amneal Clobazam 10mg Tablets with Foreign Tablets Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32362-recall-amneal-clobazam-10mg-tablets-with-foreign-tablets-risk. Based on FDA recall #D-0184-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0184-2025%22&limit=1).

Why it’s dangerous

The packaging contains foreign tablets that could be mistaken for the intended medication. If taken, this could cause unintended ingestion of harmful substances.

Who’s affected

Prescription patients who have received the recalled lot (1019594) of Clobazam tablets. Those with a prescription for this medication are most at risk.

How to tell if you have this one

Check for the lot number 1019594 on the packaging. The product is a prescription-only 10mg Clobazam tablet in 30-count cartons with 3x10 blister cards.

  • Brand
    Amneal Pharmaceuticals
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Now

    Immediately stop using the recalled Clobazam tablets as they may contain foreign tablets that could be harmful.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 33 days after the firm started it.

1. Firm started the recall: Dec 13, 202412. FDA classified it Class II: Jan 6, 202523. Published in FDA’s Enforcement Report: Jan 15, 2025320242025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0184-2025 (December 13, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0184-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA