Endo Pharmaceuticals, Inc. recalls Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6
Endo Pharmaceuticals recalls Clonazepam orally disintegrating tablets with incorrect strength labeling. Some cartons listed 0.125mg instead of 0.25mg, but tablets inside are correct. Consumers should check their product.
Lower-risk recall
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.
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What happened, in plain English
Endo Pharmaceuticals is recalling Clonazepam orally disintegrating tablets that were incorrectly labeled as 0.125mg instead of 0.25mg. This labeling error could lead to incorrect dosing if the product is used without checking the actual strength. Read more at govinfonow.com/recall/32590-endo-clonazepam-tablets-recalled-due-to-labeling-error.
Source Summary by GovInfoNow · govinfonow.com/recall/32590-endo-clonazepam-tablets-recalled-due-to-labeling-error · Updated September 23, 2026 · FDA enforcement record: FDA #D-0622-2024
Cite this page
“Endo Clonazepam Tablets Recalled Due to Labeling Error.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32590-endo-clonazepam-tablets-recalled-due-to-labeling-error. Based on FDA recall #D-0622-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0622-2024%22&limit=1).
Why it’s dangerous
The product was labeled as 0.125mg but contains 0.25mg tablets. This labeling error could cause a patient to take twice the intended dose if they rely on the label for dosing instructions.
Who’s affected
People who have the recalled Clonazepam tablets (0.125mg labeled but 0.25mg actual) are at risk of incorrect dosing. Prescribers and patients using these tablets should check the product.
How to tell if you have this one
Check for the product name 'Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg' on the carton. The actual tablets inside are 0.25mg, but the carton may incorrectly state 0.125mg.
- Brand
Endo Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Label
Look for the carton label stating 0.125mg instead of 0.25mg. The tablets inside are correctly labeled as 0.25mg.
Questions people ask
Why is this product being recalled?
The product was incorrectly labeled as 0.125mg instead of 0.25mg on the carton, but the tablets inside are the correct strength.
Is this product dangerous?
This labeling error could lead to incorrect dosing if the product is used without checking the actual strength, but it does not pose an immediate safety risk.
How can I tell if I have the recalled product?
Check the carton label for 'Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg' with the correct tablets inside being 0.25mg.
Contact Endo Pharmaceuticals
We’ve drafted a message you can send Endo Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0622-2024 — Endo Pharmaceuticals Endo Pharmaceuticals Hello, I own a Endo Pharmaceuticals that is covered by recall D-0622-2024 from Endo Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0622-2024 (July 10, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0622-2024 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.
