Endo USA, Inc. recalls Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards
Endo USA recalls 0.125 mg Clonazepam orally disintegrating tablets with incorrect labeling. Some cartons show wrong strength but blister strips indicate correct dosage. No action needed as the error is not dangerous.
Lower-risk recall
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Contact the company & request your remedy
What happened, in plain English
Endo USA recalled 0.125 mg Clonazepam orally disintegrating tablets due to a labeling error. The error means some cartons show the wrong strength, but the actual tablets inside are correct. This does not pose a safety risk to users. Read more at govinfonow.com/recall/32411-endo-recalls-clonazepam-tablets-due-to-labeling-error.
Source Summary by GovInfoNow · govinfonow.com/recall/32411-endo-recalls-clonazepam-tablets-due-to-labeling-error · Updated August 17, 2026 · FDA enforcement record: FDA #D-0179-2025
Cite this page
“Endo recalls Clonazepam tablets due to labeling error.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32411-endo-recalls-clonazepam-tablets-due-to-labeling-error. Based on FDA recall #D-0179-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0179-2025%22&limit=1).
Why it’s dangerous
The labeling error means some cartons incorrectly state the strength of the tablets. However, the blister strips inside the carton show the correct strength. This error does not affect the safety of the medication itself.
Who’s affected
Prescription users of Clonazepam tablets who received the recalled product. Those most at risk are individuals taking the medication as directed without confusion about dosage.
How to tell if you have this one
Check for cartons labeled with NDC 49884-306-02 (60 tablets) or NDC 49884-306-52 (blisters). The product was distributed by PAR Pharmaceutical with lot number 550174101, expiring 01/31/2027.
- Brand
Endo- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Ongoing- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0178-2025 | Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 tablets each, Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-310-02 (carton), NDC#: 49884-310-52 (blisters).; Lot # 550176501, 550176601, Exp 02/28/2027. | 9,816 cartons | 49884-306-02, 49884-307-02, 49884-308-02, 49884-309-02, 49884-310-02, 49884-310-52 |
| D-0179-2025 | Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-306-02 (carton), NDC #: 49884-306-52 (blisters).; Lot #: 550174101, Exp. 01/31/2027. | 8,029 cartons | 49884-306-02, 49884-307-02, 49884-308-02, 49884-309-02, 49884-310-02, 49884-306-52 |
| D-0180-2025 | Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-307-02 (carton), NDC #: 49884-307-52 (blisters).; Lot #s: 550142801, 550142901, 550143001, 550143101, 550143201, 550143301, 550143401, 550147201, 550147401, Exp. 08/31/2026. | 72,973 cartons | 49884-306-02, 49884-307-02, 49884-308-02, 49884-309-02, 49884-310-02, 49884-307-52 |
| D-0181-2025 | Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-309-02 (carton), NDC #: 49884-309-52 (blisters).; Lot #s: 550145201, Exp. 08/31/2026; 550175901, 550176001, 550176201, Exp. 02/28/2027 | 22,513 cartons | 49884-306-02, 49884-307-02, 49884-308-02, 49884-309-02, 49884-310-02, 49884-309-52 |
What to do — step by step
Check Labeling
Verify the blister strips inside the carton show the correct strength (0.125 mg) as the carton may have an incorrect label.
Questions people ask
Is this product dangerous?
No, the labeling error does not affect the safety of the medication. The actual tablets inside are correct.
Do I need to stop using these tablets?
No action is needed. The error is only in the carton labeling, not the tablets themselves.
How can I tell if I have the recalled product?
Look for cartons with NDC 49884-306-02 (60 tablets) or NDC 49884-306-52 (blisters), distributed by PAR Pharmaceutical with lot number 550174101.
Contact Endo
We’ve drafted a message you can send Endo to request your refund or repair — edit it as you like.
Subject: Recall D-0179-2025 — Endo Endo Hello, I own a Endo that is covered by recall D-0179-2025 from Endo. 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-0179-2025 (November 18, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0179-2025 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.