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.
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
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.
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.
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.
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.
Verify the blister strips inside the carton show the correct strength (0.125 mg) as the carton may have an incorrect label.
No, the labeling error does not affect the safety of the medication. The actual tablets inside are correct.
No action is needed. The error is only in the carton labeling, not the tablets themselves.
Look for cartons with NDC 49884-306-02 (60 tablets) or NDC 49884-306-52 (blisters), distributed by PAR Pharmaceutical with lot number 550174101.
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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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.
