Why it was recalled
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.
Product description
Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02.
Lot numbers, UPCs & expiration codes
Lot 550147301, Exp. 08/31/2026
Where it was sold
Nationwide in the USA and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0622-2024
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 10, 2024
- FDA report date
- Aug 7, 2024
- Quantity
- 8,139 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Endo Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0622-2024, exactly as published.
Show all FDA fields
- City
- Malvern
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 94945
- Address
- 1400 Atwater Dr
- Code information
- Lot 550147301, Exp. 08/31/2026
- Postal code
- 19355-8701
- Report date
- Aug 7, 2024
- Product type
- Drugs
- Recall number
- D-0622-2024
- Classification
- Class I
- Recalling firm
- Endo Pharmaceuticals, Inc.
- Product quantity
- 8,139 cartons
- Termination date
- Sep 16, 2025
- Reason for 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Jul 10, 2024
- Initial firm notification
- Letter
- Center classification date
- Jul 30, 2024