Why it was recalled
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Product description
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 numbers, UPCs & expiration codes
Lot #s: 550142801, 550142901, 550143001, 550143101, 550143201, 550143301, 550143401, 550147201, 550147401, Exp. 08/31/2026.
Where it was sold
Nationwide in the USA
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-0180-2025
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Nov 18, 2024
- FDA report date
- Jan 15, 2025
- Quantity
- 72,973 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Endo USA, Inc.
Original FDA data
Every field from FDA enforcement report D-0180-2025, exactly as published.
Show all FDA fields
- City
- Malvern
- State
- PA
- Status
- Ongoing
- Country
- United States
- Event ID
- 95778
- Address
- 1400 Atwater Dr
- Code information
- Lot #s: 550142801, 550142901, 550143001, 550143101, 550143201, 550143301, 550143401, 550147201, 550147401, Exp. 08/31/2026.
- Postal code
- 19355-8701
- Report date
- Jan 15, 2025
- Product type
- Drugs
- Recall number
- D-0180-2025
- Classification
- Class I
- Recalling firm
- Endo USA, Inc.
- Product quantity
- 72,973 cartons
- Reason for recall
- Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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).
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Nov 18, 2024
- Initial firm notification
- Press Release
- Center classification date
- Jan 3, 2025