Clonazepam Tablets Recalled Due to Incorrect Carton Labeling
Endo USA recalls clonazepam tablets because some cartons are labeled with incorrect declared strength. The medication inside the blister strips contains the correct strength.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I designation establishes a minimum severity score of 4 per the classification rules. Although no illnesses or injuries have been reported, the labeling discrepancy on a controlled benzodiazepine carton justifies this severity level.
Plain-English summary
Endo USA, Inc. is recalling Clonazepam Orally Disintegrating Tablets USP 0.25 mg because some product cartons are labeled with incorrect declared strength. However, the blister strips inside the product carton reflect the correct strength.
The recall affects 72,973 cartons distributed nationwide. The affected cartons are from lots 550142801, 550142901, 550143001, 550143101, 550143201, 550143301, 550143401, 550147201, and 550147401, with an expiration date of August 31, 2026. The product is distributed by PAR Pharmaceutical, Chestnut Ridge, New York.
The recalled product
- Product
- CLONAZEPAM (CLONAZEPAM)
- Brand
- CLONAZEPAM
- Manufacturer
- Endo USA, Inc.
- Hazard
- Affected units
- 72,973
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Lot #s: 550142801
- 550142901
- 550143001
- 550143101
- 550143201
- 550143301
- 550143401
- 550147201
- 550147401
- Exp. 08/31/2026.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Endo USA, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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