The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0180-2025·Announced 2025-01-15

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.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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.
Category
Drug — Benzodiazepine / Labeling Error
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 →

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