The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0178-2025·Announced 2025-01-15

Clonazepam tablets recalled for incorrect carton labeling

Endo USA is recalling approximately 9,816 cartons of Clonazepam 2 mg tablets due to incorrect strength labeling on the carton exterior. The blister strips inside contain the correct formulation.

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 classification mandates minimum severity of Severe. Although the actual product inside contains the correct formulation, incorrect labeling on a controlled substance creates potential for medication errors.

Plain-English summary

Clonazepam 2 mg orally disintegrating tablets (60 tablets per carton) manufactured by Endo USA and distributed by PAR Pharmaceutical have been recalled due to labeling errors. Approximately 9,816 cartons with lot numbers 550176501 and 550176601 (expiring 02/28/2027) were distributed nationwide.

Some cartons contain incorrect labeling on the declared strength. However, the blister strips (the actual tablets) inside each affected carton contain the correct strength formulation.

Patients nationwide who received medications from the affected lots should check their carton labeling against their prescription to ensure accuracy. If the carton labeling does not match the prescribed strength, patients should contact their pharmacy or healthcare provider before taking the medication.

The recalled product

Product
CLONAZEPAM (CLONAZEPAM)
Brand
CLONAZEPAM
Manufacturer
Endo USA, Inc.
Category
Drug — Prescription Benzodiazepine
Hazard
Affected units
9,816

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 (3)

  • Lot # 550176501
  • 550176601
  • Exp 02/28/2027.

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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