The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0179-2025·Announced 2025-01-15

Clonazepam Orally Disintegrating Tablets Carton Mislabeled on Declared Strength

Endo USA recalls 8,029 cartons of Clonazepam 0.125 mg tablets nationwide due to incorrect carton labeling, although the tablets in the blister strips have 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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA has classified this recall as Class I, which indicates a reasonable probability of serious adverse health consequences. The labeling error involves a benzodiazepine medication where dosing accuracy is critical.

Plain-English summary

Endo USA, Inc. is recalling 8,029 cartons of Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, distributed nationwide. The product is supplied as a benzodiazepine medication in packages of 60 tablets (10 blister cards containing 6 tablets each). The affected lot is Lot #550174101 with an expiration date of January 31, 2027.

The recall was initiated due to a labeling error on the carton. Some cartons were labeled with an incorrect declared strength. However, the blister strips contained inside each carton show the correct strength.

This recall affects consumers, healthcare providers, and pharmacies who may have received the affected cartons nationwide. The FDA classified this as a Class I recall due to the potential for dosing confusion regarding medication strength on a controlled benzodiazepine medication.

Consumers and healthcare providers who have this product should verify the strength on the individual blister strips rather than relying on the carton label. Contact a healthcare provider or pharmacist with any questions regarding the affected medication.

The recalled product

Product
CLONAZEPAM (CLONAZEPAM)
Brand
CLONAZEPAM
Manufacturer
Endo USA, Inc.
Category
Drug
Hazard
Affected units
8,029

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 (2)

  • Lot #: 550174101
  • Exp. 01/31/2027.

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 →

Related recalls

Same brand · CLONAZEPAM

Same manufacturer · Endo USA, Inc.

See all →

Same hazard · mis labeling

See all →

Similar recalls