Clonazepam Tablets Recalled Due to Carton Labeling Error
Endo Pharmaceuticals is recalling 8,139 cartons of Clonazepam Orally Disintegrating Tablets due to carton labeling errors. The carton labels incorrectly state 0.125 mg while the actual tablets inside contain 0.25 mg.
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: The FDA classified this recall as Class I, which per the rubric requires a minimum severity score of 4. Although no illnesses or injuries have been reported, the labeling error creates potential for medication dosing errors when providers or patients base decisions on the incorrect carton label rather than the actual tablet strength.
Plain-English summary
Endo Pharmaceuticals, Inc. is recalling 8,139 cartons of Clonazepam Orally Disintegrating Tablets, USP (C-IV) from Lot 550147301 due to labeling errors on the cartons. The cartons are labeled as containing 0.125 mg tablets; however, the actual tablets inside the blister strips contain 0.25 mg.
The affected product has an expiration date of 08/31/2026 and was distributed nationwide in the USA and Puerto Rico by Par Pharmaceutical. This labeling discrepancy could lead to medication errors if healthcare providers or patients use the incorrect carton label to determine dosing.
The recalled product
- Product
- CLONAZEPAM (CLONAZEPAM)
- Brand
- CLONAZEPAM
- Manufacturer
- Endo Pharmaceuticals, Inc.
- Category
- Drug
- Affected units
- 8,139
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 550147301
- Exp. 08/31/2026
Distribution
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