Clonazepam Tablets Recalled Due to Carton Labeling Error
Endo USA, Inc. is recalling 22,513 cartons of clonazepam tablets due to incorrect strength labeling on some carton exteriors. The actual tablets inside have correct labeling.
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 classification mandates a minimum severity score of 4. Although no illnesses or injuries have been reported, a labeling discrepancy on a controlled benzodiazepine poses a reasonable probability of medication errors.
Plain-English summary
Endo USA, Inc. is recalling 22,513 cartons of Clonazepam Orally Disintegrating Tablets, USP, 1 mg due to labeling errors on some product cartons. The exterior carton packaging on certain batches bears incorrect strength information.
The blister strips inside these cartons display the correct medication strength. The discrepancy affects only the carton exterior labeling, not the actual medication tablets themselves.
The recall affects products distributed nationwide in the USA with lot numbers 550145201 (Exp. 08/31/2026), 550175901, 550176001, and 550176201 (Exp. 02/28/2027). The affected product is distributed by PAR Pharmaceutical.
The FDA has classified this as a Class I recall, indicating that use of the product may cause serious adverse health consequences or death due to the potential for medication errors from the carton labeling discrepancy.
The recalled product
- Product
- CLONAZEPAM (CLONAZEPAM)
- Brand
- CLONAZEPAM
- Manufacturer
- Endo USA, Inc.
- Category
- Drug
- Affected units
- 22,513
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 (6)
- Lot #s: 550145201
- Exp. 08/31/2026
- 550175901
- 550176001
- 550176201
- 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 →Related recalls
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