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
- Hazard
- label-error
- strength-mislabeling
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.
Related recalls
Same brand · CLONAZEPAM
- CriticalClonazepam Orally Disintegrating Tablets Carton Mislabeled on Declared Strength
FDA (Drugs) · 2025-01-15
- SevereClonazepam tablets recalled for incorrect carton labeling
FDA (Drugs) · 2025-01-15
- SevereClonazepam Tablets Recalled Due to Incorrect Carton Labeling
FDA (Drugs) · 2025-01-15
- SevereClonazepam Tablets Recalled Due to Carton Labeling Error
FDA (Drugs) · 2024-08-07
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27