Endo USA, Inc. has initiated a nationwide voluntary recall of Clonazepam Orally Disintegrating Tablets due to labeling errors that could lead to potentially dangerous dosage confusion.
The recall, classified as Class I by the U.S. Food and Drug Administration (FDA), affects four variations of the prescription medication distributed by PAR Pharmaceutical.
A Class I recall is issued when is a reasonable probability that the use of, or exposure to the recalled product will cause serious adverse health consequences or death.
The mislabeled products remain ongoing, with the initial recall initiated on November 18, 2024.
Products Affected
1. Clonazepam Orally Disintegrating Tablets, USP, 2 mg (C-IV)
- Recall Number: D-0178-2025
- Lot Numbers: 550176501, 550176601
- Expiration Date: 02/28/2027
- Quantity: 9,816 cartons
2. Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg (C-IV)
- Recall Number: D-0179-2025
- Lot Number: 550174101
- Expiration Date: 01/31/2027
- Quantity: 8,029 cartons
3. Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg (C-IV)
- Recall Number: D-0180-2025
- Lot Numbers: 550142801 to 550143401, 550147201, 550147401
- Expiration Date: 08/31/2026
- Quantity: 72,973 cartons
4. Clonazepam Orally Disintegrating Tablets, USP, 1 mg (C-IV)
- Recall Number: D-0181-2025
- Lot Numbers: 550145201, 550175901 to 550176201
- Expiration Dates: 08/31/2026 to 02/28/2027
- Quantity: 22,513 cartons
Reason for Recall
Some cartons were incorrectly labeled regarding the tablet strength, although the blister strips inside reflect the correct strength. This discrepancy could lead to accidental overdose or underdose.
Inadvertent prescription of a two-fold overdose could pose severe risks to patients, including significant sedation, dizziness, ataxia (loss of muscle control), and confusion.
More critically, patients may experience life-threatening respiratory depression. This risk is heightened for individuals with pre-existing pulmonary disease, those taking near-maximal doses, or those concurrently using medications that can depress respiratory function.
Despite the severity of the potential health risks, Endo USA has not received any reports of adverse events linked to this recall.
The products were distributed nationwide. Endo USA issued a press release on November 18, 2024, advising healthcare providers and pharmacies to check their inventory and return any mislabeled products immediately.
For more details, visit the FDA recall page here.