Drug FDA Class I Terminated Mislabeling
Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02.
Endo Pharmaceuticals, Inc. Published Aug 7, 2024
Risk level
Class IDangerous or defective — could cause serious health problems or death.
Severity score 80/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Endo Pharmaceuticals, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.
Affected products (1)
Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02.
CLONAZEPAM · 8,139 cartons
NDC: 49884-306, 49884-307, 49884-308, 49884-309, 49884-310, 49884-306-02, 49884-307-02, 49884-308-02, 49884-309-02, 49884-310-02
Lot codes: 550147301
Code info: Lot 550147301, Exp. 08/31/2026
Affected areas
Nationwide
Timeline
- InitiatedJul 10, 2024
- PublishedAug 7, 2024
- TerminatedSep 16, 2025
- Recall number
- D-0622-2024
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.