Drug FDA Class I Ongoing Mislabeling
Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-309-02 (carton), NDC #: 49884-309-52 (blisters).
Endo USA, Inc. Published Jan 15, 2025
Risk level
Class IDangerous or defective — could cause serious health problems or death.
Severity score 85/100
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 USA, 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. The blister strips inside the product carton reflect the correct strength.
Affected products (1)
Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-309-02 (carton), NDC #: 49884-309-52 (blisters).
CLONAZEPAM · 22,513 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, 49884-309-52
Code info: Lot #s: 550145201, Exp. 08/31/2026; 550175901, 550176001, 550176201, Exp. 02/28/2027
Affected areas
Nationwide
Timeline
- InitiatedNov 18, 2024
- PublishedJan 15, 2025
- Recall number
- D-0181-2025
- 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.