FDA Drugs recall ·
Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0181-2025
- Date
- (initiated November 18, 2024)
- Company / brand
- Endo USA, Inc.
1400 Atwater Dr, Malvern, PA, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 22,513 cartons
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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).
Why was it recalled?
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #s: 550145201, Exp. 08/31/2026; 550175901, 550176001, 550176201, Exp. 02/28/2027
Distribution
Nationwide in the USA
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0181-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.