Endo, Inc announced that one of its operating subsidiaries, Endo USA, Inc., is voluntarily recalling one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25mg tablets, which may also appear as Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg tablets 60-count pack to the consumer level.
The product lot is being recalled due to mislabeling where an incorrect strength appears on the cartons of some packs to show the product strength as 0.125mg and not 0.25mg due to an error at a third-party packager. The blister strips inside the product pack reflect the correct strength of 0.25mg.
This recall impacts the following product lot:
- See below image of correct carton label: Clonazepam Orally Disintegrating Tablets, USP 0.25mg 60-count carton, lot 550147301, expiration date August 2026
- See below image of incorrect carton label: Clonazepam Orally Disintegrating Tablets, USP 0.125mg
60-count carton, lot 550147301, expiration date August 2026
(Note: No BeneCard PBF members were affected by this recall.)
Source: FDA
