Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd. Mumbai, India, Dist. by: Sun Pharmaceutical Industries In., Cranbury, NJ 08512, NDC 57664-783-68, packaged in bottles.

FDA recall notice · announced June 29, 2022 · Sun Pharmaceutical Industries

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

Failed Tablet/Capsule Specification; oversized tablet found in a bottle

Notes

Distribution: nationwide within the United States
Lot/code information: Lot #: MHC1430A, Exp. Date 09/2023
Quantity: 4608 bottles
Status: Terminated
Products in this recall event:
- Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd. Mumbai, India, Dist. by: Sun Pharmaceutical Industries In., Cranbury, NJ 08512, (D-1155-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.