Tizanidine Tablets — Class II drug recall D-0173-2021
Terminated recall by Ascend Laboratories LLC, reported 2020-12-09, distributed in MI. Failed Dissolution Specifications; Out of Specification (low) results were obtained.
| Recall number | D-0173-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascend Laboratories LLC, Parsippany, NJ, United States |
| Recall initiated | 2020-11-24 |
| Classified | 2020-12-22 |
| Reported by FDA | 2020-12-09 |
| Terminated | 2023-04-11 |
| Distributed | MI |
| Quantity | 1,200 bottles |
| Reason classes | specification failure |
| NDC | 67877-0613, 67877-0613-05, 67877-0613-15, 67877-0614, 67877-0614-05, 67877-0614-15 |
| Lot numbers | 19143017 |
| Expiration dates | 2021-05-31 |
Product
Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC: 67877-614-15.
Reason for recall
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0173-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.