Tizanidine Tablets — Class II drug recall D-0892-2023
Terminated recall by Amerisource Health Services LLC, reported 2023-07-12, distributed nationwide. Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Labor
| Recall number | D-0892-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amerisource Health Services LLC, Columbus, OH, United States |
| Recall initiated | 2023-06-23 |
| Classified | 2023-06-30 |
| Reported by FDA | 2023-07-12 |
| Terminated | 2024-09-06 |
| Distributed | Nationwide (US) |
| Quantity | 4,971 cartons |
| Reason classes | specification failure |
| NDC | 68084-0645, 68084-0645-01, 68084-0645-11, 68084-0645-65, 68084-0775, 68084-0775-25, 68084-0775-95 |
| Lot numbers | 1004835 |
| Expiration dates | 2023-07-31 |
Product
Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-645-01 (carton), barcode (01) 003 68084 645 11 2.
Reason for recall
Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
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-0892-2023. 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.