Tizanidine Tablets USP — Class II drug recall D-0923-2023
Ongoing recall by Dr Reddy's Laboratories Limited, reported 2023-07-26, distributed nationwide. Failed dissolution specification: Out of specification results observed in 24-month long term stability testin
| Recall number | D-0923-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Recalling firm | Dr Reddy's Laboratories Limited, Ranasthalam Mandal, Srikakulam, N/A, India |
| Recall initiated | 2023-06-21 |
| Classified | 2023-07-17 |
| Reported by FDA | 2023-07-26 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 55111-0179, 55111-0179-03, 55111-0179-10, 55111-0179-15, 55111-0179-30, 55111-0180, 55111-0180-03, 55111-0180-10, 55111-0180-15, 55111-0180-30 |
| Lot numbers | T2100585, T2100586, T2100587 |
| Expiration dates | 2023-12 |
Product
Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10
Reason for recall
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
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-0923-2023. 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.