FDA Drug recall D-0923-2023
Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India
- FDA Drug
- Class II
- ongoing
- Published 2023-07-26
On 2023-07-26 the FDA classified a Class II recall of Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India by Dr Reddy S Laboratories, citing failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0923-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-21 |
| Published | 2023-07-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
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
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Identifiers
| ndc | 55111-179-30 |
|---|---|
| ndc | 55111-179-15 |
| ndc | 55111-179-03 |
| ndc | 55111-179-10 |
| ndc | 55111-180-30 |
| ndc | 55111-180-15 |
| ndc | 55111-180-03 |
| ndc | 55111-180-10 |
| code_info | Lot: T2100585, T2100586, T2100587, Exp 12/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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All Dr Reddy S Laboratories recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0923-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.