FDA Drug recall D-1427-2012
Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged…
- FDA Drug
- Class III
- terminated
- Published 2012-08-01
On 2012-08-01 the FDA classified a Class III recall of Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged… by Stat Rx Usa, citing labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1427-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-07-23 |
| Published | 2012-08-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Stat Rx Usa |
| Distribution | US |
Product
Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged and distributed by STAT Rx USA, Gainesville, GA, NDC 16590-221-90.
Reason
Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.
Identifiers
| code_info | Lot #: 28JN1272, Exp 02/15 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1427-2012%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.