FDA Drug recall D-0894-2023
Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-coun…
- FDA Drug
- Class II
- ongoing
- Published 2023-07-12
On 2023-07-12 the FDA classified a Class II recall of Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-coun… by Preferred Pharmaceuticals, citing failed Stability Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0894-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-26 |
| Published | 2023-07-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Preferred Pharmaceuticals |
| Distribution | US |
Product
Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-count bottles, (NDC: 68788-7781-6), d) 90-count bottles (NDC: 68788-7781-9), e) 120-count bottles (NDC: 68788-7781-8), Rx only, Mfg: Dr. Reddy's Laboratories Limited.
Reason
Failed Stability Specifications
Identifiers
| ndc | 68788-7781-2 |
|---|---|
| ndc | 68788-7781-3 |
| ndc | 68788-7781-6 |
| ndc | 68788-7781-9 |
| ndc | 68788-7781-1 |
| ndc | 68788-7781-8 |
| code_info | Lot#: a) H1621S, Exp: 12/31/2023; b) H2321C, Exp: 12/31/2023; c) H0421B, Exp: 12/31/2023; d) H1721E, H1921T, H3121M, Exp: 12/31/2023, e) H2021G, Exp: 12/31/2023 |
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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FDA Drug · Class II · 2024-09-04 · Preferred Pharmaceuticals
All Preferred Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0894-2023%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.