Tizanidine 4mg Tablets Recalled for Contamination with 2mg Tablets
Dr. Reddy's Laboratories is recalling Tizanidine 4mg tablets due to the presence of 2mg tablets in bottles. About 38,952 bottles were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II product contamination with wrong-strength tablets poses a risk of harm but no illnesses or injuries have been reported, fitting the rubric criterion for 3 (High): risk-of-harm products where injury has not yet been reported.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Tizanidine (Tizanidine) 4mg tablets due to the presence of foreign tizanidine 2mg tablets.
The recalled product is Tizanidine Tablets, USP 4mg in 150-count bottles. The affected lot is #T2304007 with an expiration date of 7/31/2026. Approximately 38,952 bottles were distributed nationwide in the United States.
The contamination involves tizanidine 2mg tablets being present in bottles intended for 4mg tablets.
The recalled product
- Product
- TIZANIDINE (TIZANIDINE)
- Brand
- TIZANIDINE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug
- Hazard
- product-contamination
- wrong-dosage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: T2304007
- Exp 7/31/2026
UPCs (2)
- 0355111180104
- 0355111179108
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · TIZANIDINE
- HighTizanidine Tablets Recalled Nationwide for Failed Dissolution Specification
FDA (Drugs) · 2023-07-26
- ModerateTizanidine tablets recalled nationwide for failed stability specifications
FDA (Drugs) · 2023-07-12
- ModeratePrescription Drug Tizanidine Tablets Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2023-07-12
- ModerateTizanidine Tablets Recalled for Failed Specifications Due to Shaved Tablets
FDA (Drugs) · 2021-08-25
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27