Tizanidine Tablets Recalled Nationwide for Failed Dissolution Specification
Dr. Reddy's Laboratories is recalling Tizanidine 4 mg tablets nationwide because 24-month stability testing revealed dissolution specification failures. No illnesses or injuries have been reported.
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: This is an FDA Class II recall involving failed dissolution specifications identified through stability testing. While no illnesses or injuries have been reported, dissolution specification failure in a prescription drug represents a risk-of-harm product where therapeutic efficacy may be compromised.
Plain-English summary
Dr. Reddy's Laboratories Limited is recalling Tizanidine 4 mg tablets because stability testing revealed dissolution specification failures. Out-of-specification results were observed during 24-month long-term stability testing.
The recall affects 1,000-count bottles distributed nationwide. Affected lot numbers are T2100585, T2100586, and T2100587, with expiration date December 2023. Approximately 17,548 bottles are involved in this recall.
Patients and healthcare providers with this medication should contact the manufacturer or their pharmacy for handling instructions. No illnesses or injuries have been reported at this time.
The recalled product
- Product
- TIZANIDINE (TIZANIDINE)
- Brand
- TIZANIDINE
- Manufacturer
- Dr Reddy's Laboratories Limited
- Category
- Drug
- Hazard
- dissolution-defect
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 (4)
- Lot: T2100585
- T2100586
- T2100587
- Exp 12/2023
UPCs (2)
- 0355111180104
- 0355111179108
Distribution
Distributed nationwide across the United States.
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