Dr. Reddy's Recalls Tizanidine Tablets Due to Foreign Glimepiride Contamination
Dr. Reddy's is recalling Tizanidine HCl tablets because a foreign Glimepiride tablet was found in a bottle. Consumers should stop using the product and contact their pharmacist.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall is classified as FDA Class II, and the hazard involves the presence of a foreign medication (Glimepiride) in a Tizanidine bottle, which presents a risk of harm through unintended ingestion, though no specific injuries are reported in the source text.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Tizanidine HCl Tablets, USP 2mg, 150-count bottles. The recall was initiated because a foreign Glimepiride tablet was found in a bottle of Tizanidine HCl Tablets. The affected product is identified by Lot # T800304 with an expiration date of 03/2021. A total of 8,376 units were distributed nationwide within the United States.
The presence of a foreign medication in the bottle poses a risk of unintended drug intake. Consumers who have purchased this specific lot of Tizanidine HCl Tablets should stop using the product immediately. They should contact their pharmacist or healthcare provider for guidance on how to dispose of the medication or obtain a replacement.
The recalled product
- Product
- TIZANIDINE (TIZANIDINE)
- Brand
- TIZANIDINE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 8,376
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 #: T800304
- Exp. 03/2021
UPCs (2)
- 0355111180104
- 0355111179108
Distribution
Distributed nationwide across the United States.
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