FDAClass IIJuly 26, 2023

Tizanidine Tablets USP recall: Failed Dissolution

Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC…

Why was Tizanidine Tablets USP recalled?

Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: T2100585, T2100586, T2100587, Exp 12/2023

Product
Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC…
Recalling firm
Dr Reddy's Laboratories Limited
Quantity
17,548 1000-countbottles
Distribution
Nationwide in the USA
Recall date
July 26, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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