Reported Jul 26, 2023 · Ongoing

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

Dr Reddy's Laboratories Limited

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Dr Reddy's Laboratories Limited · Fto-Sez Unit 1, Surv. 57-59,60, 62 & 72 · Ranasthalam Mandal, Srikakulam, N/A · N/A

Is this the product you have?

  • Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10
Lot codes and dates
  • Lot
    • T2100585
    • T2100586
    • T2100587
    • Exp 12/2023
Amount recalled
17,548 1000-countbottles

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 8:08 PM UTC

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