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Class II · ModerateActive recall

Tizanidine

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot: T2100585, T2100586, T2100587, Exp 12/2023
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byDr. Reddy's Laboratories Limited Srikakulam - 532 409 India foreign manufacturer
Brand nameTIZANIDINE
Generic nameTIZANIDINE
Active ingredient(s)TIZANIDINE HYDROCHLORIDE
Distributed by / forDr Reddy's Laboratories Limited
NDC55111-180-10
Show the full FDA record
Full product labelTizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10
Recalling firmDr Reddy's Laboratories Limited
DistributionNationwide in the USA
Quantity17,548 1000-countbottles
Recall initiated2023-06-21
Report date2023-07-26
Recall completed—
Recall numberD-0923-2023
ClassificationClass II
FDA statusOngoing
Origin on fileRanasthalam Mandal, Srikakulam N/A India

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.