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Class II: temporary or reversible health riskOngoing

Dr Reddy's Laboratories Tizanidine Tablets Recall

Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr

Dr Reddy's Laboratories Limited · Ranasthalam Mandal, Srikakulam, N/A

Risk level
Class II
Reported by FDA
Jul 26, 2023
Recall ID
D-0923-2023
Check your lot numberHow we source this data

Summary

Dr Reddy's Laboratories recalled Tizanidine Tablets starting Jun 21, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0923-2023 on Jul 26, 2023. Reason: Failed dissolution specification: Out of specification results observed in 24-month long term stability testing. Status: Ongoing.

Why it was recalled

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

Product description

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 numbers, UPCs & expiration codes

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

Where it was sold

Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0923-2023
Classification
Class II
Status
Ongoing
Recall initiated
Jun 21, 2023
FDA report date
Jul 26, 2023
Quantity
17,548 1000-countbottles
Recall type
N/A
Recalling firm
Dr Reddy's Laboratories Limited

Original FDA data

Every field from FDA enforcement report D-0923-2023, exactly as published.

Show all FDA fields
City
Ranasthalam Mandal, Srikakulam
Status
Ongoing
Country
India
Event ID
92564
Address
Fto-Sez Unit 1, Surv. 57-59,60, 62 & 72
Address (line 2)
Sect. 9-14, 17-20, Devunipalavalasa
Code information
Lot: T2100585, T2100586, T2100587, Exp 12/2023
Report date
Jul 26, 2023
Product type
Drugs
Recall number
D-0923-2023
Classification
Class II
Recalling firm
Dr Reddy's Laboratories Limited
Product quantity
17,548 1000-countbottles
Reason for recall
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Product description
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
Distribution pattern
Nationwide in the USA
Recall initiation date
Jun 21, 2023
Center classification date
Jul 17, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0923-2023, published Jul 26, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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