Stat Rx Tizanidine Recall: FDA Class III

Why it was recalled

Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.

Product description

Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged and distributed by STAT Rx USA, Gainesville, GA, NDC 16590-221-90.

Lot numbers, UPCs & expiration codes

Lot #: 28JN1272, Exp 02/15

Where it was sold

Nationwide

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-1427-2012
Classification: Class III
Status: Terminated
Recall initiated: Jul 23, 2012
FDA report date: Aug 1, 2012
Quantity: 51 Bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Stat Rx USA

Original FDA data

Every field from FDA enforcement report D-1427-2012, exactly as published.

Show all FDA fields

City: Gainesville
State: GA
Status: Terminated
Country: United States
Event ID: 62639
Address: 2481 Hilton Dr
Code information: Lot #: 28JN1272, Exp 02/15
Postal code: 30501-6213
Report date: Aug 1, 2012
Product type: Drugs
Recall number: D-1427-2012
Classification: Class III
Recalling firm: Stat Rx USA
Product quantity: 51 Bottles
Termination date: Jan 31, 2013
Reason for recall: Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged and distributed by STAT Rx USA, Gainesville, GA, NDC 16590-221-90.
Distribution pattern: Nationwide
Recall initiation date: Jul 23, 2012
Initial firm notification: E-Mail
Center classification date: Jul 26, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1427-2012, published Aug 1, 2012. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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.

Stat Rx Tizanidine Recall

Summary