Tizanidine 4mg Tablets (Stat Rx USA) – Label Mix-Up (2012)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Stat Rx USA
Lot Codes / Batch Numbers
Lot #: 28JN1272, Exp 02/15
Products Sold
Lot #: 28JN1272, Exp 02/15
Stat Rx USA is recalling Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs L due to Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026