CLASS III Drug recall · Reported 1 Aug 2012 · FDA Enforcement Report
Tizanidine (Generic for: Zanaflex), 4 mg recalled by Stat Rx U
Stat Rx U is recalling Tizanidine (Generic for: Zanaflex), 4 mg per, distributed nationwide in the US. The recall was initiated on 23 Jul 2012 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1427-2012
- FDA event ID
- 62639
- Recalling firm
- Stat Rx U, Gainesville, GA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 23 Jul 2012
- FDA classified
- 26 Jul 2012
- Reported
- 1 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
Timeline
| 23 Jul 2012 | Recall initiated by company | |
| 26 Jul 2012 | Classified by FDA | +3 days |
| 1 Aug 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Is Tizanidine (Generic for: Zanaflex), 4 mg per recalled?
Yes. Stat Rx U recalled Tizanidine (Generic for: Zanaflex), 4 mg per on 23 Jul 2012. The recall is Class III and its status is Terminated. Recall number D-1427-2012.
Why was it recalled?
Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.
Which lots are affected?
Lot #: 28JN1272, Exp 02/15
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Stat Rx U
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Methocarbamol 750 mg Tablets, 90-count bottle, Mfg by: West-Ward recalled | Stat Rx U | Packaging Defects | PA |
| Drug | CLASS III | Venlafaxine ER 150mg, 30 Tabs, Generic for: Effexor, Packaged recalled | Stat Rx U | Labeling Errors | GA, TN |
| Drug | CLASS III | Tobramycin Ophthalmic Oint., 3%, (Generic for: Tobrex) recalled | Stat Rx U | Sterility | FL, PA, VA |