CLASS II Drug recall · Reported 26 Sep 2018 · FDA Enforcement Report
Tizanidine HCl Tablets, USP 2mg recalled by Dr. Reddy's Laboratories
Dr. Reddy's Laboratories is recalling Tizanidine HCl Tablets, USP 2mg, distributed nationwide in the US. The recall was initiated on 4 Sep 2018 and the FDA has classified it as Class II.
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-1191-2018
- FDA event ID
- 80953
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Brand
- Tizanidine
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Sep 2018
- FDA classified
- 17 Sep 2018
- Reported
- 26 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 4 Sep 2018 | Recall initiated by company | |
| 17 Sep 2018 | Classified by FDA | +13 days |
| 26 Sep 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
Product as listed by the FDA
Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilakulam - 532 409 INDIA, NDC 55111-179-15, UPC 35511179153
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Tizanidine HCl Tablets, USP 2mg recalled?
Yes. Dr. Reddy's Laboratories recalled Tizanidine HCl Tablets, USP 2mg on 4 Sep 2018. The recall is Class II and its status is Terminated. Recall number D-1191-2018.
Why was it recalled?
Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
Which lots are affected?
Lot #: T800304, Exp. 03/2021
Where was it sold?
Nationwide within the United States
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 Dr. Reddy's Laboratories
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|---|---|---|---|---|---|
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| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
Other Tizanidine recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tizanidine Tablets, USP 4mg recalled by Dr. Reddy's LaboratoriesTizanidine | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS II | Tizanidine Tablets USP, 4 mg recalled by Dr Reddy's LaboratoriesTizanidine | Dr Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Tizanidine Tablets, USP, 4 mg x dose blister packs) recalledTizanidine | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS II | Tizanidine Hydrochloride Tablet 4mg recalledTizanidine | Preferred Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Tizanidine HCl Tablets, USP 4 mg recalled by Dr. Reddy's LaboratoriesTizanidine | Dr. Reddy's Laboratories | Other | Nationwide |