CLASS II Drug recall · Reported 25 Aug 2021 · FDA Enforcement Report
Tizanidine HCl Tablets, USP 4 mg recalled by Dr. Reddy's Laboratories
Dr. Reddy's Laboratories is recalling Tizanidine HCl Tablets, USP 4 mg, distributed nationwide in the US. The recall was initiated on 19 Jul 2021 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-0750-2021
- FDA event ID
- 88309
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Brand
- Tizanidine
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Jul 2021
- FDA classified
- 18 Aug 2021
- Reported
- 25 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 19 Jul 2021 | Recall initiated by company | |
| 18 Aug 2021 | Classified by FDA | +30 days |
| 25 Aug 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specification: Some tablets are shaved
Product as listed by the FDA
Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam District, 532 409 INDIA, NDC 55111-180-15.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specification: Some tablets are shaved
Which lots are affected?
Lot #: T2000471, exp date 09/2023
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 26 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
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| 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 0.75% 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 12| 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 Tablets, USP 4mg recalled by Ascend LaboratoriesTizanidine | Ascend Laboratories | Potency & Assay | MI |