CLASS II ONGOING Drug recall · Reported 26 Jul 2023 · FDA Enforcement Report
Tizanidine Tablets USP, 4 mg recalled by Dr Reddy's Laboratories
Dr Reddy's Laboratories is recalling Tizanidine Tablets USP, 4 mg, distributed nationwide in the US. The recall was initiated on 21 Jun 2023 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-0923-2023
- FDA event ID
- 92564
- Recalling firm
- Dr Reddy's Laboratories, Ranasthalam Mandal, Srikakulam, N/A
- Brand
- Tizanidine
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Jun 2023
- FDA classified
- 17 Jul 2023
- Reported
- 26 Jul 2023
- Type
- N/A
- Customers notified by
- N/A
- Reason category
- Potency & Assay
Timeline
| 21 Jun 2023 | Recall initiated by company | |
| 17 Jul 2023 | Classified by FDA | +26 days |
| 26 Jul 2023 | 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
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Tizanidine Tablets USP, 4 mg recalled?
Yes. Dr Reddy's Laboratories recalled Tizanidine Tablets USP, 4 mg on 21 Jun 2023. The recall is Class II and its status is Ongoing. Recall number D-0923-2023.
Why was it recalled?
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Which lots are affected?
Lot: T2100585, T2100586, T2100587, Exp 12/2023
Where was it sold?
Nationwide in the USA
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
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 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 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 |
| Drug | CLASS II | Tizanidine Tablets, USP 4mg recalled by Ascend LaboratoriesTizanidine | Ascend Laboratories | Potency & Assay | MI |