CLASS II ONGOING Drug recall · Reported 12 Jul 2023 · FDA Enforcement Report
Tizanidine Hydrochloride Tablet 4mg recalled
Preferred Pharmaceuticals is recalling Tizanidine Hydrochloride Tablet 4mg, distributed nationwide in the US. The recall was initiated on 26 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-0894-2023
- FDA event ID
- 92625
- Recalling firm
- Preferred Pharmaceuticals, Anaheim, CA
- Brand
- Tizanidine
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Jun 2023
- FDA classified
- 5 Jul 2023
- Reported
- 12 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 26 Jun 2023 | Recall initiated by company | |
| 5 Jul 2023 | Classified by FDA | +9 days |
| 12 Jul 2023 | 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 Stability Specifications
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 Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-count bottles, (NDC: 68788-7781-6), d) 90-count bottles (NDC: 68788-7781-9), e) 120-count bottles (NDC: 68788-7781-8), Rx only, Mfg: Dr. Reddy's Laboratories Limited.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Failed Stability Specifications
Which lots are affected?
Lot#: a) H1621S, Exp: 12/31/2023; b) H2321C, Exp: 12/31/2023; c) H0421B, Exp: 12/31/2023; d) H1721E, H1921T, H3121M, Exp: 12/31/2023, e) H2021G, Exp: 12/31/2023
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 Preferred Pharmaceuticals
All 55| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Artificial Tears Lubricant Eye Drops (glycerin recalledArtificial Tears | Preferred Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Ondansetron ODT Tablets, USP 4mg, unit dose tablets, Mfg recalled | Preferred Pharmaceuticals | Packaging Defects | CA |
| Drug | CLASS II | Clindamycin Hydrochloride Capsules, USP, 300mg recalled | Preferred Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size recalled | Preferred Pharmaceuticals | Potency & Assay | CA, NV |
| Drug | CLASS II | Duloxetine Delayed-Release Cap USP 30mg recalled | Preferred Pharmaceuticals | Nitrosamine Impurity | 5 states |
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 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 |