Prescription Drug Tizanidine Tablets Recalled for Failed Dissolution Specifications
Amerisource Health Services LLC recalls approximately 4,971 cartons of Tizanidine Tablets due to failed dissolution specifications. Tablets that do not dissolve properly may not provide intended therapeutic benefit.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall without reported illnesses or injuries. The recall is due to failed dissolution specifications, representing a manufacturing quality defect with no reported adverse health outcomes.
Plain-English summary
Amerisource Health Services LLC, through American Health Packaging, is recalling Tizanidine Tablets, USP 4 mg due to out-of-specification dissolution test results. The affected product consists of approximately 4,971 cartons, each containing 100 tablets in 10-unit dose blister packs (NDC 68084-645-01).
The tablets were found to be out of specification for dissolution testing. Tablets that do not meet dissolution specifications may not dissolve properly when ingested, which could reduce their therapeutic effectiveness.
The recalled product was distributed nationwide throughout the United States. The specific affected lot is Lot 1004835 with an expiration date of July 31, 2023.
If you have this medication, contact your healthcare provider or pharmacy immediately. Do not stop taking the medication without consulting your healthcare provider first.
The recalled product
- Product
- TIZANIDINE (TIZANIDINE)
- Brand
- TIZANIDINE
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug — Muscle Relaxant
- Hazard
- failed-dissolution
- therapeutic-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 1004835
- Exp 7/31/2023
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · TIZANIDINE
- HighTizanidine 4mg Tablets Recalled for Contamination with 2mg Tablets
FDA (Drugs) · 2024-01-17
- HighTizanidine Tablets Recalled Nationwide for Failed Dissolution Specification
FDA (Drugs) · 2023-07-26
- ModerateTizanidine tablets recalled nationwide for failed stability specifications
FDA (Drugs) · 2023-07-12
- ModerateTizanidine Tablets Recalled for Failed Specifications Due to Shaved Tablets
FDA (Drugs) · 2021-08-25
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27