Class II · Moderate risk
Tizanidine Tablets
Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
Tizanidine Tablets USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
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
Affected NDC
55111-0180-10
Compare with the code on your package — it is the most precise check available.
Drug: Tizanidine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Tizanidine NDC 55111-0180 |
HYDROCHLORIDE 4 mg/1 | Tablet Oral |
Dr. Reddy's Laboratories Limited | Rx |
- Recalling firm
- Dr Reddy's Laboratories Limited
- NDC code
- 55111-180-10
- Origin
- N/A, India
- Initiated by
- N/A
- FDA recall number
- D-0923-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Tizanidine recalls
See all
Class II · Moderate risk
Tizanidine Hydrochloride Tablet 4mg
Failed Stability Specifications
Class II · Moderate risk
Tizanidine Tablets
Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
Class II · Moderate risk
Tizanidine HCl Tablets
Failed Tablet/Capsule Specification: Some tablets are shaved
Class II · Moderate risk
Tizanidine Tablets
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Other recalls by Dr Reddy's Laboratories Limited
All 2023 recalls
Class III · Low risk
Varenicline Tablets
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Class II · Moderate risk
Succinylcholine Chloride Injection
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Class II · Moderate risk
Omeprazole Delayed-release Capsules
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Class I · High risk
Levetiracetam 0.75% in Sodium Chloride Injection 1
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
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