Class II · Moderate risk
Tizanidine Tablets
Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
Tizanidine HCl Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Tablet/Capsule Specification: Some tablets are shaved
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
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.
Affected NDC
55111-0180-15
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, Inc.
- NDC code
- 55111-180-15
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0750-2021 · 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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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 Tablets USP
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Class II · Moderate risk
Tizanidine Tablets
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Other recalls by Dr. Reddy's Laboratories, Inc.
All 2021 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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