Liothyronine Sodium Tablets Recalled for Failed Impurity Specifications
Sun Pharmaceutical is recalling approximately 2,304 bottles of Liothyronine Sodium Tablets, USP, 25 mcg (lot DNC2204A) due to failed impurity and degradation specifications. The affected medication was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a prescription medication due to failed impurity and degradation specifications. No illnesses or injuries have been reported. The hazard represents a risk-of-harm product where quality standards were not met, fitting the High severity category per the rubric.
Plain-English summary
Sun Pharmaceutical Industries Inc is recalling Liothyronine Sodium Tablets, USP, 25 mcg from lot DNC2204A (expiration date 11/2023) due to failed impurities and degradation specifications. Approximately 2,304 bottles of the medication were affected by this recall.
Liothyronine Sodium is a prescription medication used to treat thyroid conditions. The recall was initiated because the affected lot failed to meet established quality standards for impurities and degradation, meaning the medication may not perform as intended or could contain unintended substances.
The affected medication was distributed nationwide within the United States. Patients taking Liothyronine Sodium should verify the lot number (DNC2204A) and expiration date on their medication. Anyone with the affected lot should contact their healthcare provider or pharmacist for guidance before continuing use.
The recalled product
- Product
- LIOTHYRONINE SODIUM (LIOTHYRONINE SODIUM)
- Brand
- LIOTHYRONINE SODIUM
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Hazard
- Affected units
- 2,304
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 #: DNC2204A
- Exp. Date 11/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by SUN PHARMACEUTICAL INDUSTRIES INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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