Liothyronine Sodium tablets recalled due to failed impurity and degradation specifications
Sun Pharmaceutical is recalling 96,192 bottles of Liothyronine Sodium Tablets nationwide due to failed quality specifications for impurities and degradation. The affected lots were distributed in 100-count bottles.
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 2/5 (Moderate).
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 with no reported illnesses or injuries. The recall is based on failed quality control specifications (impurities and degradation), classified as a precautionary measure.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling 96,192 bottles of Liothyronine Sodium Tablets, USP 5 mcg, nationwide. The recall affects lot numbers DND0059A through DND0184A with expiration dates ranging from December 2023 through February 2024.
The tablets were recalled because they failed to meet quality specifications for impurities and degradation. The product was manufactured by Sun Pharmaceutical Industries Ltd. in India and distributed by Sun Pharmaceutical Industries Inc. located in Cranbury, New Jersey.
The recalled product
- Product
- LIOTHYRONINE SODIUM (LIOTHYRONINE SODIUM)
- Brand
- LIOTHYRONINE SODIUM
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Hazard
- Affected units
- 96,192
Distribution
Distributed nationwide across the United States.
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