The Recall Desk
ModerateFDA (Drugs)·D-0150-2024·Announced 2023-12-20

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.

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 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
  • impurities
  • degradation

Distribution

Distributed nationwide across the United States.