Liothyronine Sodium Tablets Recalled for Failed Impurity and Degradation Specifications
Sun Pharmaceutical is recalling 7,392 bottles of Liothyronine Sodium Tablets (Lot DND0058A) nationwide due to failed impurity and degradation specifications. Patients should contact their healthcare provider.
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: FDA Class II recall with no reported illnesses or injuries. Impurities or degradation in a prescription thyroid medication represents a risk-of-harm scenario, meeting the criterion for High severity despite the absence of documented harm.
Plain-English summary
Sun Pharmaceutical Industries Inc is recalling 7,392 bottles of Liothyronine Sodium Tablets, USP, 5 mcg (NDC 62756-589-88, Lot DND0058A, expiration 12/2023) due to failed impurity and degradation specifications. The tablets were manufactured by Sun Pharmaceutical Industries Ltd in India and distributed nationwide in the United States.
The recall affects patients who have been prescribed tablets from the affected lot. Liothyronine Sodium is a prescription thyroid hormone medication.
Patients currently taking tablets from the recalled lot should contact their healthcare provider for guidance. Consumers with unused tablets from this lot should not use them and should consult their healthcare provider or pharmacist about proper disposal.
The recalled product
- Product
- LIOTHYRONINE SODIUM (LIOTHYRONINE SODIUM)
- Brand
- LIOTHYRONINE SODIUM
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Thyroid Hormone
- Hazard
- Affected units
- 7,392
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 #: DND0058A
- Exp. Date 12/2023
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
Same brand · LIOTHYRONINE SODIUM
- ModerateLiothyronine Sodium tablets recalled due to failed impurity and degradation specifications
FDA (Drugs) · 2023-12-20
- HighLiothyronine Sodium Tablets Recalled for Failed Impurity Specifications
FDA (Drugs) · 2023-11-08
- ModerateSigmaPharm Recalls Liothyronine Sodium Tablets Due to Cross-Contamination
FDA (Drugs) · 2014-05-28
Same manufacturer · SUN PHARMACEUTICAL INDUSTRIES INC
See all →- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Specifications
FDA (Drugs) · 2026-10-14
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08
Same hazard · impurity
See all →- ModerateAjanta Pharma Recalls Fluphenazine Hydrochloride Tablets Due to Impurity Failure
FDA (Drugs) · 2026-09-16
- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
Similar recalls
- ModerateLiothyronine Sodium tablets recalled due to failed impurity and degradation specifications
FDA (Drugs) · 2023-12-20
- HighLevothyroxine Sodium tablets recalled for impurity specification failure
FDA (Drugs) · 2025-01-08
- ModerateMayne Pharma Recalls Liothyronine Sodium Tablets for Dissolution Failures
FDA (Drugs) · 2017-12-06
- ModerateLevothyroxine Sodium Tablets Recalled for Subpotency by Accord Healthcare
FDA (Drugs) · 2025-05-07
- LowLiothyronine Sodium Tablets Recalled for Failed Stability Testing
FDA (Drugs) · 2013-05-15
- HighLevothyroxine Sodium Tablets recalled nationwide for potency failures
FDA (Drugs) · 2024-12-18