Levothyroxine Sodium Tablets Recalled for Out-of-Specification Potency
Mylan Institutional is recalling Levothyroxine Sodium Tablets 150 mcg due to out-of-specification potency. The medication tested higher than specified, affecting 347 cartons distributed nationwide (Lot 3116074, expires 09/30/2025).
What this means for you
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 drug recall with out-of-specification potency identified. No reported illnesses or hospitalizations. Qualifies as a risk-of-harm product where injury has not yet been reported, per rubric Score 3 criteria.
Plain-English summary
Mylan Institutional, Inc. is recalling Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), in 100 Unit Dose Blister Cards format. The recall affects 347 cartons distributed nationwide.
The recall was initiated due to out-of-specification potency results. Testing showed the tablets contained higher potency than specified. The affected lot is 3116074, with an expiration date of September 30, 2025. The product was manufactured in India.
Patients taking this medication should contact their pharmacy or healthcare provider regarding this recall. Patients should not discontinue levothyroxine, a critical thyroid hormone, without guidance from their healthcare provider.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- Mylan Institutional, Inc.
- Category
- Drug
- Hazard
- out-of-specification
- super-potency
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 3116074
- Exp. 09/30/2025
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · LEVOTHYROXINE SODIUM
- HighFDA Recalls Super-Potent Levothyroxine Sodium Tablets Due to Potency Deviation
FDA (Drugs) · 2025-03-26
- HighLevothyroxine Sodium tablets recalled for impurity specification failure
FDA (Drugs) · 2025-01-08
- HighLevothyroxine Sodium Tablets Recalled Due to Potency Failures
FDA (Drugs) · 2024-12-18
- HighLevothyroxine Sodium Tablets Recalled Due to Potency Failures
FDA (Drugs) · 2024-12-18
- HighDrug Recall: Levothyroxine Sodium Tablets Affected by Potency Failures
FDA (Drugs) · 2024-12-18
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- SevereErythromycin Tablets Recalled for Impurity Above Acceptable Limits
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- ModeratePrimidone Tablets Recalled Due to API Cross-Contamination
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27