FDA Recalls Levothyroxine and Liothyronine Thyroid Tablets Due to Content Uniformity Failures
Westminster Pharmaceuticals is recalling Levothyroxine and Liothyronine tablets because they failed content uniformity specifications, potentially resulting in incorrect drug strength.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class I recall for Levothyroxine and Liothyronine (Thyroid Tablets, USP), 2 grain (120 mg), 100-count bottles. The product is manufactured for Westminster Pharmaceuticals, LLC, and is available by prescription only. The recall covers specific lots: 15817VP-01, 15817VP-02, 15817VP-03 (Exp 9/30/2019) and 15818001 (Exp 3/31/2020).
The recall was initiated because the product was manufactured using an adulterated active pharmaceutical ingredient. Additionally, a lack of process controls and good manufacturing practices resulted in the finished product failing content uniformity specifications. This failure means the tablets may have a strength that is more or less than what is labeled on the bottle.
The affected products were distributed nationwide in the USA and Puerto Rico. Patients taking this medication should consult their healthcare provider for alternative treatment options and stop using the recalled product if advised by their provider.
The recalled product
- Product
- Levothyroxine and Liothyronine (Thyroid Tablets, USP), 2 grain (120 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-158-04.
- Manufacturer
- Westminster Pharmaceuticals LLC
- Category
- Drug — Prescription Medication
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 (6)
- Lot #: 15817VP-01
- 15817VP-02
- 15817VP-03
- Exp 9/30/2019
- 15818001
- Exp 3/31/2020.
Distribution
Part of a larger recall action
This product is one of 5 recalled by Westminster Pharmaceuticals LLC 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 5 products in this recall →Related recalls
Same manufacturer · Westminster Pharmaceuticals LLC
See all →- HighMetoprolol tartrate tablets recalled for nitrosamine above acceptable daily intake level
FDA (Drugs) · 2025-08-20
- HighMetoprolol tartrate 100 mg tablets exceed the nitrosamine daily intake level
FDA (Drugs) · 2025-08-20
- SevereWestminster Irbesartan Tablets Recalled Due to NDEA Impurity
FDA (Drugs) · 2018-12-19
- SevereWestminster Irbesartan Tablets Recalled Due to NDEA Impurity Traces
FDA (Drugs) · 2018-12-19
- SevereWestminster Irbesartan Tablets Recalled Due to NDEA Impurity Traces
FDA (Drugs) · 2018-12-19
Same hazard · content uniformity
See all →- ModerateLupin Recalls Clobetasol Propionate Cream for Content Uniformity Failures
FDA (Drugs) · 2026-09-02
- HighOral contraceptive tablets recalled after failing content uniformity specifications
FDA (Drugs) · 2025-10-15
- HighCefixime Oral Suspension Recalled for Failed Content Uniformity Specifications
FDA (Drugs) · 2024-06-26
- SevereFDA Recalls Phenytoin Oral Suspension Due to Content Uniformity Failure
FDA (Drugs) · 2023-12-27
- ModerateDofetilide Capsules Recalled Due to Out-of-Specification Content Uniformity
FDA (Drugs) · 2023-08-16