Cardinal Health Recalls Levothyroxine Sodium Tablets Due to Temperature Excursions
Cardinal Health Inc. is recalling 112 bottles of Levothyroxine Sodium Tablets due to intermittent temperature excursions during storage.
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: The recall is classified as FDA Class II, and the hazard involves storage conditions (temperature excursions) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Cardinal Health Inc. is recalling 112 bottles of Levothyroxine Sodium Tablets, USP 125 mcg (0.125 mg), 90-count bottles. The product is identified by NDC 0378-1813-77 and code 3109046. The recall was initiated due to Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.
The affected product was distributed in Florida, Georgia, and South Carolina. The manufacturer of record is Mylan Pharmaceuticals Inc., located in Morgantown, WV.
Consumers who have this product should contact their healthcare provider or pharmacist for guidance on whether to discontinue use or obtain a replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 112
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 (1)
- 3109046
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health 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.
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