Cardinal Health Recalls TIROSINT Capsules Due to Temperature Excursions
Cardinal Health is recalling 25 boxes of TIROSINT (levothyroxine sodium) capsules due to intermittent temperature excursions during storage.
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 2/5 (Moderate).
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 a moderate severity precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 25 boxes of TIROSINT (levothyroxine sodium) capsules, 175 mcg, NDC 71858-0055-4. The recall was initiated due to CGMP deviations involving intermittent exposure to temperature excursions during storage.
The affected product was distributed in Florida, Georgia, and South Carolina. The specific lot code for the recalled units is 200606.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.
The recalled product
- Product
- TIROSINT (LEVOTHYROXINE SODIUM)
- Brand
- TIROSINT
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Thyroid Hormone
- Affected units
- 25
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)
- 200606
UPCs (15)
- 0371858005548
- 0371858005043
- 0371858006040
- 0371858001540
- 0371858003544
- 0371858001243
- 0371858003049
- 0371858001045
- 0371858001748
- 0371858004046
- 0371858001342
- 0371858000543
- 0371858002547
- 0371858004541
- 0371858002042
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.
See all 198 products in this recall →Related recalls
Same brand · TIROSINT
- ModerateTIROSINT levothyroxine sodium oral solution recalled for subpotency nationwide
FDA (Drugs) · 2023-03-01
- HighFDA Recalls TIROSINT Levothyroxine Sodium Oral Solution for Subpotency
FDA (Drugs) · 2023-03-01
- HighLevothyroxine Oral Solution TIROSINT Recalled Due to Subpotency
FDA (Drugs) · 2023-03-01
- HighPrescription drug TIROSINT levothyroxine recalled for subpotent formulation
FDA (Drugs) · 2023-03-01
- HighTIROSINT Levothyroxine Sodium Oral Solution Recalled for Subpotency
FDA (Drugs) · 2023-03-01
Same manufacturer · Cardinal Health Inc.
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