TIROSINT levothyroxine sodium oral solution recalled for subpotency nationwide
IBSA Pharma Inc. is recalling TIROSINT (levothyroxine sodium) oral solution due to subpotency—some doses contain insufficient active ingredient. Patients should contact their pharmacist or doctor to verify their medication.
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: This is an FDA Class II recall initiated voluntarily by the firm. No illnesses or injuries are reported in the source. The subpotency issue is a precautionary quality matter managed proactively, fitting the rubric criterion for voluntary precautionary recalls.
Plain-English summary
IBSA Pharma Inc. is recalling TIROSINT (levothyroxine sodium) oral solution, 137 microgram/mL, in packages of 6 pouches x 5 ampules, distributed nationwide in the United States. The affected product includes Lot #220415 (expiration October 2023) and Lot #221052 (expiration April 2024). The FDA assigned recall number D-0343-2023.
The firm initiated this recall due to subpotency—some doses contain less active ingredient than labeled. Levothyroxine sodium is a prescription medication used to treat hypothyroidism and requires precise dosing for therapeutic effectiveness.
Patients taking TIROSINT from the affected lots should contact their pharmacist or healthcare provider to confirm their medication is not part of this recall and to discuss whether a switch to an alternative levothyroxine product is needed. Do not discontinue thyroid medication without medical guidance. The recall was initiated on January 30, 2023, and was terminated on October 31, 2023.
The recalled product
- Product
- TIROSINT (LEVOTHYROXINE SODIUM)
- Brand
- TIROSINT
- Manufacturer
- IBSA PHARMA INC
- Hazard
- subpotent-drug
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 (4)
- Lot #: 220415
- Exp. 10/2023
- 221052
- Exp. 04/2024.
UPCs (15)
- 0371858011754
- 0371858013055
- 0371858012553
- 0371858011556
- 0371858015554
- 0371858013550
- 0371858015059
- 0371858014052
- 0371858016056
- 0371858014557
- 0371858010559
- 0371858011358
- 0371858011259
- 0371858011051
- 0371858012058
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · TIROSINT
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FDA (Drugs) · 2023-03-01
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- HighFDA Recalls TIROSINT Levothyroxine Sodium Oral Solution for Subpotency
FDA (Drugs) · 2023-03-01
- HighTIROSINT Levothyroxine Sodium Oral Solution Recalled for Subpotency
FDA (Drugs) · 2023-03-01
- ModerateTIROSINT Levothyroxine Oral Solution Recalled for Subpotent Drug Content
FDA (Drugs) · 2023-03-01
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