Levothyroxine sodium oral solution recalled nationwide for subpotent dosing
IBSA Pharma is recalling TIROSINT levothyroxine sodium oral solution nationwide due to subpotent drug content. The recall affects lots 220413 and 220964.
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 recall with confirmed subpotency (insufficient active ingredient). No illnesses or injuries reported, but subpotent thyroid replacement medication poses a risk of harm to patients dependent on adequate dosing.
Plain-English summary
IBSA Pharma Inc. is recalling TIROSINT levothyroxine sodium oral solution (100 microgram/mL) nationwide. The recall affects specific lots of the prescription thyroid replacement medication that contain less active ingredient than labeled.
The affected lots are: Lot 220413 (expiration 10/2023) and Lot 220964 (expiration 3/2024). The product was distributed nationwide in the USA. IBSA Pharma initiated this voluntary recall on January 30, 2023, which the FDA formally classified on April 4, 2023.
Levothyroxine sodium is a thyroid replacement medication. Because the recalled lots are subpotent (containing less active ingredient than stated), they may not provide adequate thyroid hormone replacement in patients who depend on this medication.
This recall 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 #: 220413
- Exp. 10/2023
- 220964
- Exp. 3/2024.
UPCs (15)
- 0371858011754
- 0371858013055
- 0371858012553
- 0371858011556
- 0371858015554
- 0371858013550
- 0371858015059
- 0371858014052
- 0371858016056
- 0371858014557
- 0371858010559
- 0371858011358
- 0371858011259
- 0371858011051
- 0371858012058
Distribution
Distributed nationwide across the United States.
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Same brand · TIROSINT
- ModerateTIROSINT Levothyroxine Oral Solution Recalled for Subpotent Drug Content
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- HighLevothyroxine sodium oral solution recalled due to subpotency
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- HighPrescription drug TIROSINT levothyroxine recalled for subpotent formulation
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- HighFDA Recalls TIROSINT Levothyroxine Sodium Oral Solution for Subpotency
FDA (Drugs) · 2023-03-01
- ModerateTIROSINT levothyroxine sodium oral solution recalled for subpotency nationwide
FDA (Drugs) · 2023-03-01
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