Levothyroxine sodium oral solution recalled due to subpotency
IBSA Pharma Inc. has recalled TIROSINT levothyroxine sodium oral solution nationwide due to subpotency. Some doses may contain less active ingredient than labeled. Patients should contact their healthcare provider.
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 no reported illnesses or injuries. Subpotency is a risk-of-harm condition where patients may receive inadequate thyroid hormone replacement therapy, but the hazard is theoretical rather than manifested.
Plain-English summary
IBSA Pharma Inc. has recalled TIROSINT (levothyroxine sodium) oral solution nationwide due to subpotency. The product, labeled at 62.5 microgram/mL, may contain less active ingredient than stated, which could result in inadequate thyroid hormone replacement.
The recall affects TIROSINT oral solution with lot numbers 220556 (expiring November 2023) and 221058 (expiring April 2024). The product is a prescription medication distributed nationwide.
Patients taking TIROSINT from these lots should contact their healthcare provider to determine if they have been affected by this recall and to discuss their medication. Their provider can advise on appropriate next steps.
This is a voluntary recall initiated by the manufacturer on January 30, 2023, and classified as FDA Class II. The recall was terminated on October 31, 2023.
The recalled product
- Product
- TIROSINT (LEVOTHYROXINE SODIUM)
- Brand
- TIROSINT
- Manufacturer
- IBSA PHARMA INC
- Hazard
- subpotency
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 #: 220556
- Exp. 11/2023
- 221058
- 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
- ModerateTIROSINT Levothyroxine Oral Solution Recalled for Subpotent Drug Content
FDA (Drugs) · 2023-03-01
- HighPrescription drug TIROSINT levothyroxine recalled for subpotent formulation
FDA (Drugs) · 2023-03-01
- 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 sodium oral solution recalled for subpotency nationwide
FDA (Drugs) · 2023-03-01
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