FDA Recalls TIROSINT Levothyroxine Sodium Oral Solution for Subpotency
IBSA Pharma Inc. voluntarily recalled specific lots of TIROSINT (levothyroxine sodium) Oral Solution nationwide due to subpotency. The affected medication contains less active ingredient than labeled.
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 for subpotent drug that presents a risk of inadequate thyroid hormone therapy. No illnesses or injuries were reported in the source.
Plain-English summary
IBSA Pharma Inc. is recalling specific lots of TIROSINT (levothyroxine sodium) Oral Solution, a prescription thyroid hormone replacement medication, distributed nationwide in the United States. The affected product is TIROSINT - SOL (levothyroxine sodium) Oral Solution, 112 microgram/mL, packaged as 6 pouches x 5 ampules. Three specific lots have been identified: Lot #220414 (expiration 10/2023), Lot #220852 (expiration 02/2024), and Lot #220970 (expiration 03/2024).
The recall was initiated because these lots were found to be subpotent—containing less levothyroxine sodium than the labeled amount. Patients receiving subpotent medication may not receive adequate thyroid hormone replacement therapy.
Patients who have received this medication should contact their healthcare provider to verify whether their product may be affected and discuss their treatment options. Healthcare providers and patients can identify affected lots by checking the lot number and expiration date on the package.
Patients should not discontinue their thyroid medication without consulting their healthcare provider. The recall was voluntarily initiated by the manufacturer on January 30, 2023, and 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 (6)
- Lot #: 220414
- Exp. 10/2023
- 220852
- Exp. 02/2024
- 220970
- Exp. 03/2024.
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
- HighLevothyroxine sodium oral solution 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
- ModerateTIROSINT levothyroxine sodium oral solution recalled for subpotency nationwide
FDA (Drugs) · 2023-03-01
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