Prescription drug TIROSINT levothyroxine recalled for subpotent formulation
IBSA Pharma has recalled two lots of TIROSINT levothyroxine sodium oral solution nationwide because they contain less active ingredient than labeled. The affected lots are 220409 (expiring 10/2023) and 220956 (expiring 03/2024).
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: This recall is classified as FDA Class II. Although the subpotent drug poses a risk of inadequate thyroid hormone replacement, the source text contains no reports of illnesses or injuries. The recall fits the rubric criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
IBSA Pharma Inc. has voluntarily recalled two specific lots of TIROSINT (levothyroxine sodium) oral solution due to subpotency—the product contains less active ingredient than labeled. The affected lots are 220409 (expiring October 2023) and 220956 (expiring March 2024). Both lots were distributed nationwide across the United States.
Levothyroxine sodium is a prescription thyroid hormone replacement used to treat hypothyroidism. Subpotent medication means patients may receive less of the drug than prescribed, potentially resulting in inadequate thyroid hormone replacement and related health effects.
Patients currently taking TIROSINT from the affected lots should contact their healthcare provider or pharmacist immediately. Do not stop taking the medication without medical advice. Consumers with bottles from the recalled lots should return them to their pharmacy or contact IBSA Pharma for further 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
- Category
- Drug — Thyroid Replacement
- Hazard
- subpotency
- under-dosing
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 #: 220409
- Exp. 10/2023
- 220956
- 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
- 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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