Thyroid Drug TIROSINT Recalled Due to Subpotent Formulation
IBSA Pharma Inc. recalls TIROSINT (levothyroxine sodium) oral solution nationwide due to subpotent formulation containing 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 classification indicates a serious health hazard. However, no reported illnesses or injuries are documented in the source, and the hazard of inadequate dosing is theoretical. Per the rubric, when no illnesses are reported and the hazard is theoretical, the maximum score is 3.
Plain-English summary
IBSA Pharma Inc. has recalled TIROSINT (levothyroxine sodium) oral solution, a prescription thyroid hormone replacement medication, nationwide in the United States. The affected product is the 88 microgram/mL strength in 6-pouch packages (5 ampules per pouch). Specific affected lots are 220411 (expiration October 2023) and 220854 (expiration February 2024).
The recall was initiated because the product is subpotent, meaning it contains less active ingredient than the labeled strength. Patients using the affected product may not receive the full intended dose of thyroid hormone medication.
Patients taking TIROSINT from the affected lots should contact their healthcare provider immediately. Do not stop taking thyroid medication without medical guidance, as abrupt discontinuation can cause serious health problems. Healthcare providers should verify lot numbers and, if affected, switch patients to an alternative levothyroxine product.
IBSA Pharma Inc. initiated this voluntary recall on January 30, 2023. The recall was classified as FDA Class II and was terminated on October 31, 2023.
The recalled product
- Product
- TIROSINT (LEVOTHYROXINE SODIUM)
- Brand
- TIROSINT
- Manufacturer
- IBSA PHARMA INC
- Category
- Drug — Thyroid Medication
- Hazard
- subpotent-drug
- under-dosage
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 #: 220411
- Exp. 10/2023
- 220854
- Exp. 02/2024.
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
- 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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