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
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.
Part of a larger recall action
This product is one of 15 recalled by IBSA PHARMA INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 15 products in this recall →Related recalls
Same brand · TIROSINT
- HighFDA Recalls TIROSINT Levothyroxine Sodium Lot 220853 for Subpotency
FDA (Drugs) · 2023-03-01
- HighPrescription Levothyroxine Sodium Oral Solution Nationwide Recall Due to Subpotency
FDA (Drugs) · 2023-03-01
- ModerateTIROSINT Levothyroxine Oral Solution Recalled for Subpotency
FDA (Drugs) · 2023-03-01
- HighFDA Recalls TIROSINT Levothyroxine Sodium Oral Solution for Subpotency
FDA (Drugs) · 2023-03-01
- HighLevothyroxine Oral Solution TIROSINT Recalled Due to Subpotency
FDA (Drugs) · 2023-03-01
Same manufacturer · IBSA PHARMA INC
See all →- ModerateTIROSINT levothyroxine sodium oral solution recalled for subpotency nationwide
FDA (Drugs) · 2023-03-01
- HighLevothyroxine oral solution TIROSINT recalled nationwide for subpotency
FDA (Drugs) · 2023-03-01
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