Prescription Levothyroxine Sodium Oral Solution Nationwide Recall Due to Subpotency
IBSA Pharma has recalled TIROSINT levothyroxine sodium oral solution nationwide due to subpotency. Affected lots 220418 and 220560 may contain insufficient active ingredient for proper thyroid hormone replacement therapy.
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: Class II recall for a risk-of-harm product (thyroid replacement medication) with no reported illnesses or injuries. Subpotency represents a real therapeutic risk—patients may not receive adequate thyroid hormone levels, which is critical for patients with hypothyroidism.
Plain-English summary
TIROSINT (levothyroxine sodium) Oral Solution, 200 microgram/mL, is being recalled nationwide by IBSA Pharma Inc. due to subpotency. The recall is voluntary and was initiated on January 30, 2023, in response to findings that certain batches may contain less active ingredient than labeled.
The affected product is a prescription medication distributed nationwide across the United States. Two lots are included in the recall: Lot 220418 (expiring October 2023) and Lot 220560 (expiring November 2023). The product was supplied under NDC 71858-0160-5.
Subpotency means the medication may not provide adequate levothyroxine levels for proper thyroid hormone replacement therapy. Patients taking affected doses may not receive the full therapeutic benefit of their prescribed medication, which could result in inadequate thyroid hormone levels.
Patients with prescriptions for this product should contact their healthcare provider before continuing or stopping use. Do not discontinue levothyroxine therapy without medical guidance. Patients should ask their pharmacist to verify their lot numbers and discuss alternative supplies or options with their healthcare provider if they have affected product.
The recalled product
- Product
- TIROSINT (LEVOTHYROXINE SODIUM)
- Brand
- TIROSINT
- Manufacturer
- IBSA PHARMA INC
- Category
- Drug — Prescription / Endocrine
- Hazard
- subpotency
- therapeutic-failure
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 #: 220418
- Exp. 10/2023
- 220560
- Exp. 11/2023.
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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