TIROSINT Levothyroxine Oral Solution Recalled for Subpotency
IBSA Pharma has recalled one lot of TIROSINT (levothyroxine sodium) oral solution nationwide due to subpotency. The product contained less active ingredient than labeled.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This recall is scored as Moderate because it is an FDA Class II voluntary recall with no reported illnesses or injuries. The hazard (subpotency) is real but no adverse outcomes have been documented.
Plain-English summary
IBSA Pharma Inc. has initiated a voluntary recall of TIROSINT (levothyroxine sodium) oral solution, 150 microgram/mL. The recalled product is lot #220959 with expiration March 2024, which was distributed nationwide in the USA. The recall was initiated on January 30, 2023, and was terminated on October 31, 2023. The FDA classified this as a Class II recall.
The reason for the recall is subpotency, meaning the product contains less levothyroxine sodium than labeled. Patients currently using this product from the affected lot would receive lower doses of thyroid hormone replacement than prescribed.
The recalled product
- Product
- TIROSINT (LEVOTHYROXINE SODIUM)
- Brand
- TIROSINT
- Manufacturer
- IBSA PHARMA INC
- Hazard
- subpotent-drug
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 (2)
- Lot #: 220959
- Exp. 3/2024.
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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