Agency classClass IIOur severity:High FDA (Drugs)·D-0336-2023·Announced 2023-03-01

Levothyroxine Oral Solution TIROSINT Recalled Due to Subpotency

IBSA PHARMA is recalling TIROSINT (levothyroxine sodium) oral solution due to subpotency in specific batches. The affected product may contain less active ingredient than labeled.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 is a Class II recall for a prescription thyroid medication with subpotency—a risk-of-harm condition affecting medication efficacy. Although no illnesses have been reported, patients on thyroid hormone replacement therapy face risk of inadequate treatment.

Plain-English summary

IBSA Pharma Inc. is recalling TIROSINT (levothyroxine sodium) oral solution in response to a subpotency issue identified in certain batches. The affected product is a prescription thyroid hormone replacement medication supplied as an oral solution at 37.5 micrograms per milliliter.

The recall affects specifically two lots: Lot #220552 (expiration 11/2023) and Lot #221055 (expiration 04/2024). These batches contain less active ingredient than the labeled amount, meaning patients may receive a subtherapeutic dose.

The product was distributed nationwide throughout the United States. IBSA Pharma initiated this voluntary recall on January 30, 2023, and the FDA classified it as a Class II recall on April 4, 2023. The recall was terminated on October 31, 2023.

Patients should not stop taking their thyroid medication without consulting their healthcare provider. Those with prescriptions for affected lots should contact their pharmacy or healthcare provider for guidance on obtaining a replacement product with the correct potency.

The recalled product

Product: TIROSINT (LEVOTHYROXINE SODIUM)
Brand: TIROSINT
Manufacturer: IBSA PHARMA INC
Category: Drug
Hazard: subpotency

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 #: 220552
Exp. 11/2023
221055
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 →

Same brand · TIROSINT

High
Thyroid Medication TIROSINT Levothyroxine Sodium Nationwide Recall for Subpotency
FDA (Drugs) · 2023-03-01
High
FDA Recalls TIROSINT Levothyroxine Sodium Lot 220853 for Subpotency
FDA (Drugs) · 2023-03-01
High
Prescription Levothyroxine Sodium Oral Solution Nationwide Recall Due to Subpotency
FDA (Drugs) · 2023-03-01
Moderate
TIROSINT Levothyroxine Oral Solution Recalled for Subpotency
FDA (Drugs) · 2023-03-01
High
Levothyroxine sodium oral solution recalled due to subpotency
FDA (Drugs) · 2023-03-01

Same manufacturer · IBSA PHARMA INC

See all →

Moderate
TIROSINT levothyroxine sodium oral solution recalled for subpotency nationwide
FDA (Drugs) · 2023-03-01
High
Levothyroxine oral solution TIROSINT recalled nationwide for subpotency
FDA (Drugs) · 2023-03-01
High
FDA Recalls TIROSINT Levothyroxine Sodium Oral Solution for Subpotency
FDA (Drugs) · 2023-03-01

Same hazard · subpotency