The Recall Desk
HighFDA (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.

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: 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

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 →

Related recalls

Same brand · TIROSINT

Same manufacturer · IBSA PHARMA INC

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Same hazard · subpotency

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