The Recall Desk
HighFDA (Drugs)·D-0335-2023·Announced 2023-03-01

Prescription Thyroid Medication TIROSINT Recalled for Subpotent Dosages Nationwide

IBSA Pharma is recalling certain lots of TIROSINT (levothyroxine sodium) oral solution nationwide because the product contains less active ingredient than labeled. Patients using affected lots may not receive adequate thyroid hormone replacement.

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: While no illnesses or hospitalizations were reported, a subpotent thyroid medication represents a risk-of-harm situation because patients may not receive adequate hormone replacement therapy needed to manage their condition. This meets the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.

Plain-English summary

IBSA Pharma Inc. is recalling specific lots of TIROSINT (levothyroxine sodium) oral solution, a prescription thyroid medication. The product is supplied as an oral solution at 25 microgram/mL in packages of 6 pouches containing 5 ampules each. The affected lot is Lot #220856 with an expiration date of February 2024.

The recall was initiated because the medication is subpotent—it contains less levothyroxine sodium than the labeled amount. This means patients taking the affected product may not receive the full therapeutic dose needed to properly manage their thyroid condition.

The product was distributed nationwide in the United States. The recall is voluntary and was initiated by the firm on January 30, 2023, with FDA classification as a Class II recall. The recall was terminated on October 31, 2023.

Patients who have been prescribed TIROSINT from the affected lot should contact their healthcare provider or pharmacy to discuss whether their medication is from the recalled lot and to determine if their prescription needs to be replaced. Do not stop taking thyroid medication without consulting a healthcare provider, as abrupt discontinuation can be harmful.

The recalled product

Product
TIROSINT (LEVOTHYROXINE SODIUM)
Brand
TIROSINT
Manufacturer
IBSA PHARMA INC
Category
Drug — Thyroid Replacement Therapy
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 (2)

  • Lot #: 220856
  • Exp. 2/2024.

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 · subpotent drug

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