The Recall Desk
HighFDA (Drugs)·D-0337-2023·Announced 2023-03-01

TIROSINT Levothyroxine Sodium Oral Solution Recalled for Subpotency

TIROSINT (levothyroxine sodium) oral solution has been recalled nationwide by IBSA Pharma Inc. due to subpotency, with the affected medication containing 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: FDA Class II classification for a product that may cause adverse health consequences. Subpotency means the medication contains less active ingredient than labeled. No reported illnesses or injuries to date, but the potency deficit poses a risk to therapeutic efficacy.

Plain-English summary

TIROSINT SOL (levothyroxine sodium) oral solution 44 microgram/mL has been recalled nationwide due to subpotency. The affected lots are lot 220553 (expiration 11/2023) and lot 221056 (expiration 04/2024). This is a Class II recall, initiated by IBSA Pharma Inc. on January 30, 2023.

Subpotency means the recalled medication contains less of the active ingredient than labeled. Patients currently using levothyroxine from the affected lots should contact their healthcare provider or pharmacist immediately for guidance on their medication.

The recall was terminated on October 31, 2023. The product was distributed nationwide in the USA by IBSA Pharma Inc., which manufactures the medication in Switzerland. For additional information, patients can contact their healthcare provider or the FDA.

The recalled product

Product
TIROSINT (LEVOTHYROXINE SODIUM)
Brand
TIROSINT
Manufacturer
IBSA PHARMA INC
Category
Drug — Thyroid Hormone
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 #: 220553
  • Exp. 11/2023
  • 221056
  • 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

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Same hazard · subpotency

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