The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0342-2023·Announced 2023-03-01

FDA Recalls TIROSINT Levothyroxine Sodium Oral Solution for Subpotency

IBSA Pharma Inc. voluntarily recalled specific lots of TIROSINT (levothyroxine sodium) Oral Solution nationwide due to subpotency. The affected medication contains 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: FDA Class II recall for subpotent drug that presents a risk of inadequate thyroid hormone therapy. No illnesses or injuries were reported in the source.

Plain-English summary

IBSA Pharma Inc. is recalling specific lots of TIROSINT (levothyroxine sodium) Oral Solution, a prescription thyroid hormone replacement medication, distributed nationwide in the United States. The affected product is TIROSINT - SOL (levothyroxine sodium) Oral Solution, 112 microgram/mL, packaged as 6 pouches x 5 ampules. Three specific lots have been identified: Lot #220414 (expiration 10/2023), Lot #220852 (expiration 02/2024), and Lot #220970 (expiration 03/2024).

The recall was initiated because these lots were found to be subpotent—containing less levothyroxine sodium than the labeled amount. Patients receiving subpotent medication may not receive adequate thyroid hormone replacement therapy.

Patients who have received this medication should contact their healthcare provider to verify whether their product may be affected and discuss their treatment options. Healthcare providers and patients can identify affected lots by checking the lot number and expiration date on the package.

Patients should not discontinue their thyroid medication without consulting their healthcare provider. The recall was voluntarily initiated by the manufacturer on January 30, 2023, and terminated on October 31, 2023.

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 (6)

  • Lot #: 220414
  • Exp. 10/2023
  • 220852
  • Exp. 02/2024
  • 220970
  • Exp. 03/2024.

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 →

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