The Recall Desk
HighFDA (Drugs)·D-0334-2023·Announced 2023-03-01

Levothyroxine oral solution TIROSINT recalled nationwide for subpotency

IBSA Pharma voluntarily recalled TIROSINT levothyroxine sodium oral solution nationwide due to subpotency concerns. Affected lots are 220416 (Exp. 10/2023) and 221053 (Exp. 4/2024).

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 recall for a subpotent medication poses a risk to patient health by potentially providing inadequate thyroid hormone replacement. While no illnesses have been reported and the recall is voluntary, subpotency of thyroid medication is a significant health risk where injury has not yet been documented.

Plain-English summary

IBSA Pharma Inc. has voluntarily recalled TIROSINT levothyroxine sodium oral solution (175 microgram/mL) distributed nationwide in the United States. The product is supplied in 6-pouch packs containing 5 ampules each (NDC 71858-0155-5).

The recall was initiated because certain batches of TIROSINT oral solution were found to be subpotent—containing less active ingredient than labeled. Patients taking the recalled product may not receive the full prescribed dose of levothyroxine sodium, a thyroid hormone replacement medication critical for treating hypothyroidism.

The affected lots are: Lot 220416 with expiration date October 2023 and Lot 221053 with expiration date April 2024. The product was distributed nationwide throughout the USA. The recall was initiated on January 30, 2023 and terminated on October 31, 2023.

If you have received or are taking TIROSINT from one of these lots, contact your healthcare provider before taking any action. Do not discontinue your medication without medical guidance. Return unused product to your pharmacy or contact IBSA Pharma Inc. for additional information regarding the recall.

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 #: 220416
  • Exp. 10/2023
  • 221053
  • Exp. 4/2024.

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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