Agency classClass IIOur severity:High FDA (Drugs)·D-0339-2023·Announced 2023-03-01

Levothyroxine sodium oral solution recalled due to subpotency

IBSA Pharma Inc. has recalled TIROSINT levothyroxine sodium oral solution nationwide due to subpotency. Some doses may contain less active ingredient than labeled. Patients should contact their healthcare provider.

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 with no reported illnesses or injuries. Subpotency is a risk-of-harm condition where patients may receive inadequate thyroid hormone replacement therapy, but the hazard is theoretical rather than manifested.

Plain-English summary

IBSA Pharma Inc. has recalled TIROSINT (levothyroxine sodium) oral solution nationwide due to subpotency. The product, labeled at 62.5 microgram/mL, may contain less active ingredient than stated, which could result in inadequate thyroid hormone replacement.

The recall affects TIROSINT oral solution with lot numbers 220556 (expiring November 2023) and 221058 (expiring April 2024). The product is a prescription medication distributed nationwide.

Patients taking TIROSINT from these lots should contact their healthcare provider to determine if they have been affected by this recall and to discuss their medication. Their provider can advise on appropriate next steps.

This is a voluntary recall initiated by the manufacturer on January 30, 2023, and classified as FDA Class II. The recall was terminated on October 31, 2023.

The recalled product

Product: TIROSINT (LEVOTHYROXINE SODIUM)
Brand: TIROSINT
Manufacturer: IBSA PHARMA INC
Category: Drug — Thyroid hormone replacement
Hazard: subpotency

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 #: 220556
Exp. 11/2023
221058
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 →

Same brand · TIROSINT

High
FDA Recalls TIROSINT Levothyroxine Sodium Oral Solution for Subpotency
FDA (Drugs) · 2023-03-01
High
FDA Recalls TIROSINT Levothyroxine Sodium Lot 220853 for Subpotency
FDA (Drugs) · 2023-03-01
Moderate
TIROSINT levothyroxine sodium oral solution recalled for subpotency nationwide
FDA (Drugs) · 2023-03-01
High
Thyroid Drug TIROSINT Recalled Due to Subpotent Formulation
FDA (Drugs) · 2023-03-01
High
Levothyroxine Oral Solution TIROSINT Recalled Due to Subpotency
FDA (Drugs) · 2023-03-01

Same manufacturer · IBSA PHARMA INC

See all →

High
Prescription Levothyroxine Sodium Oral Solution Nationwide Recall Due to Subpotency
FDA (Drugs) · 2023-03-01
Moderate
TIROSINT Levothyroxine Oral Solution Recalled for Subpotency
FDA (Drugs) · 2023-03-01
High
Levothyroxine oral solution TIROSINT recalled nationwide for subpotency
FDA (Drugs) · 2023-03-01

Same hazard · subpotency