Agency classClass IIOur severity:High FDA (Drugs)·D-0332-2023·Announced 2023-03-01

Levothyroxine sodium oral solution recalled nationwide for subpotent dosing

IBSA Pharma is recalling TIROSINT levothyroxine sodium oral solution nationwide due to subpotent drug content. The recall affects lots 220413 and 220964.

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 confirmed subpotency (insufficient active ingredient). No illnesses or injuries reported, but subpotent thyroid replacement medication poses a risk of harm to patients dependent on adequate dosing.

Plain-English summary

IBSA Pharma Inc. is recalling TIROSINT levothyroxine sodium oral solution (100 microgram/mL) nationwide. The recall affects specific lots of the prescription thyroid replacement medication that contain less active ingredient than labeled.

The affected lots are: Lot 220413 (expiration 10/2023) and Lot 220964 (expiration 3/2024). The product was distributed nationwide in the USA. IBSA Pharma initiated this voluntary recall on January 30, 2023, which the FDA formally classified on April 4, 2023.

Levothyroxine sodium is a thyroid replacement medication. Because the recalled lots are subpotent (containing less active ingredient than stated), they may not provide adequate thyroid hormone replacement in patients who depend on this medication.

This recall was terminated on October 31, 2023.

The recalled product

Product: TIROSINT (LEVOTHYROXINE SODIUM)
Brand: TIROSINT
Manufacturer: IBSA PHARMA INC
Category: Drug — Prescription Thyroid Replacement
Hazard: subpotent-drug

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 #: 220413
Exp. 10/2023
220964
Exp. 3/2024.

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
Prescription Levothyroxine Sodium Oral Solution Nationwide Recall Due to Subpotency
FDA (Drugs) · 2023-03-01
High
Levothyroxine sodium oral solution recalled due to subpotency
FDA (Drugs) · 2023-03-01
Moderate
TIROSINT Levothyroxine Oral Solution Recalled for Subpotent Drug Content
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 manufacturer · IBSA PHARMA INC

See all →

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
FDA Recalls TIROSINT Levothyroxine Sodium Oral Solution for Subpotency
FDA (Drugs) · 2023-03-01

Same hazard · subpotent drug