Drug company (FDA labeler)

IBSA Pharma Inc.

NDC labeler code: 71858

What is a labeler?

The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.

Official FDA data only

Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.

Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.

At a glance

3Prescription medicines

36Products (NDC)

5FDA applications

16Recalls

Prescription medicines

LevothyroxineTirosint, Tirosint Sol, Synthroid · 30 products
SildenafilViagra, Vybrique, Revatio · 4 products
Diclofenac epolamineLicart, Flector, Diclox Patch 30ct · 2 products

FDA applications for these products

NDA: New Drug Application: how a new (usually brand-name) medicine is approved.

Approved	Application	Medicine	Sponsor
December 16, 2025	NDA210858	Sildenafil VYBRIQUE	Ibsa
December 19, 2018	NDA206976	Diclofenac epolamine LICART	Ibsa Inst Bio
December 15, 2016	NDA206977	Levothyroxine TIROSINT-SOL	Ibsa
January 31, 2007	NDA021234	Diclofenac epolamine FLECTOR	Ibsa
October 13, 2006	NDA021924	Levothyroxine TIROSINT	Ibsa

The sponsor is the company that holds the FDA application; it can differ from the labeler.

Recall timeline

2023

January 30, 2023 · Class II · Terminated · D-0335-2023 · Levothyroxine

Subpotent Drug

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 25 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA P
January 30, 2023 · Class II · Terminated · D-0341-2023 · Levothyroxine

Subpotent Drug

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 88 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA P
January 30, 2023 · Class II · Terminated · D-0345-2023 · Levothyroxine

Subpotent Drug

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 200 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA
January 30, 2023 · Class II · Terminated · D-0336-2023 · Levothyroxine

Subpotent Drug

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 37.5 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA
January 30, 2023 · Class II · Terminated · D-0331-2023 · Levothyroxine

Subpotent Drug

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 13 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA P
January 30, 2023 · Class II · Terminated · D-0344-2023 · Levothyroxine

Subpotent Drug

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 150 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA
January 30, 2023 · Class II · Terminated · D-0340-2023 · Levothyroxine

Subpotent Drug

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 75 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA P
January 30, 2023 · Class II · Terminated · D-0337-2023 · Levothyroxine

Subpotent Drug

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 44 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA P
January 30, 2023 · Class II · Terminated · D-0338-2023 · Levothyroxine

Subpotent Drug

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 50 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA P
January 30, 2023 · Class II · Terminated · D-0334-2023 · Levothyroxine

Subpotent Drug

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 175 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA

Show the 6 older recalls

2023

January 30, 2023 · Class II · Terminated · D-0332-2023 · Levothyroxine

Subpotent Drug

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 100 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA
January 30, 2023 · Class II · Terminated · D-0343-2023 · Levothyroxine

Subpotent Drug

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 137 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA
January 30, 2023 · Class II · Terminated · D-0339-2023 · Levothyroxine

Subpotent Drug

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 62.5 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA
January 30, 2023 · Class II · Terminated · D-0342-2023 · Levothyroxine

Subpotent Drug

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 112 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA
January 30, 2023 · Class II · Terminated · D-0333-2023 · Levothyroxine

Subpotent Drug

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 125 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA

2021

March 15, 2021 · Class II · Terminated · D-0495-2021 · Levothyroxine

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TIROSINT(levothyroxine sodium) capsules 175MCG 3 blisters X10 capsules; NDC/UPC 71858-0055-4; RX; CAPSULES

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Next steps

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Sources

NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

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