Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0344-2023·Announced 2023-03-01

TIROSINT Levothyroxine Oral Solution Recalled for Subpotency

IBSA Pharma has recalled one lot of TIROSINT (levothyroxine sodium) oral solution nationwide due to subpotency. The product contained 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This recall is scored as Moderate because it is an FDA Class II voluntary recall with no reported illnesses or injuries. The hazard (subpotency) is real but no adverse outcomes have been documented.

Plain-English summary

IBSA Pharma Inc. has initiated a voluntary recall of TIROSINT (levothyroxine sodium) oral solution, 150 microgram/mL. The recalled product is lot #220959 with expiration March 2024, which was distributed nationwide in the USA. The recall was initiated on January 30, 2023, and was terminated on October 31, 2023. The FDA classified this as a Class II recall.

The reason for the recall is subpotency, meaning the product contains less levothyroxine sodium than labeled. Patients currently using this product from the affected lot would receive lower doses of thyroid hormone replacement than prescribed.

The recalled product

Product: TIROSINT (LEVOTHYROXINE SODIUM)
Brand: TIROSINT
Manufacturer: IBSA PHARMA INC
Category: Drug — Thyroid Hormone 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 (2)

Lot #: 220959
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

Moderate
TIROSINT Levothyroxine Oral Solution Recalled for Subpotent Drug Content
FDA (Drugs) · 2023-03-01
Moderate
TIROSINT levothyroxine sodium oral solution recalled for subpotency nationwide
FDA (Drugs) · 2023-03-01
High
Levothyroxine oral solution TIROSINT recalled nationwide for subpotency
FDA (Drugs) · 2023-03-01
High
Prescription Thyroid Medication TIROSINT Recalled for Subpotent Dosages Nationwide
FDA (Drugs) · 2023-03-01
High
Levothyroxine sodium oral solution recalled nationwide for subpotent dosing
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
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
High
FDA Recalls TIROSINT Levothyroxine Sodium Oral Solution for Subpotency
FDA (Drugs) · 2023-03-01
High
Levothyroxine Oral Solution TIROSINT Recalled Due to Subpotency
FDA (Drugs) · 2023-03-01

Same hazard · subpotent drug