Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0343-2023·Announced 2023-03-01

TIROSINT levothyroxine sodium oral solution recalled for subpotency nationwide

IBSA Pharma Inc. is recalling TIROSINT (levothyroxine sodium) oral solution due to subpotency—some doses contain insufficient active ingredient. Patients should contact their pharmacist or doctor to verify their medication.

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 is an FDA Class II recall initiated voluntarily by the firm. No illnesses or injuries are reported in the source. The subpotency issue is a precautionary quality matter managed proactively, fitting the rubric criterion for voluntary precautionary recalls.

Plain-English summary

IBSA Pharma Inc. is recalling TIROSINT (levothyroxine sodium) oral solution, 137 microgram/mL, in packages of 6 pouches x 5 ampules, distributed nationwide in the United States. The affected product includes Lot #220415 (expiration October 2023) and Lot #221052 (expiration April 2024). The FDA assigned recall number D-0343-2023.

The firm initiated this recall due to subpotency—some doses contain less active ingredient than labeled. Levothyroxine sodium is a prescription medication used to treat hypothyroidism and requires precise dosing for therapeutic effectiveness.

Patients taking TIROSINT from the affected lots should contact their pharmacist or healthcare provider to confirm their medication is not part of this recall and to discuss whether a switch to an alternative levothyroxine product is needed. Do not discontinue thyroid medication without medical guidance. The recall was initiated on January 30, 2023, and was terminated on October 31, 2023.

The recalled product

Product: TIROSINT (LEVOTHYROXINE SODIUM)
Brand: TIROSINT
Manufacturer: IBSA PHARMA INC
Category: Drug — Thyroid Replacement Therapy
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 #: 220415
Exp. 10/2023
221052
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
Thyroid Medication TIROSINT Levothyroxine Sodium Nationwide Recall 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 Oral Solution Recalled for Subpotency
FDA (Drugs) · 2023-03-01
High
Levothyroxine oral solution TIROSINT recalled nationwide for subpotency
FDA (Drugs) · 2023-03-01
Moderate
TIROSINT Levothyroxine Oral Solution Recalled for Subpotent Drug Content
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
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