Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0333-2023·Announced 2023-03-01

TIROSINT Levothyroxine Oral Solution Recalled for Subpotent Drug Content

IBSA PHARMA INC is recalling TIROSINT oral solution (Lot #220855) nationwide due to insufficient potency of levothyroxine sodium. The defective lot was voluntarily recalled after manufacturer discovery.

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 a Class II recall with no reported illnesses, hospitalizations, or adverse events. The defect—insufficient potency of the active ingredient—is a quality deficiency without demonstrated harm, consistent with voluntary precautionary recalls classified as Moderate.

Plain-English summary

IBSA PHARMA INC is recalling TIROSINT (levothyroxine sodium) Oral Solution, 125 microgram/mL. The affected product is lot #220855 with expiration date February 2024, distributed nationwide in 6-pouch packages containing 5 ampules each.

The recall was initiated due to subpotency—the product contains insufficient levothyroxine sodium. IBSA PHARMA INC voluntarily initiated the recall beginning January 30, 2023. The recall was terminated as of October 31, 2023.

This is a Class II recall. For inquiries regarding this product, customers may contact IBSA PHARMA INC at 8 Campus Drive, Suite 201, Parsippany, NJ 07054.

The recalled product

Product: TIROSINT (LEVOTHYROXINE SODIUM)
Brand: TIROSINT
Manufacturer: IBSA PHARMA INC
Category: Drug
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 #: 220855
Exp. 2/2024.

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
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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
Levothyroxine sodium oral solution recalled nationwide for subpotent dosing
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Thyroid Drug TIROSINT Recalled Due to Subpotent Formulation
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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
Moderate
TIROSINT Levothyroxine Oral Solution Recalled for 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

Same hazard · subpotent drug