Agency classClass IIOur severity:High FDA (Drugs)·D-0340-2023·Announced 2023-03-01

FDA Recalls TIROSINT Levothyroxine Sodium Lot 220853 for Subpotency

IBSA Pharma Inc. recalled TIROSINT levothyroxine sodium lot 220853 nationwide due to subpotency. The oral solution may contain less active ingredient than labeled, potentially affecting thyroid hormone replacement therapy.

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 of subpotent levothyroxine, a risk-of-harm product where patients may not receive adequate thyroid hormone replacement. No illnesses or injuries are reported. Per rubric: risk-of-harm products where injury has not yet been reported score at most 3.

Plain-English summary

IBSA Pharma Inc. initiated a recall of TIROSINT (levothyroxine sodium) Oral Solution, 75 microgram/mL, lot number 220853 with an expiration date of February 2024. The product was distributed nationwide in the United States.

The recall was initiated because the medication was found to be subpotent, meaning it contains less of the active ingredient than the labeled amount. This Class II recall was voluntary and initiated by the firm.

Patients who have used this medication should consult their healthcare provider. Healthcare providers and pharmacies should stop dispensing this lot and help patients obtain replacement medication.

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 #: 220853
Exp. 02/2024.

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 sodium oral solution recalled for subpotency nationwide
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
High
Levothyroxine sodium oral solution recalled nationwide for subpotent dosing
FDA (Drugs) · 2023-03-01
High
Thyroid Drug TIROSINT Recalled Due to Subpotent Formulation
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