RecallRadar

FDA Drug recall D-0333-2023

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 125 microgram/mL

On 2023-03-01 the FDA classified a Class II recall of TIROSINT - SOL (levothyroxine sodium) Oral Solution, 125 microgram/mL by Ibsa Pharma, citing subpotent Drug.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0333-2023
ClassificationClass II
Statusterminated
Initiated2023-01-30
Published2023-03-01
Last updated2026-09-13 11:52 UTC
CompanyIbsa Pharma
DistributionUS

Product

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 Pharma Inc., Parsippany, NJ 07054; NDC 71858-0140-5

Reason

Subpotent Drug

Identifiers

ndc71858-0105-6
ndc71858-0105-4
ndc71858-0105-5
ndc71858-0105-1
ndc71858-0105-2
ndc71858-0110-6
ndc71858-0110-4
ndc71858-0110-5
ndc71858-0110-1
ndc71858-0110-2
ndc71858-0112-6
ndc71858-0112-4
ndc71858-0112-5
ndc71858-0112-1
ndc71858-0112-2
ndc71858-0113-6
ndc71858-0113-4
ndc71858-0113-5
ndc71858-0113-1
ndc71858-0113-2
ndc71858-0115-6
ndc71858-0115-4
ndc71858-0115-5
ndc71858-0115-1
ndc71858-0115-2
ndc71858-0117-6
ndc71858-0117-4
ndc71858-0117-5
ndc71858-0117-1
ndc71858-0117-2
ndc71858-0120-6
ndc71858-0120-4
ndc71858-0120-5
ndc71858-0120-1
ndc71858-0120-2
ndc71858-0125-6
ndc71858-0125-4
ndc71858-0125-5
ndc71858-0125-1
ndc71858-0125-2
ndc71858-0130-6
ndc71858-0130-4
ndc71858-0130-5
ndc71858-0130-1
ndc71858-0130-2
ndc71858-0135-6
ndc71858-0135-4
ndc71858-0135-5
ndc71858-0135-1
ndc71858-0135-2
ndc71858-0140-6
ndc71858-0140-4
ndc71858-0140-5
ndc71858-0140-1
ndc71858-0140-2
ndc71858-0145-6
ndc71858-0145-4
ndc71858-0145-5
ndc71858-0145-1
ndc71858-0145-2
ndc71858-0150-6
ndc71858-0150-4
ndc71858-0150-5
ndc71858-0150-1
ndc71858-0150-2
ndc71858-0155-6
ndc71858-0155-4
ndc71858-0155-5
ndc71858-0155-1
ndc71858-0155-2
ndc71858-0160-6
ndc71858-0160-4
ndc71858-0160-5
ndc71858-0160-1
ndc71858-0160-2
code_infoLot #: 220855, Exp. 2/2024.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0333-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.