CLASS II Drug recall · Reported 1 Mar 2023 · FDA Enforcement Report
Tirosint - SOL (levothyroxine sodium) Oral Solution recalled
Ibsa Pharma is recalling Tirosint - SOL (levothyroxine sodium) Oral Solution, 112 microgram/mL; 6 pouches x 5, distributed nationwide in the US. The recall was initiated on 30 Jan 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0342-2023
- FDA event ID
- 91556
- Recalling firm
- Ibsa Pharma, Parsippany, NJ
- Brand
- Tirosint
- Manufacturer
- IBSA Pharma Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jan 2023
- FDA classified
- 4 Apr 2023
- Reported
- 1 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Thyroid Medication
Timeline
| 30 Jan 2023 | Recall initiated by company | |
| 1 Mar 2023 | Published in enforcement report | +30 days |
| 4 Apr 2023 | Classified by FDA | +34 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 112 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 71858-0135-5
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot #: 220414, Exp. 10/2023; 220852, Exp. 02/2024; 220970, Exp. 03/2024.
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
14 other products · FDA event 91556This product is part of a recall event; the main page for the event is Tirosint - SOL (levothyroxine sodium) Oral Solution recalled.
More recalls from Ibsa Pharma
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tirosint - SOL (levothyroxine sodium) Oral Solution recalledTirosint | Ibsa Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Tirosint - SOL (levothyroxine sodium) Oral Solution recalledTirosint | Ibsa Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Tirosint - SOL (levothyroxine sodium) Oral Solution recalledTirosint | Ibsa Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Tirosint - SOL (levothyroxine sodium) Oral Solution recalledTirosint | Ibsa Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Tirosint - SOL (levothyroxine sodium) Oral Solution recalledTirosint | Ibsa Pharma | Potency & Assay | Nationwide |
Other Levothyroxine recalls
All 145| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |