Mayne Pharma Recalls Liothyronine Sodium Tablets Due to Dissolution Failure
Mayne Pharma recalls 11,364 bottles of Liothyronine Sodium Tablets 25 mcg distributed by Perrigo due to failed dissolution specifications.
Use caution until it’s fixed
Failed Dissolution Specifications.
Contact the company
What happened, in plain English
Mayne Pharma Inc is recalling Liothyronine Sodium Tablets, USP 25 mcg in 100-count bottles because they failed dissolution specifications. This means the medication may not release properly in the body, potentially affecting its effectiveness. The product was distributed nationwide by Perrigo. Read more at govinfonow.com/recall/41103-mayne-pharma-recalls-liothyronine-sodium-tablets-due-to-dissolution-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/41103-mayne-pharma-recalls-liothyronine-sodium-tablets-due-to-dissolution-failure · Updated October 11, 2026 · FDA enforcement record: FDA #D-0098-2018
Cite this page
“Mayne Pharma Recalls Liothyronine Sodium Tablets Due to Dissolution Failure.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41103-mayne-pharma-recalls-liothyronine-sodium-tablets-due-to-dissolution-failure. Based on FDA recall #D-0098-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0098-2018%22&limit=1).
Why it’s dangerous
The tablets failed to meet dissolution specifications, which is a quality control test ensuring the drug breaks down correctly. If the tablet does not dissolve as intended, the body may not absorb the full dose, leading to subtherapeutic levels of the hormone.
Who’s affected
Patients who have been prescribed Liothyronine Sodium Tablets 25 mcg and purchased them from retailers across the United States. Individuals relying on this specific dosage for thyroid treatment are most at risk of receiving ineffective medication.
How to tell if you have this one
Check for Liothyronine Sodium Tablets, USP 25 mcg in 100-count bottles. Look for NDC 0574-0222-01 and Lot #16F649 with an expiration date of May 2018. The bottle was distributed by Perrigo.
- Brand
Mayne Pharma- Category
Drug
What to do — step by step
Check your medication
Verify if you have Liothyronine Sodium Tablets, USP 25 mcg, NDC 0574-0222-01, Lot #16F649.
Contact your pharmacist
Speak with your healthcare provider or pharmacist to discuss replacing the medication if you possess the recalled lot.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Who distributed these recalled tablets?
The product was distributed by Perrigo, located in Minneapolis, MN.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0098-2018 (November 9, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0098-2018 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.