CLASS II Drug recall · Reported 6 Dec 2017 · FDA Enforcement Report
Liothyronine Sodium Tablets, USP 25 mcg recalled by Mayne Pharma
Mayne Pharma is recalling Liothyronine Sodium Tablets, USP 25 mcg, distributed nationwide in the US. The recall was initiated on 9 Nov 2017 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-0098-2018
- FDA event ID
- 78544
- Recalling firm
- Mayne Pharma, Greenville, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Nov 2017
- FDA classified
- 29 Nov 2017
- Reported
- 6 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Thyroid Medication
Timeline
| 9 Nov 2017 | Recall initiated by company | |
| 29 Nov 2017 | Classified by FDA | +20 days |
| 6 Dec 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications.
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
Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perrigo Minneapolis, MN 55427, NDC 0574-0222-01
Where it was distributed
Nationwide within USA
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications.
Which lots are affected?
Lot: #:16F649, Exp: May 2018
Where was it sold?
Nationwide within 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.
More recalls from Mayne Pharma
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches recalledClonidine | Mayne Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Lexette (halobetasol propionate) Topical Foam, 0.05% canisters recalled | Mayne Pharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Carbidopa and Levodopa Tablets, USP 25 mg/250mg recalled by Mayne Pharma | Mayne Pharma | Packaging Defects | Nationwide |
| Drug | CLASS III | Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg recalled | Mayne Pharma | Labeling Errors | Nationwide |
| Drug | CLASS III | Fabior (tazarotene) Foam recalled by Mayne PharmaFabior | Mayne Pharma | Potency & Assay | Nationwide |
Other Liothyronine recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Liothyronine Sodium Tablets, USP 5 mcg recalledLiothyronine Sodium | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Liothyronine Sodium Tablets, USP, 25 mcg recalledLiothyronine Sodium | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Liothyronine Sodium Tablets, USP, 5 mcg recalledLiothyronine Sodium | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Liothyronine Sodium Tablets, USP 5 mcg recalledLiothyronine Sodium | SigmaPharm Laboratories | Other | Nationwide |
| Drug | CLASS II | Liothyronine Sodium, Tablet, 25 mcg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |