CLASS II Drug recall · Reported 17 Oct 2018 · FDA Enforcement Report
Thyroid Powder USP (Levothyroxine labeled range of 2-41.8mcg/grain recalled
Syntec Pharma is recalling Thyroid Powder USP (Levothyroxine labeled range of 2-41.8mcg/grain, distributed in Texas. The recall was initiated on 22 Aug 2018 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-0014-2019
- FDA event ID
- 81128
- Recalling firm
- Syntec Pharma, Farmingdale, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Aug 2018
- FDA classified
- 11 Oct 2018
- Reported
- 17 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Thyroid Medication
Timeline
| 22 Aug 2018 | Recall initiated by company | |
| 11 Oct 2018 | Classified by FDA | +50 days |
| 17 Oct 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Product as listed by the FDA
THYROID POWDER USP (Levothyroxine labeled range of 34.2-41.8mcg/grain; Liothyroine (correct spelling Liothyronine): labeled range of 8.1-9.9mcg/grain) active pharmaceutical ingredient; 25 KG bag, Rx Compounding only, Manu By: Sichuan Friendly Pharmaceutical Co., Ltd., No. 680 Hongpai Road, Neijiang, sichuan 641000, china; Distributed: Syntec Pharma Corp., 96 Gazza Blvd., Farmingdale NY 11735, CAS No. 50809-32-0
Where it was distributed
Al & TX only
Questions about this recall
Is Thyroid Powder USP (Levothyroxine labeled range of 2-41.8mcg/grain recalled?
Yes. Syntec Pharma recalled Thyroid Powder USP (Levothyroxine labeled range of 2-41.8mcg/grain on 22 Aug 2018. The recall is Class II and its status is Terminated. Recall number D-0014-2019.
Why was it recalled?
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Which lots are affected?
All lots
Where was it sold?
Al & TX only
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 21 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 Syntec Pharma
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Thyroid Powder USP, Full Strength recalled by Syntec Pharma | Syntec Pharma | Manufacturing (CGMP) Deviations | TX |
Other Thyroid recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Thyroid Powder, USP/drum recalled by LGM Pharma | LGM Pharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Thyroid Powder USP, Full Strength recalled by Syntec Pharma | Syntec Pharma | Manufacturing (CGMP) Deviations | TX |
| Drug | CLASS II | Thyroid powder, kg recalled by Alkano Chemicals | Alkano Chemicals | Manufacturing (CGMP) Deviations | MN |
| Drug | CLASS II | Thyroid Powder/drum, US Pharmacopoeia recalled by Sichuan Friendly | Sichuan Friendly Pharmaceutical Co | Manufacturing (CGMP) Deviations | Nationwide |