The Recall Desk
ModerateFDA (Drugs)·D-0013-2019·Announced 2018-10-17

Syntec Pharma Recalls Thyroid Powder Due to Inconsistent Active Ingredient Levels

Syntec Pharma Corp is recalling 5 KG bags of Thyroid Powder USP because the active ingredients levothyroxine and liothyronine have inconsistent levels.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is a CGMP deviation regarding ingredient consistency rather than a high-risk pathogen or structural defect.

Plain-English summary

Syntec Pharma Corp is recalling 2 drums of 5 KG bags of Thyroid Powder USP, Full Strength. This product is an active pharmaceutical ingredient intended for Rx Compounding only. The powder contains levothyroxine and liothyronine.

The recall was initiated after a notice was received from the supplier, Sichuan Friendly Pharmaceutical Co., Ltd., indicating that the Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. This constitutes a Current Good Manufacturing Practice (CGMP) deviation.

The affected product was distributed only in Alabama and Texas. All lots of the product are included in this recall. Consumers and compounding pharmacies should stop using the product and contact the recalling firm for instructions.

The recalled product

Product
THYROID POWDER USP, Full Strength (Levothyroxine labeled range of 103-125mcg/grain; Liothyroine (correct spelling Liothyronine): labeled range of 24.3-29.7mcg/grain) active pharmaceutical ingredient; 5 KG bag, Rx Compounding only, Manu By: Sichuan Friendly Pharmaceutical Co., Ltd
Manufacturer
Syntec Pharma Corp
Category
Drug — Pharmaceutical Ingredient
Hazard
Affected units
2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 recalled by Syntec Pharma Corp under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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