Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0014-2019·Announced 2018-10-17

Syntec Pharma Recalls Thyroid Powder Due to Inconsistent Active Ingredient Levels

Syntec Pharma Corp is recalling 486 kg of Thyroid Powder USP because the active ingredients levothyroxine and liothyronine have inconsistent levels.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.

Plain-English summary

Syntec Pharma Corp is recalling 486 kg of Thyroid Powder USP, a 25 kg bag active pharmaceutical ingredient intended for prescription compounding only. The product was manufactured by Sichuan Friendly Pharmaceutical Co., Ltd. in China and distributed by Syntec Pharma Corp in Farmingdale, New York.

The recall was initiated after the supplier reported CGMP deviations, specifically that the Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. The labeled range for levothyroxine is 34.2-41.8mcg/grain, and for liothyronine is 8.1-9.9mcg/grain. The recall covers all lots of the product.

The affected product was distributed only to Alabama and Texas. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions.

The recalled product

Product: 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…
Manufacturer: Syntec Pharma Corp
Category: Drug — Pharmaceutical Ingredient
Hazard: inconsistent-ingredients
cgmp-deviation

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 →

Same manufacturer · Syntec Pharma Corp

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Moderate
Syntec Pharma Recalls Thyroid Powder Due to Inconsistent Active Ingredient Levels
FDA (Drugs) · 2018-10-17

Same hazard · inconsistent ingredients