The Recall Desk
ModerateFDA (Drugs)·D-1353-2016·Announced 2016-07-20

Gastrodia Capsules Recalled for Unapproved Drug Claims

Murray International Trading Co. is recalling Gastrodia Capsules because they are marketed as dietary supplements but contain drug claims, making them unapproved drugs.

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 hazard is regulatory (unapproved drug status) rather than a specific acute physical injury like a structural defect or high-risk pathogen.

Plain-English summary

Murray International Trading Co., Inc. is recalling Gastrodia Capsules. The product is packaged in 30-count bottles within a box and is manufactured by Lanzhou Manufactory of China in Gansu, China. The remaining labeling contains Chinese characters.

The recall is being conducted because the product is marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Although the product is labeled as a dietary supplement, the labeling bears drug or disease claims. This makes the product an unapproved drug under FDA regulations.

The recall covers all lots of the product. Distribution was nationwide and in Puerto Rico. Consumers should stop using the product and contact the recalling firm for instructions on how to return it or obtain a refund.

The recalled product

Product
GASTRODIA CAPSULES, packaged in 30-count bottles within a box, LANZHOU MANUFACTORY OF CHINA. GANSU CHINA; remaining labeling contains Chinese characters.

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 nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 14 recalled by Murray International Trading Co., Inc. 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 14 products in this recall →