The Recall Desk
LowFDA (Drugs)·D-0553-2018·Announced 2018-02-07

Unapproved Indian God Lotion Spray Bottle Recalled by FDA

A&H Focal Inc. is recalling Indian God Lotion Spray Bottles because the product is an unapproved drug containing diethyl phthalate.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The agency classified this as an FDA Class III recall, which the rubric defines as unlikely to cause adverse health consequences.

Plain-English summary

A&H Focal Inc. is recalling Indian God Lotion Spray Bottles that have labeling in a foreign language. The product was distributed in New York and New Jersey through six retail stores named "Asian Food Markets." All lots are affected by this recall.

The U.S. Food and Drug Administration (FDA) determined that the product contains diethyl phthalate, an inactive ingredient typically found in modified release solid oral dosage forms. Because the product is an unapproved drug for which safety and efficacy have not been established, it is subject to recall.

Consumers who purchased this product should stop using it and contact the recalling firm for further instructions.

The recalled product

Product
Indian God Lotion Spray Bottle, labeling is in foreign language
Manufacturer
A&H Focal Inc.

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 21 recalled by A&H Focal 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 21 products in this recall →