The Recall Desk
ModerateFDA (Drugs)·D-0100-2018·Announced 2017-12-06

Vertra Sunscreen Recalled for Manufacturing Quality Deviations

EAI-JR286 Inc. is recalling 5,355 tubes of Vertra Elemental Resistance Sunscreen due to manufacturing deviations that may impact product quality.

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, but the source text explicitly states no illnesses or injuries are reported and the hazard is related to manufacturing quality (viscosity) rather than a high-risk pathogen or structural defect, fitting the criteria for a moderate, precautionary recall.

Plain-English summary

EAI-JR286 Inc. is recalling 5,355 tubes of Vertra Elemental Resistance Sun Protection Cream, SPF 50+. The product is distributed nationwide in the USA and Puerto Rico. The recall involves Lot # 609124 with an expiration date of 03/18.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the products were manufactured in a manner that may impact product quality, including failed viscosity tests. The source text does not report any illnesses or injuries associated with this recall.

Consumers who have this product should stop using it and contact the distributor for further instructions or a refund.

The recalled product

Product
Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide 9.9%) Sun Protection Cream, SPF 50+, Net. Wt. 2.8 oz (80 g) tube in a carton, Distributed by Vertra/EAI-JR286, 20100 S Vermont Ave, Torrance, CA 90502, Made In Australia, UPC
Manufacturer
EAI-JR286 INC
Affected units
5,355

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)

  • Lot #: 609124

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically: