The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1533-2019·Announced 2019-08-07

Festpak Sunscreen Recalled for Missing Stability Testing

Festpak is recalling 20,000 units of SPF 30 sunscreen lotion because stability testing was not conducted on the product.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

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

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The issue is a documentation and testing deviation rather than a direct safety hazard.

Plain-English summary

Festpak is recalling 20,000 units of festpak clearly fun SPF30 sunscreen lotion. The product is distributed by festpak in Austin, Texas, and was manufactured by NingBo Huize Commodity Co.,Ltd. in China.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, stability testing was not conducted on the manufactured sunscreen and hand sanitizer OTC products. The affected lots are 20181008 (expiring 10/07/2020) and 20181009 (expiring 10/08/2020).

The product was distributed to seven consignees located in China. Consumers should stop using the product and contact the distributor for further instructions.

The recalled product

Product
festpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0% Titanium Dioxide 2.5% Sunscreen Distributed by: festpak - Austin, TX 78732 Made in China
Manufacturer
NingBo Huize Commodity Co.,Ltd.
Category
Drug — Sunscreen
Hazard

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 (4)

  • Lot #: 20181008
  • Exp 10/07/2020
  • 20181009
  • Exp 10/08/2020

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 36 recalled by NingBo Huize Commodity Co.,Ltd. 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 36 products in this recall →

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