The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0071-2019·Announced 2018-10-24

CeraVe Healing Lip Balm Recalled for Staphylococcus Aureus Contamination

Product Quest Manufacturing LLC is recalling CeraVe Healing Lip Balm/SPF 30 due to failed microbiological testing for Staphylococcus aureus.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a high-risk pathogen (Staphylococcus aureus) in a product applied to the face, meeting the criteria for a Severe rating.

Plain-English summary

Product Quest Manufacturing LLC is recalling 25,596 sticks of CeraVe Healing Lip Balm/SPF 30. The recall was initiated because the product failed microbiological testing for Staphylococcus aureus. The affected product is a 0.15 oz. (4.25 g) stick manufactured by Product Quest Manufacturing LLC for CeraVe LLC. The specific lot number is PSP85W/172792H, and the product carries the UPC 3 01872 49201 7.

The recall covers products distributed nationwide in the USA. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.

Consumers who have this specific lot of CeraVe Healing Lip Balm/SPF 30 should stop using it and contact the recalling firm or retailer for instructions on how to return the product or obtain a refund.

The recalled product

Product
CeraVe Healing Lip Balm/SPF 30 (avobenzone 3%, dimethicone 1%, homosalate 10%, octisalate 5%, octocrylene 10%, Net Wt. 0.15 oz. (4.25 g) stick, CeraVe LLC., New York, NY 10001, UPC 3 01872 49201 7.
Manufacturer
Product Quest Manufacturing LLC
Category
Drug — Topical OTC
Hazard
Affected units
25,596

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: PSP85W/172792H

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 54 recalled by Product Quest Manufacturing LLC 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 54 products in this recall →

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