The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1078-2018·Announced 2018-08-22

alba BOTANICA Sunscreen Recalled for Microbial Contamination

The Hain Celestial Group is recalling alba BOTANICA Sensitive Sheer Shield Sunscreen SPF 50+ due to microbial contamination. Consumers should stop using the product.

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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving contamination hazards that may cause adverse health consequences.

Plain-English summary

The Hain Celestial Group, Inc. is recalling 1,098 tubes of alba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free SPF 50+ (85 g / 3 oz). The recall is due to microbial contamination of the non-sterile product. The affected product is identified by Lot code 8041 and UPC 7 24742 00438 5.

The product was distributed to one distributor in California, who may have distributed it further within the United States. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have this product should stop using it and contact the manufacturer for instructions on return or disposal.

The recalled product

Product
alba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+ , 85 g 3 oz tube. Manufactured by: The Haine Celestial Group, Inc. Lake Success, NY, UPC 7 24742 00438 5
Affected units
1,098

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 code 8041

Distribution

Distributed in 1 state:

Same manufacturer · The Hain Celestial Group, Inc. - Worldwide HQ

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