Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 11
Summary
The FDA issued a Class II for Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd by SV Labs Prescott Corporation. Reason: cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing..
Details
Source
Drug Recall
External ID
D-0022-2026
Action Date
2025-10-22
Status
Ongoing
Category
drug
Product Description
Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 112, Eden Prairie, Minnesota 55344
Lot/Code Info: Lot#: 25196, Exp 2/16/2026
Quantity Affected: 11,386 tubes
Reason for Recall
cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-25
Company
Prescott, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 107 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SV Labs Prescott Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SV Labs Prescott Corporation have FDA actions?
This is the only FDA action we have on record for SV Labs Prescott Corporation in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0022-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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