Class II · Moderate risk
(Malin+Goetz) spf 30 face moisturizer
GMP Deviations
Is Octisalate recalled?
Yes — there is an active recall. 27 ongoing FDA recalls mention Octisalate (40 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Octisalate. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Octisalate recalls on record
none so far in 2026; 40 on record, newest first
Class II · Moderate risk
Tropical Lip Moisturizer
Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate.
Class II · Moderate risk
Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm
Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim.
Class II · Moderate risk
EcoLips Sport Lip Balm
Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allowable 3% in the sunscreen formula per FDA sunscreen regulations.
Class II · Moderate risk
Dermatone (avobenzone, homosalate, octisalate, and octocrylene)
Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Class II · Moderate risk
Dermatone (avobenzone, homosalate, octisalate, and octocrylene)
Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Class III · Low risk
festpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN…
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk
Options Rx Anti-Oxidant Oil-Free Sunscreeen
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Class III · Low risk
Advanced Protection Sunscreen spf 30
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Class II · Moderate risk
CeraVe Healing Lip Balm/SPF 30
Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.
Class II · Moderate risk
Coppertone Kids Sunscreen Spray
Labeling: Label mix-up
Class II · Moderate risk
Double Hyaluronic 1000
Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial contamination.
Class II · Moderate risk
Repaskin 30
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Repaskin 30
cGMP Deviations; product does not comply with cGMP requirements
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