Class II · Moderate risk
Karina Daily Moisturizer SPF 25
CGMP Deviations
Is Octinoxate recalled?
Yes — there is an active recall. 6 ongoing FDA recalls mention Octinoxate (24 total). Check the affected lots below.
Most common reason: cGMP deviation (12 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Octinoxate. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Octinoxate recalls on record
none so far in 2026; 24 on record, newest first
Class II · Moderate risk
Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30
CGMP Deviations
Class II · Moderate risk
Sea Enzyme Ultra Umbrella Sunscreen SPF 30
CGMP Deviations
Class II · Moderate risk
(Malin+Goetz) spf 30 face moisturizer
GMP Deviations
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
Peppermint Lip Moisturizer
Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.
Class II · Moderate risk
LA FRESH travel lite Sunnyside Lotion Wipe silky
Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling of the product and comments about the product found on e-commerce websites.
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
Naturmetic SPF 50 Sunscreen
GMP Deviations
Class II · Moderate risk
Solar Defense Sheer Sunscreen Broad Spectrum SPF50
GMP Deviations
Class II · Moderate risk
Dry to Normal Skin Starter Kit
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Class II · Moderate risk
Day Cream SPF15 Cr¿me de jour FPS 15
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Class II · Moderate risk
Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class II · Moderate risk
Shiseido Future Solution LX Luxurious Eye & Lip Collection contains SPF 50+
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class II · Moderate risk
Shiseido Future Solution LX Discovery Set contains SPF 50+
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class II · Moderate risk
Shiseido Future Solution LX Universal Defense SPF 50+
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
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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