Yes — there is an active recall. 7 ongoing FDA recalls mention Oxybenzone (26 total). Check the affected lots below.
Most common reason: cGMP deviation (11 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Oxybenzone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Mislabeling: The active ingredient list on the label does not match the product's actual ingredients Specifically, the label states Octinoxate 7.5% and Oxybenzone 3%, while the product therein is made with Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%, and Avobenzone 3%.
cGMP Deviations
GMP Deviations
Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate.
Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim.
Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Labeling: Label mix-up
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.
Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial contamination.
cGMP Deviations; product does not comply with cGMP requirements
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