26 FDA recalls mention Oxybenzone. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Oxybenzone.
Reason Mislabeling: The active ingredient list on the label does not match the product's actual ingredients Specifically, the label states Octinoxate 7.5%…
Reason cGMP Deviations
Reason cGMP Deviations
Reason cGMP Deviations
Reason cGMP Deviations
Reason GMP Deviations
Reason Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate.
Reason Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim.
Reason Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Reason Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Reason Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Reason Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Reason Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Reason Labeling: Label mix-up
Reason Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Reason Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Reason GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Reason GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Reason GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Reason GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Reason CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.
Reason Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial contamination.
Reason cGMP Deviations; product does not comply with cGMP requirements
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