Xylocaine recall — FDA D-0729-2026
Presence of Particulate Matter: Hair was found in products
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
754 detailed records are currently available in this category.
Presence of Particulate Matter: Hair was found in products
Presence of Particulate Matter: Hair was found in product
Subpotent Drug
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be…
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12…
Lack of Assurance of Sterility
Lack of Assurance of Sterility
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Failed Impurities/Degradation Specifications
cGMP deviations
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
Failed Impurities/Degradation Specifications
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
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