Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles recall — FDA D-1237-2020
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
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.
10,685 detailed records are currently available in this category.
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Microbial contamination of non-sterile products: positive test for yeast and bacteria.
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.
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