GenoGenix BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all recall — FDA D-0086-2026
Lack of Assurance of Sterility
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.
Lack of Assurance of Sterility
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
CGMP Deviations: Market complaints received for gritty texture (grainy)
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Failed Impurities/Degradation Specifications:
Failed Impurities/Degradation Specifications:
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Failed Impurities/Degradation Specifications:
Failed Impurities/Degradation Specifications:
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Failed Impurities/Degradation Specifications:
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No…
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No…
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No…
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No…
Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in…
cGMP deviations: Temperature excursion during transportation.
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