Low urgency

American Regent, Inc. Issues Voluntary Nationwide Recall of Three Lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) Due to the Presence of Particulate Matter and Lack of Assurance of Sterility

Detected September 3, 2026 · in Food & Beverage Manufacturing (FDA/FSMA/USDA)

American Regent, Inc. Issues Voluntary Nationwide Recall of Three Lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) Due to the Presence of Particulate Matter and Lack of Assurance of Sterility — recall update affecting Food & Beverage Manufacturing (FDA/FSMA/USDA).

Aforeworn detected this change in the Food & Beverage Manufacturing (FDA/FSMA/USDA) space on September 3, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Low urgency. Food & Beverage Manufacturing (FDA/FSMA/USDA) (food manufacturers, beverage makers, co-packers / private label, ingredient suppliers) should confirm how it applies to their specific situation before acting. There is a time constraint attached: as soon as possible. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Food & Beverage Manufacturing (FDA/FSMA/USDA) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.

What changed

American Regent, Inc. Issues Voluntary Nationwide Recall of Three Lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) Due to the Presence of Particulate Matter and Lack of Assurance of Sterility

Who it affects

Food & Beverage Manufacturing (FDA/FSMA/USDA) (food manufacturers, beverage makers, co-packers / private label, ingredient suppliers)

What you must do

Review the new rule now and confirm your operation stays compliant to avoid penalties or loss of standing in Food & Beverage Manufacturing (FDA/FSMA/USDA).

Deadline

as soon as possible

Source: http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-regent-inc-issues-voluntary-nationwide-recall-three-lots-epinephrine-injection-usp-30-mg-30

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