Determination That PHENAPHEN WITH CODEINE NO. 3 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 30 Milligrams, and PHENAPHEN WITH CODEINE NO. 4 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
FDA confirms that PHENAPHEN WITH CODEINE NO. 3 and NO. 4 are not withdrawn for safety or effectiveness, allowing continued sale.
Aforeworn detected this change in the Pharmaceutical Manufacturing (FDA/DEA) space on September 3, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Medium urgency. Branded drug makers, generic/ANDA manufacturers, API & contract manufacturers, compounding outsourcing (503B). should confirm how it applies to their specific situation before acting. There is a time constraint attached: N/A. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Pharmaceutical Manufacturing (FDA/DEA) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
The determination allows continued sale of specific codeine-containing products without safety or effectiveness concerns.
Who it affects
Branded drug makers, generic/ANDA manufacturers, API & contract manufacturers, compounding outsourcing (503B).
What you must do
Continue production and distribution of PHENAPHEN WITH CODEINE NO. 3 and NO. 4 as they remain on the market.
Deadline
N/A
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