Diphenhydramine HCl 25 mg recall — Class III (D-0197-2025) · pharmaranks
Class IIIOngoing
Diphenhydramine HCl 25 mg recall
FDA recall D-0197-2025 · initiated Dec 12, 2024
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Details
Product
Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1.
Recalling company
Akron Pharma, Inc.
Classification
Class III
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
Nationwide in the US
Initiated
Dec 12, 2024
FDA report date
Jan 22, 2025
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.