Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma...
FDA Recall #D-0198-2025 — Class III — December 12, 2024
Product Description
Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite 117, Fairfield, NJ 07004, NDC 71399-8028-2.
Reason for Recall
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Recalling Firm
Akron Pharma, Inc. — Fairfield, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
456 bottles
Distribution
Nationwide in the US
Code Information
Lot: KDC0124002B Exp 09/30/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated