Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma...
FDA Recall #D-0199-2025 — Class III — December 12, 2024
Product Description
Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8026-02.
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
324 bottles
Distribution
Nationwide in the US
Code Information
Lot: KDC0224001B Exp 09/30/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated