← FDA ENFORCEMENT
D-0198-2025Class III

Akron Pharma, Inc.

Recalling firm
Akron Pharma, Inc.
Product type
Drug
Status
Ongoing
Report date
2025-01-22
Distribution
Nationwide in the US
Firm state
NJ
Product quantity
456 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

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.

Code / lot info

Lot: KDC0124002B Exp 09/30/2026

Other recalls SPEQ maps to Documentation & Change Control
2026-07-22Class IIDaavlin Distributing Company2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class IIChocolate Bar Holdings LLC
See all Documentation & Change Control recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.