← FDA ENFORCEMENT
D-0199-2025Class III

Akron Pharma, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

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
324 bottles
Initiated by
Voluntary: Firm initiated
Reason for recall

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

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.

Code / lot info

Lot: KDC0224001B Exp 09/30/2026

Data: U.S. FDA. 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. Open the enforcement explorer →