← FDA ENFORCEMENT
D-0199-2025Class 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
324 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 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

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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.