Recall
FDAHealthDecember 12, 2024

Akron Pharma, Inc. — 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

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
December 12, 2024

Nationwide in the US

What's affected?

Product
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.
Lot code
KDC0124002B

Additional details

Lot: KDC0124002B Exp 09/30/2026

What should I do?

Recommended action

Class III recall. Voluntary: Firm initiated Quantity affected: 456 bottles.

View original FDA notice →

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