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Class III · Lower riskActive recall

Diphenhydramine HCl 50 mg

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot: KDC0224001B Exp 09/30/2026
Where it was soldNationwide in the US
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forAkron Pharma, Inc. 373 Route US 46, Building E, Suite 117, Fairfield, NJ 07004
NDC71399-8026-02
Show the full FDA record
Full product labelDiphenhydramine 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.
Recalling firmAkron Pharma, Inc.
DistributionNationwide in the US
Quantity324 bottles
Recall initiated2024-12-12
Report date2025-01-22
Recall completed—
Recall numberD-0199-2025
ClassificationClass III
FDA statusOngoing
Origin on fileFairfield NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.