Why it was recalled
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Product description
Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1.
Lot numbers, UPCs & expiration codes
Lot: KDC0124001A Exp 09/30/2026.
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0197-2025
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Dec 12, 2024
- FDA report date
- Jan 22, 2025
- Quantity
- 7198 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akron Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0197-2025, exactly as published.
Show all FDA fields
- City
- Fairfield
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 95944
- Address
- 373 Us Highway 46 Ste 117
- Code information
- Lot: KDC0124001A Exp 09/30/2026.
- Postal code
- 07004-2456
- Report date
- Jan 22, 2025
- Product type
- Drugs
- Recall number
- D-0197-2025
- Classification
- Class III
- Recalling firm
- Akron Pharma, Inc.
- Product quantity
- 7198 bottles
- Reason for recall
- Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1.
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Dec 12, 2024
- Initial firm notification
- Letter
- Center classification date
- Jan 10, 2025