FDA Drugs recall ·
Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma… recall
- Recall number
- D-0197-2025
- Date
- (initiated December 12, 2024)
- Company / brand
- Akron Pharma, Inc.
373 Us Highway 46 Ste 117, Fairfield, NJ, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 7198 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: KDC0124001A Exp 09/30/2026.
Distribution
Nationwide in the US
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0197-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.