FDA Drugs recall ·
Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma… recall
- Recall number
- D-0198-2025
- 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
- 456 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
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: KDC0124002B 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-0198-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.