FDA recall D-0197-2025

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.

Reason for recall

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

Distribution

Nationwide in the US

Key facts

Status

Ongoing

Initiation date

2024-12-12

Report date

2025-01-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fairfield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0197-2025