FDA recall D-0196-2025

Akron Pharma, Inc. · Class III · drug

Product

Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E, Suite 117, Fairfield, NJ 07034, NDC 71399-8022-02

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-0196-2025