FDA Drugs recall ·

Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle… recall

Recall number
D-0196-2025
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
1232 bottles
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

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

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 #s: KDT0224001B, Exp 08/31/2026; KDT0224002B, 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-0196-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.