← FDA ENFORCEMENT
D-0195-2025Class III

Akron Pharma, Inc.

Recalling firm
Akron Pharma, Inc.
Product type
Drug
Status
Ongoing
Report date
2025-01-22
Distribution
Nationwide in the US
Firm state
NJ
Product quantity
14825 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

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

Product description

Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01.

Code / lot info

Lot #s: KDT0124004, KDT0124005, KDT0124006, Exp 08/31/2026

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.