← FDA ENFORCEMENT
D-0193-2025Class III
Akron Pharma, Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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
768 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change ControlReason for recall
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Product description
Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8022-01.
Code / lot info
Lot: KDT0224002A, Exp 09/30/2026
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See all Documentation & Change Control recalls →Data: U.S. FDA. 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. Open the enforcement explorer →