Acetaminophen 325 mg tablets recalled for incorrect imprinting
Akron Pharma is recalling 14,825 bottles of Acetaminophen 325 mg tablets due to incorrect tablet imprinting affecting lots KDT0124004, KDT0124005, and KDT0124006 (expiring August 31, 2026). No illnesses have been reported.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall for a labeling defect (incorrect tablet imprinting) with no reported illnesses, injuries, or deaths. Class III recalls are typically scored 1-2; this rates as Moderate due to the functional importance of tablet imprinting for correct medication identification.
Plain-English summary
Akron Pharma, Inc. is recalling Acetaminophen 325 mg tablets in 100-tablet bottles. A total of 14,825 bottles are affected. The product was manufactured in Fairfield, New Jersey (NDC 71399-8014-01).
The recall is being issued due to a labeling defect: the tablets are imprinted with wrong identification markings. The affected lot numbers are KDT0124004, KDT0124005, and KDT0124006, which expire on August 31, 2026.
The product was distributed nationwide throughout the United States. No illnesses or injuries have been reported in connection with this defect.
The recalled product
- Product
- Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01.
- Manufacturer
- Akron Pharma, Inc.
- Category
- Drug — Acetaminophen / Tablet
- Hazard
- Affected units
- 14,825
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #s: KDT0124004
- KDT0124005
- KDT0124006
- Exp 08/31/2026
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Akron Pharma, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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