Acetaminophen tablets recalled for incorrect imprinting
Akron Pharma is recalling Acetaminophen Regular Strength 325 mg tablets due to incorrect imprinting on the tablets. The recall involves approximately 6,429 bottles distributed nationwide.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III recall for a labeling and identification issue with no reported illnesses or injuries, making this a low-risk precautionary recall.
Plain-English summary
Akron Pharma, Inc. is recalling Acetaminophen Regular Strength tablets, 325 mg, in bottles of 100 tablets. The tablets are imprinted with incorrect identification. The affected product is lot number KDT0124001 with an expiration date of August 31, 2026, NDC number 71399-8024-01.
Approximately 6,429 bottles were distributed nationwide throughout the United States. This is a Class III recall issued by the U.S. Food and Drug Administration.
The recalled product
- Product
- Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8024-01 .
- Manufacturer
- Akron Pharma, Inc.
- Category
- Drug
- Hazard
- Affected units
- 6,429
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 (2)
- Lot #: KDT0124001
- 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.
See all 7 products in this recall →Related recalls
Same manufacturer · Akron Pharma, Inc.
See all →- LowDiphenhydramine HCl 50 mg Capsules Recalled Due to Incorrect ID Imprinting
FDA (Drugs) · 2025-01-22
- ModerateAcetaminophen 325 mg tablets recalled for incorrect imprinting
FDA (Drugs) · 2025-01-22
- LowDiphenhydramine HCl Capsules Recalled Due to Wrong ID Imprinting
FDA (Drugs) · 2025-01-22
- ModerateAcetaminophen Extra Strength tablets recalled for incorrect product imprint identification
FDA (Drugs) · 2025-01-22
- ModerateDiphenhydramine HCl Capsules Recalled Due to Wrong Imprinting
FDA (Drugs) · 2025-01-22
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- LowMagellan LeadCare II Blood Lead Test Kit Recall for Labeling Error
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
- SevereDeano's Pasta Recalls Pear and Pecorino Ravioli for Undeclared Lobster
FDA (Food) · 2026-10-21
Similar recalls
- ModerateAcetaminophen 325 mg tablets recalled for missing imprint
FDA (Drugs) · 2022-08-24
- ModerateAkorn Pharma recalls Acetaminophen 500 mg tablets with missing imprints
FDA (Drugs) · 2022-08-24
- SevereMedline Acetaminophen Tablets Recalled for Incorrect Strength Labeling
FDA (Drugs) · 2016-02-24
- SevereAcetaminophen tablets incorrectly labeled with aspirin drug facts information
FDA (Drugs) · 2024-08-14
- CriticalMedline Recalls Mislabeled Acetaminophen Extra-Strength Pain Reliever Tablets
FDA (Drugs) · 2016-02-24
- LowAcetaminophen Extra Strength tablets recalled for incorrect enteric-coated labeling
FDA (Drugs) · 2021-07-28