Diphenhydramine HCl Capsules Recalled Due to Wrong ID Imprinting
Akron Pharma recalls 456 bottles of Diphenhydramine HCl 25 mg capsules due to incorrect ID imprinted on the capsules.
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: This is an FDA Class III recall with no reported illnesses or injuries. The hazard is purely a labeling and identification issue. FDA Class III recalls are typically scored 1 or 2; with no reported harm and a documentation-only issue, this recall merits a Low score.
Plain-English summary
Akron Pharma, Inc. is recalling Diphenhydramine HCl 25 mg capsules (1000 capsules per bottle) in Lot KDC0124002B with expiration 09/30/2026. The recall affects 456 bottles distributed nationwide in the United States.
The capsules were imprinted with incorrect identification information. This is a labeling issue that affects proper identification of the medication.
Consumers who have this product should verify the lot number KDC0124002B and expiration date 09/30/2026 on their bottles. Anyone with the recalled product should consult with their pharmacist or contact Akron Pharma for further instructions.
The recalled product
- Product
- Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E., Suite 117, Fairfield, NJ 07004, NDC 71399-8028-2.
- Manufacturer
- Akron Pharma, Inc.
- Category
- Drug
- Hazard
- Affected units
- 456
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 (1)
- Lot: KDC0124002B Exp 09/30/2026
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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