Diphenhydramine HCl Capsules Recalled Due to Wrong Imprinting
Akron Pharma is recalling Diphenhydramine HCl 25 mg capsules nationwide because the capsules are imprinted with incorrect identification. Consumers should stop using the affected product.
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 involving minor labeling errors (incorrect imprinting). No illnesses or injuries have been reported, making this a precautionary recall with a theoretical hazard.
Plain-English summary
Akron Pharma, Inc. is recalling Diphenhydramine HCl 25 mg capsules (100 capsules per bottle) due to incorrect imprinting on the capsules.
The capsules are imprinted with wrong identification markings.
The affected product includes Lot KDC0124001A with expiration date 09/30/2026, which was distributed nationwide in the United States. Approximately 7,198 bottles are affected.
Consumers who have purchased this product should stop using it immediately and consult with their healthcare provider or pharmacist for guidance on proper disposal or replacement.
The recalled product
- Product
- Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1.
- Manufacturer
- Akron Pharma, Inc.
- Category
- Drug
- Hazard
- Affected units
- 7,198
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: KDC0124001A 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.
See all 7 products in this recall →Related recalls
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