Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-0674-2017·Announced 2017-04-26

InnovaGel Recalls Subpotent Diphenhydramine HCl Softgel Capsules

InnovaGel is recalling approximately 7.9 million subpotent Diphenhydramine HCl 25 mg softgel capsules distributed in New York.

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: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences, and the issue is a subpotent product rather than a contamination or labeling error involving allergens.

Plain-English summary

InnovaGel is voluntarily recalling approximately 7,920,177 Diphenhydramine HCl 25 mg softgel gelatin capsules. The product is sold in 15,000-count bulk drums and is manufactured by aenova/Swiss Caps USA, Inc. The recall was initiated on January 5, 2017, and was classified as Class III by the FDA.

The reason for the recall is that the capsules are subpotent, meaning they do not contain the full amount of the active ingredient stated on the label. The affected product is identified by Product Code MSU0048P and NDC 6897080284. Specific batch numbers include 1404811, 1409802, 1502817, 1504808, 1509810, 1511802, and 1603801, all with an expiration date of December 12, 2018.

The affected capsules were distributed only in New York. The recall status is currently terminated. Consumers and healthcare providers should check their inventory for these specific batch numbers and contact the recalling firm for further instructions.

The recalled product

Product: Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0048P, NDC 6897080284
Manufacturer: InnovaGel
Category: Drug — Antihistamine
Hazard: subpotent-drug
Affected units: 7,920,177

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 (8)

Batch #: 1404811
1409802
1502817
1504808
1509810
1511802
1603801
Exp. 12/12/2018.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by InnovaGel 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 2 products in this recall →

Same manufacturer · InnovaGel

See all →

Low
InnovaGel Recalls Subpotent Dye Free Allergy Softgel Gelatin Capsules
FDA (Drugs) · 2017-04-26

Same hazard · subpotent drug