Reported Apr 26, 2017 · Terminated

Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W.…

InnovaGel

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: InnovaGel · 14193 Sw 119th Ave · Miami, FL · 33186-6013

Is this the product you have?

    • 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
Lot codes and dates
    • Batch #: 1404811
    • 1409802
    • 1502817
    • 1504808
    • 1509810
    • 1511802
    • 1603801
    • Exp. 12/12/2018
Amount recalled
Approximately 7,920,177 capsules

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

Subpotent

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 29, 2021 · Data as of Sep 19, 6:32 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.