Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class III · Low risk Terminated Initiated Jan 5, 2017 (10 years ago)

Dye Free Allergy Softgel Gelatin Capsule

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Subpotent

Cause type: Wrong potency / content

Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.

What was recalled

Dye Free Allergy Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0067P, NDC 6897080284

Affected NDC 68970-8028-04

Compare with the code on your package — it is the most precise check available.

Recalling firm
InnovaGel
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0675-2017 · FDA notice

Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other recalls by InnovaGel

All 2017 recalls

Other wrong potency / content recalls from 2017

All wrong potency / content recalls
Class II · Moderate risk

Viokace (pancrelipase)

Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile.

Terminated Wrong potency / content Allergan NDC 58914-117-10 D-0154-2018