InnovaGel Diphenhydramine HCl 25mg Capsules: Subpotent Risk
InnovaGel recalls 15,000-count bulk diphenhydramine capsules due to subpotent potency. This may cause ineffective treatment. Check product code MSU0048P or NDC 6897080284 for affected items.
Lower-risk recall
Subpotent
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What happened, in plain English
InnovaGel is recalling 15,000-count bulk diphenhydramine capsules because they may not contain enough active ingredient to be effective. This could lead to treatment failure for allergies or insomnia. Read more at govinfonow.com/recall/42094-innovagel-diphenhydramine-hcl-25mg-capsules-subpotent-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42094-innovagel-diphenhydramine-hcl-25mg-capsules-subpotent-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0674-2017
Cite this page
“InnovaGel Diphenhydramine HCl 25mg Capsules: Subpotent Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42094-innovagel-diphenhydramine-hcl-25mg-capsules-subpotent-risk. Based on FDA recall #D-0674-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0674-2017%22&limit=1).
Why it’s dangerous
The capsules have subpotent potency, meaning they contain less active medication than intended. This could result in the medication not working as expected for allergy or sleep symptoms.
Who’s affected
People who own or use the recalled diphenhydramine capsules for allergies or sleep issues. Those with higher doses or specific medical conditions may be at slightly higher risk.
How to tell if you have this one
Check for product code MSU0048P or NDC 6897080284 on the packaging. The capsules were sold in bulk drums with batch numbers 1404811 through 1603801, expiring December 2018.
- Brand
InnovaGel- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
NY only
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0674-2017 | 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; Batch #: 1404811, 1409802, 1502817, 1504808, 1509810, 1511802, 1603801, Exp. 12/12/2018. | Approximately 7,920,177 capsules |
| D-0675-2017 | 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; Batch #: 1508803,1602801, 1602802, 1604801, 1604802, 1606801, 1606802, 1606803, 1606804, Exp. 08/03/2018. | 9,992,768 softgels |
What to do — step by step
Check Product Details
Look for product code MSU0048P or NDC 6897080284 on the packaging to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed in New York.
FDA distribution: “NY only” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New York.
Recall timeline
FDA terminated this recall 4.7 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0674-2017 (January 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0674-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.