CLASS III Drug recall · Reported 26 Apr 2017 · FDA Enforcement Report
Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule bulk recalled
InnovaGel is recalling Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule bulk drums, aenova/Swiss Caps USA, distributed in New York. The recall was initiated on 5 Jan 2017 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0674-2017
- FDA event ID
- 76933
- Recalling firm
- InnovaGel, Miami, FL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Jan 2017
- FDA classified
- 19 Apr 2017
- Reported
- 26 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
- Drug class
- Allergy Medication
Timeline
| 5 Jan 2017 | Recall initiated by company | |
| 19 Apr 2017 | Classified by FDA | +104 days |
| 26 Apr 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
NY only
Questions about this recall
Why was it recalled?
Subpotent
Which lots are affected?
Batch #: 1404811, 1409802, 1502817, 1504808, 1509810, 1511802, 1603801, Exp. 12/12/2018.
Where was it sold?
NY only
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 76933| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Dye Free Allergy Softgel Gelatin Capsule bulk drums recalled | InnovaGel | Potency & Assay | NY |
More recalls from InnovaGel
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Dye Free Allergy Softgel Gelatin Capsule bulk drums recalled | InnovaGel | Potency & Assay | NY |
Other Diphenhydramine recalls
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diphenhydramine 18mg in NS Syringe, antihistamine recalled | Sentara Infusion Services | Sterility | Nationwide |
| Drug | CLASS II | Diphenhydramine HCl Oral Solution, 25 mg / cup recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Diphenhydramine HCl Oral Solution 12.5 mg / cup recalled | Plastikon Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Diphenhydramine HCl oral solution, USP, 25 mg/ UD recalledDiphenhydramine Hydrochloride | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Banophen Diphenhydramine HCl 25 mg Antihistamine recalledDiphenhydramine Hydrochloride | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |