Diphenhydramine HCl 25 mg — Class III drug recall D-0674-2017
Terminated recall by InnovaGel, reported 2017-04-26, distributed in NY. Subpotent
| Recall number | D-0674-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | InnovaGel, Miami, FL, United States |
| Recall initiated | 2017-01-05 |
| Classified | 2017-04-19 |
| Reported by FDA | 2017-04-26 |
| Terminated | 2021-09-29 |
| Distributed | NY |
| Quantity | 7,920,177 capsules |
| Reason classes | potency |
| Lot numbers | 1404811, 1409802, 1502817, 1504808, 1509810, 1511802, 1603801 |
| Expiration dates | 2018-12-12 |
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
Reason for recall
Subpotent
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0674-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.