Diphenhydramine Oral Liquid Alcohol Free — Class II drug recall D-1520-2019
Terminated recall by Geritrex, LLC, reported 2019-07-31, distributed nationwide. cGMP Deviations: Products may have microbial contamination.
| Recall number | D-1520-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Geritrex, LLC, Middletown, NY, United States |
| Recall initiated | 2019-05-31 |
| Classified | 2019-07-25 |
| Reported by FDA | 2019-07-31 |
| Terminated | 2024-02-02 |
| Distributed | Nationwide (US) |
| Quantity | 8,645 bottles |
| Reason classes | microbial contamination, cgmp |
| NDC | 53807-0204-04 |
| Lot numbers | 6/19, 70606 |
Product
Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-204-04
Reason for recall
cGMP Deviations: Products may have microbial contamination.
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-1520-2019. 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.