Diphenhydramine HCL Liquid — Class II drug recall D-1430-2019
Terminated recall by H J Harkins Company Inc dba Pharma Pac, reported 2019-07-03, distributed nationwide. Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.
| Recall number | D-1430-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | H J Harkins Company Inc dba Pharma Pac, Grover Beach, CA, United States |
| Recall initiated | 2019-06-24 |
| Classified | 2019-06-27 |
| Reported by FDA | 2019-07-03 |
| Terminated | 2023-05-24 |
| Distributed | Nationwide (US) |
| Quantity | 12 bottles |
| Reason classes | microbial contamination, sterility |
| Pathogens | burkholderia |
| NDC | 52959-0123-03 |
| Lot numbers | 12/19, DHI56M |
Product
Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.
Reason for recall
Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
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-1430-2019. 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.