RELPAX — Class II drug recall D-1845-2019
Terminated recall by Pfizer Inc., reported 2019-09-04, distributed nationwide. Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
| Recall number | D-1845-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2019-08-14 |
| Classified | 2019-08-28 |
| Reported by FDA | 2019-09-04 |
| Terminated | 2023-06-20 |
| Distributed | Nationwide (US) |
| Reason classes | microbial contamination, sterility |
| Pathogens | burkholderia, pseudomonas |
| NDC | 00049-2340-05, 00049-2340-45 |
Product
RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per carton, NDC 0049-2340-45; b) 12-count (2 cards x 6 tablets) per carton, NDC 0049-2340-05, Rx only, Made in Ireland, Distributed by Pfizer Roerig, Division of Pfizer Inc., NY, NY 10017.
Reason for recall
Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
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-1845-2019. 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.