CLASS II Drug recall · Reported 4 Sep 2019 · FDA Enforcement Report
Relpax (eletriptan HBr) tablets, 40 mg recalled by Pfizer
Pfizer is recalling Relpax (eletriptan HBr) tablets, 40 mg, distributed nationwide in the US. The recall was initiated on 14 Aug 2019 and the FDA has classified it as Class II.
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
Timeline
| 14 Aug 2019 | Recall initiated by company | |
| 28 Aug 2019 | Classified by FDA | +14 days |
| 4 Sep 2019 | 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
Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA and Puerto Rico.
Questions about this recall
Is Relpax (eletriptan HBr) tablets, 40 mg recalled?
Yes. Pfizer recalled Relpax (eletriptan HBr) tablets, 40 mg on 14 Aug 2019. The recall is Class II and its status is Terminated. Recall number D-1845-2019.
Why was it recalled?
Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
Which lots are affected?
Lot #: a) AR5407, Exp 2022 FEB; b) CD4565, Exp 2022 FEB
Where was it sold?
Nationwide in the USA and Puerto Rico.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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