Pfizer Recalls RELPAX 40mg Tablets Due to Microbial Contamination
Pfizer recalls specific lots of RELPAX (eletriptan HBr) 40 mg tablets due to microbial contamination with Burkholderia and Pseudomonas. Check your NDC and lot numbers.
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Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
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What happened, in plain English
Pfizer Inc. is recalling specific lots of RELPAX (eletriptan HBr) tablets, 40 mg, because they are contaminated with the bacteria Burkholderia and Pseudomonas. The affected products include both 6-count and 12-count cartons distributed nationwide in the USA and Puerto Rico. The record does not specify a remedy or action for consumers at this time. Read more at govinfonow.com/recall/38085-pfizer-recalls-relpax-40mg-tablets-due-to-microbial-contamination.
Source Summary by GovInfoNow · govinfonow.com/recall/38085-pfizer-recalls-relpax-40mg-tablets-due-to-microbial-contamination · Updated October 11, 2026 · FDA enforcement record: FDA #D-1845-2019
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“Pfizer Recalls RELPAX 40mg Tablets Due to Microbial Contamination.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/38085-pfizer-recalls-relpax-40mg-tablets-due-to-microbial-contamination. Based on FDA recall #D-1845-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1845-2019%22&limit=1).
Why it’s dangerous
The recalled non-sterile products are contaminated with Burkholderia and Pseudomonas bacteria. Ingesting medication contaminated with these microbes can pose a health risk to the user, although specific injury details are not provided in this record.
Who’s affected
Individuals who have been prescribed RELPAX (eletriptan HBr) 40 mg tablets and possess the specific lots listed in the recall. Consumers in the USA and Puerto Rico who purchased these items are potentially affected.
How to tell if you have this one
Check if you have RELPAX (eletriptan HBr) tablets, 40 mg, Rx only, made in Ireland and distributed by Pfizer Roerig. Look for NDC 0049-2340-45 (6-count) with Lot # AR5407 or NDC 0049-2340-05 (12-count) with Lot # CD4565.
- Brand
Pfizer- Category
Drug
What to do — step by step
Check Your Medication
Verify if your RELPAX tablets match the recalled NDC numbers (0049-2340-45 or 0049-2340-05) and lot numbers (AR5407 or CD4565).
Consult Your Doctor
Contact your healthcare provider to discuss whether you should stop taking the medication or obtain a replacement, as no specific remedy is listed in this record.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.8 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1845-2019 (August 14, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1845-2019 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.