Revive Rx HCG Injection Recall: Bacterial Contamination Risk
Revive Rx recalls HCG 6,000iu injection vials due to bacterial contamination. Check lot numbers and consult your provider immediately.
Stop using this now
Non-sterility; bacterial contamination identified as Paenibacillus lautus.
Contact the company
What happened, in plain English
Revive Rx LLC is recalling a specific lot of HCG 6,000iu (lyo) Human Chorionic Gonadotropin Injection vials because they are not sterile. The product has been identified as contaminated with the bacteria Paenibacillus lautus. This recall affects 115 vials distributed nationwide. Read more at govinfonow.com/recall/35225-revive-rx-hcg-injection-recall-bacterial-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/35225-revive-rx-hcg-injection-recall-bacterial-contamination-risk · Updated October 10, 2026 · FDA enforcement record: FDA #D-0648-2022
Cite this page
“Revive Rx HCG Injection Recall: Bacterial Contamination Risk.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/35225-revive-rx-hcg-injection-recall-bacterial-contamination-risk. Based on FDA recall #D-0648-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0648-2022%22&limit=1).
Why it’s dangerous
The recalled vials failed sterility tests and contain Paenibacillus lautus bacteria. Introducing contaminated medication into the body via injection can lead to serious infections or other adverse health effects.
Who’s affected
Patients who have received or possess HCG 6,000iu injection vials compounded by Revive Rx Pharmacy. Individuals using this medication for subcutaneous or intramuscular injections are at risk of infection from bacterial contamination.
How to tell if you have this one
Look for HCG 6,000iu (lyo) Human Chorionic Gonadotropin Injection vials compounded by Revive Rx. The specific recalled lot number is 631359 with a Beyond Use Date (BUD) of 05/01/2022. The National Drug Code (NDC) is 88888-1739-01.
- Brand
Revive Rx- Category
Drug
What to do — step by step
Stop using the medication
Do not use any vials matching the recalled lot number due to bacterial contamination risks.
Contact your healthcare provider
Reach out to the prescribing doctor or pharmacist immediately for guidance on next steps and potential replacement.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the US.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class I
- 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-0648-2022 (February 11, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0648-2022 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 10, 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.