Apollo Care Fentanyl 500mcg Injection Recall: Lack of Sterility Risk
Apollo Care recalls Fentanyl 500mcg injections due to lack of assurance of sterility. This could cause infections if used improperly. Contact the manufacturer for details.
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Lack of Assurance of Sterility
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What happened, in plain English
Apollo Care is recalling Fentanyl 500mcg injections that may not be sterile, posing infection risks. This is a serious issue for medical use only. Read more at govinfonow.com/recall/32140-apollo-care-fentanyl-500mcg-injection-recall-lack-of-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32140-apollo-care-fentanyl-500mcg-injection-recall-lack-of-sterility-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0409-2025
Cite this page
“Apollo Care Fentanyl 500mcg Injection Recall: Lack of Sterility Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32140-apollo-care-fentanyl-500mcg-injection-recall-lack-of-sterility-risk. Based on FDA recall #D-0409-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0409-2025%22&limit=1).
Why it’s dangerous
The injection may not be sterile, which can lead to infections if used in medical procedures. This is especially dangerous for epidural injections where contamination could cause serious health issues.
Who’s affected
Healthcare providers and patients using this injection for epidural procedures. Those with the specific lot number are most at risk.
How to tell if you have this one
Check for the lot number AC-016878 on the label. The product is a sterile, single-use injection for epidural use only, with an expiration date of June 16, 2025.
- Brand
Apollo Care- Category
Drug
What to do — step by step
Stop Using Now
Immediately discard the product if you have it, as it may not be sterile and could cause infections.
Where it went and when
Where it was distributed
Distributed in Missouri.
FDA distribution: “MO” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Missouri.
Recall timeline
FDA published this recall 29 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-0409-2025 (April 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0409-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.