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Drug recall · FDA · Published February 6, 2019

Advanced Pharma Inc. recalls Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile

Advanced Pharma recalls Fentanyl injectable solution with incorrect expiration date labeling. This may lead to medication errors if used after the wrong expiration date. Contact the manufacturer for details.

🇺🇸 FDA recall #D-0496-2019DrugAdvanced Pharma ›
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Contact the company & request your remedy

Recalling firmAdvanced Pharma Inc.9265 Kirby Dr · Houston, TX 77054-2520
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Advanced Pharma is recalling a specific Fentanyl injection product due to incorrect expiration date labeling. This could cause medication errors if users rely on the wrong expiration date. Read more at govinfonow.com/recall/39211-advanced-pharma-fentanyl-solution-recall-incorrect-expiration-date-labeling.

Source Summary by GovInfoNow · govinfonow.com/recall/39211-advanced-pharma-fentanyl-solution-recall-incorrect-expiration-date-labeling · Updated October 5, 2026 · FDA enforcement record: FDA #D-0496-2019

Cite this page

“Advanced Pharma Fentanyl Solution Recall: Incorrect Expiration Date Labeling.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39211-advanced-pharma-fentanyl-solution-recall-incorrect-expiration-date-labeling. Based on FDA recall #D-0496-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0496-2019%22&limit=1).

Why it’s dangerous

The product has an incorrect expiration date label, which could lead to users administering medication after it has expired. This might cause ineffective treatment or potential safety issues if the medication is no longer stable.

Who’s affected

Prescription users of this Fentanyl injection product. Those who have the specific lot number and expiration date listed in the recall are most at risk.

How to tell if you have this one

Check for the product name: Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill Injectable Solution, Sterile. Look for the lot number 12/31/18 0555 21072S and expiration date 3/31/2019.

  • Brand
    Advanced Pharma
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Expiration Date

    Verify the expiration date on the product label against the recall's stated expiration date of 3/31/2019.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The product may have an incorrect expiration date label, which could lead to medication errors. Do not use if the expiration date appears wrong.

What should I do if I have this product?

Check the expiration date on the product label. If it matches the recall's stated expiration date of 3/31/2019, it is safe to use. Otherwise, contact Advanced Pharma for guidance.

How can I get more information?

Contact Advanced Pharma at (877) 794-0404 or visit their website for more details.

Take action

Contact Advanced Pharma

We’ve drafted a message you can send Advanced Pharma to request your refund or repair — edit it as you like.

Subject: Recall D-0496-2019 — Advanced Pharma Advanced Pharma

Hello,

I own a Advanced Pharma that is covered by recall D-0496-2019 from Advanced Pharma.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-0496-2019 (February 6, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0496-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA