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Drug recall · FDA · Published February 6, 2019

Advanced Pharma Inc. recalls Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1002 mL

Advanced Pharma recalls oxytocin injectable solution with potential higher oxytocin concentrations than labeled. This may cause unsafe effects during medical use. Check product details to determine if affected.

🇺🇸 FDA recall #D-0498-2019DrugAdvanced 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 oxytocin injectable solution that may contain higher oxytocin concentrations than labeled. This could lead to unsafe medical effects if used as intended. Read more at govinfonow.com/recall/39207-advanced-pharma-oxytocin-solution-recall-potent-oxytocin-concentration-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/39207-advanced-pharma-oxytocin-solution-recall-potent-oxytocin-concentration-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0498-2019

Cite this page

“Advanced Pharma Oxytocin Solution Recall: Potent Oxytocin Concentration Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39207-advanced-pharma-oxytocin-solution-recall-potent-oxytocin-concentration-risk. Based on FDA recall #D-0498-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0498-2019%22&limit=1).

Why it’s dangerous

The product may contain oxytocin concentrations exceeding what's listed on the label. This could cause unintended medical effects, especially during labor or other medical procedures where precise dosing is critical.

Who’s affected

Healthcare professionals and patients using this oxytocin solution for medical purposes. Those with specific medical conditions requiring precise oxytocin dosing are at higher risk.

How to tell if you have this one

Look for the product name 'Oxytocin 20 Units added to NS 1000 mL' with NDC 42852-703-99. Check for lot numbers 12/14/18 1482 70399P or 12/14/18 1610 70399P with a BUD of 02/27/19.

  • Brand
    Advanced Pharma
  • Category
    Drug
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class III
  • Status
    Terminated
  • Distribution
    Nationwide in the USA.
Recall numberProduct, codes & lotsQuantity
D-0497-2019Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1001 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-730-99.; Lot: 12/20/18 1056 73099P, BUD: 02/03/201912 bags
D-0498-2019Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 1002 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-703-99.; Lots: 12/14/18 1482 70399P, BUD: 02/27/19; 12/14/18 1610 70399P, BUD: 02/27/19672 bags
D-0499-2019Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable Solution, Approximately 503 mL Sterile single use bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC 42852-706-50.; Lots: 11/27/18 3177 70650P, BUD: 02/10/2019; 11/27/18 6618 70650P, BUD: 02/10/2019; 11/28/18 7716 70650P, BUD: 02/12/19; 12/31/18 5698 70650P, BUD: 03/16/191460 bottles
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the product by checking the NDC code 42852-703-99 and lot numbers listed in the recall notice.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall states the product may contain higher oxytocin concentrations than labeled, so it's not safe to use as intended without checking the recall.

What should I do if I have this product?

The recall does not specify a remedy, so contact Advanced Pharma directly for guidance.

How can I tell if I have the recalled product?

Look for the NDC code 42852-703-99 and lot numbers 12/14/18 1482 70399P or 12/14/18 1610 70399P with a BUD of 02/27/19.

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-0498-2019 — Advanced Pharma Advanced Pharma

Hello,

I own a Advanced Pharma that is covered by recall D-0498-2019 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-0498-2019 (February 6, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0498-2019 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