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Drug recall · FDA · Published March 7, 2018

American Pharmaceutical Ingredients LLC recalls Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3

Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.

🇺🇸 FDA recall #D-0591-2018DrugAmerican Pharmaceutical Ingredients LLC ›
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Recalling firmAmerican Pharmaceutical Ingredients LLC6650 Highland Rd Ste 302 · Waterford, MI 48327-1665
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.
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We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.

Source Page by GovInfoNow · govinfonow.com/recall/40786-american-pharmaceutical-ingredients-llc-recalls-oxytocin-usp-powder-1g-bottle · Recall date March 7, 2018 · FDA enforcement record: FDA #D-0591-2018

Cite this page

“American Pharmaceutical Ingredients LLC recalls Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3.” GovInfoNow, recall dated March 7, 2018. https://govinfonow.com/recall/40786-american-pharmaceutical-ingredients-llc-recalls-oxytocin-usp-powder-1g-bottle. Based on FDA recall #D-0591-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0591-2018%22&limit=1).

How to tell if you have this one

  • Brand
    American Pharmaceutical Ingredients LLC
  • Category
    Drug
FDA recall event · 2 products

All 2 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 II
  • Status
    Terminated
  • Distribution
    Nationwide in the USA.
Recall numberProduct, codes & lotsQuantity
D-0591-2018Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3; Lot 012517-1R21 g
D-0592-2018Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharmaceutical Ingredients; Lots: 071916-1, Exp. 07/08/2018; 080516-1, 080516-2, Exp. 07/22/2018; 101216-1, 011917C-1, Exp. 09/15/2018;1460 GM
Take action

Contact American Pharmaceutical Ingredients LLC

We’ve drafted a message you can send American Pharmaceutical Ingredients LLC to request your refund or repair — edit it as you like.

Subject: Recall D-0591-2018 — American Pharmaceutical Ingredients LLC American Pharmaceutical Ingredients LLC recalls Oxytocin US

Hello,

I own a American Pharmaceutical Ingredients LLC recalls Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3 that is covered by recall D-0591-2018 from American Pharmaceutical Ingredients LLC.

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-0591-2018 (March 7, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0591-2018 to see it in context.
  • 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