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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

American Pharmaceutical Ingredients LLC: Oxytocin and Sermorelin Acetate Recalled Due to Unsupported Expiration Dates

Agency Publication Date: March 12, 2018
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Summary

American Pharmaceutical Ingredients LLC is recalling 1,481 units of Oxytocin and Sermorelin Acetate powder due to stability data that does not support the expiration dates listed on the labels. This means the drugs may lose their effectiveness or change in chemical composition before the date printed on the packaging. These products were distributed nationwide in the United States and were sold in various bottle sizes, including 1g, 5g, and 10g containers. Consumers should immediately check their medication supplies for the specific lot numbers and NDC codes involved in this recall to ensure they are not using products with unreliable shelf lives.

Risk

The manufacturer's stability data does not support the labeled expiration dates, which may result in the medication being less potent or having an altered chemical profile than intended when used. This lack of stability data can lead to patients receiving an incorrect dosage of the active pharmaceutical ingredient, potentially resulting in ineffective treatment for their medical conditions.

What You Should Do

  1. Check your medication bottles for Oxytocin USP powder (1g-bottle) with NDC 58597-7042-3 and Lot number 012517-1R.
  2. Check your medication bottles for Sermorelin Acetate powder in 1g (NDC 58597-8092-1), 5g (NDC 58597-8092-2), or 10g (NDC 58597-8092-4) sizes.
  3. For Sermorelin Acetate, verify if your bottle matches these specific Lot and Expiration date combinations: 071916-1 (Exp. 07/08/2018), 080516-1 (Exp. 07/22/2018), 080516-2 (Exp. 07/22/2018), 101216-1 (Exp. 09/15/2018), or 011917C-1 (Exp. 09/15/2018).
  4. Contact your healthcare provider or pharmacist immediately to discuss alternative treatments and to determine if your current supply is safe to use.
  5. Return any unused or affected product to the pharmacy or place of purchase for a refund.
  6. Contact American Pharmaceutical Ingredients LLC at their Waterford, Michigan location for further instructions regarding the return process.
  7. Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Your Remedy Options

๐Ÿ’ฐFull Refund

Refund for unused medication.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Oxytocin USP, powder (1g-bottle)
Model:
NDC 58597-7042-3
Lot Numbers:
012517-1R
Product: Sermorelin Acetate, powder (1 GM-bottle)
Model:
NDC 58597-8092-1
Lot Numbers:
071916-1 (Exp. 07/08/2018)
080516-1 (Exp. 07/22/2018)
080516-2 (Exp. 07/22/2018)
101216-1 (Exp. 09/15/2018)
011917C-1 (Exp. 09/15/2018)
Date Ranges: 07/08/2018, 07/22/2018, 09/15/2018
Product: Sermorelin Acetate, powder (5 GM-bottle)
Model:
NDC 58597-8092-2
Lot Numbers:
071916-1 (Exp. 07/08/2018)
080516-1 (Exp. 07/22/2018)
080516-2 (Exp. 07/22/2018)
101216-1 (Exp. 09/15/2018)
011917C-1 (Exp. 09/15/2018)
Date Ranges: 07/08/2018, 07/22/2018, 09/15/2018
Product: Sermorelin Acetate, powder (10 GM-bottle)
Model:
NDC 58597-8092-4
Lot Numbers:
071916-1 (Exp. 07/08/2018)
080516-1 (Exp. 07/22/2018)
080516-2 (Exp. 07/22/2018)
101216-1 (Exp. 09/15/2018)
011917C-1 (Exp. 09/15/2018)
Date Ranges: 07/08/2018, 07/22/2018, 09/15/2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79420
Status: Resolved
Manufacturer: American Pharmaceutical Ingredients LLC
Sold By: Pharmacies; Healthcare Providers
Manufactured In: United States
Units Affected: 2 products (21 g; 1460 GM)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.