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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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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

Amgen, Inc.: Procrit (epoetin alfa) Recalled for Glass Flakes in Vials

Agency Publication Date: September 19, 2017
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Summary

Amgen is recalling approximately 275,380 vials of Procrit (epoetin alfa) 10,000 units/mL because glass flakes, known as lamellae, were discovered in the medication during a quality inspection. These flakes can form when the glass vial surface breaks down over time. If the contaminated medication is injected, the glass particles can cause serious health issues including blood clots, swelling of the veins, and life-threatening reactions. This recall affects single-use vials sold in boxes of 6 or 25 with expiration dates in July 2018. Consumers should contact their doctor or pharmacist immediately for guidance and a refund.

Risk

The injection of glass lamellae can cause localized irritation or swelling, but more seriously, the particles can travel through the bloodstream and cause blood clots or blockages in the lungs, heart, or brain. These flakes can also trigger severe inflammatory or allergic reactions that may be life-threatening.

What You Should Do

  1. Check your medication to see if you have Procrit (epoetin alfa) 10,000 units/mL vials from the affected lots: G290530A or G290531A.
  2. Verify the expiration date and NDC code on the packaging; affected boxes of 6 vials carry NDC 59676-310-01 and affected boxes of 25 vials carry NDC 59676-310-02, both with an expiration date of 07/18.
  3. If you have an affected vial, do not use it; contact your healthcare provider or pharmacist immediately to discuss alternative treatment and to report any adverse health effects.
  4. Return any unused vials from these specific lots to your pharmacy to receive a full refund.
  5. Contact the manufacturer, Amgen, Inc., at 1 Amgen Center Dr, Thousand Oaks, California, for further instructions regarding this recall.
  6. For additional information or to report concerns, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Refund for unused vials

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

Affected Products

Product: Procrit (epoetin alfa), 10,000 units/mL (Box of 6 single use 1 mL vials)
Model:
NDC 59676-310-01
D-1173-2017
Lot Numbers:
G290530A (Exp 07/18)
Date Ranges: 07/18
Product: Procrit (epoetin alfa), 10,000 units/mL (Box of 25 single use 1 mL vials)
Model:
NDC 59676-310-02
D-1173-2017
Lot Numbers:
G290531A (Exp 07/18)
Date Ranges: 07/18

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78110
Status: Resolved
Manufacturer: Amgen, Inc.
Sold By: Pharmacies; Hospitals
Manufactured In: United States
Units Affected: 275,380 vials
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.

Find an Attorney

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.