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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

PharMEDium Services, LLC.: Hydromorphone HCl Injection Recalled for Excessive Potency

Agency Publication Date: November 14, 2017
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Summary

PharMEDium Services, LLC. is recalling 499 syringes of Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection (1 mL) because testing revealed the medication is superpotent, meaning it contains more active drug than specified. This prescription pain medication is packaged in syringes and was distributed to healthcare facilities in California and Illinois. Consumers should immediately contact their healthcare provider or pharmacist regarding this recall, as the use of higher-than-intended doses of this medication poses serious health risks.

Risk

The drug is superpotent and failed potency specifications, which means patients could receive a much higher dose of hydromorphone than prescribed. An overdose of this potent opioid can lead to severe respiratory depression, extreme sedation, and potentially life-threatening complications.

What You Should Do

  1. Identify if you have the affected medication by checking the syringe label for Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection (1 mL) with NDC 61553-352-40.
  2. Check the syringe for Lot number 172820134M and an expiration date of 01/18 (January 2018).
  3. Immediately contact your healthcare provider or pharmacist if you believe you have received this medication or if you have any health concerns.
  4. Return any unused syringes from Lot 172820134M to the pharmacy or place of purchase for a refund.
  5. Contact PharMEDium Services, LLC. at their Memphis, Tennessee headquarters for further instructions regarding the return of this product.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return product for refund.

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

Affected Products

Product: Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection (1 mL)
Model:
NDC 61553-352-40
Recall #: D-0080-2018
Lot Numbers:
172820134M (Exp 01/18)
Date Ranges: Expiration Date: January 2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78503
Status: Resolved
Manufacturer: PharMEDium Services, LLC.
Sold By: Hospitals; Clinics; Healthcare Facilities
Manufactured In: United States
Units Affected: 499 syringes
Distributed To: California, Illinois

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.