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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

Akorn, Inc.: Gentamicin Sulfate Ophthalmic Solution Recalled for High Impurity Levels

Agency Publication Date: March 8, 2019
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Summary

Akorn, Inc. is recalling 51,456 bottles of Gentamicin Sulfate Ophthalmic Solution, USP, 0.3% (5 mL), a prescription antibiotic eye drop used to treat bacterial infections. Testing at the 18-month mark revealed that the medication exceeded allowed limits for impurities and degradation, which means the product is breaking down faster than expected. Consumers should contact their healthcare provider or pharmacist regarding this recall and return any unused portions of the affected medication to their pharmacy.

Risk

The presence of high levels of impurities or degradation products in eye drops may reduce the effectiveness of the antibiotic treatment or potentially cause unexpected irritation or adverse reactions during use.

What You Should Do

  1. Identify your medication by checking the label for Gentamicin Sulfate Ophthalmic Solution, USP, 0.3% in 5 mL bottles with NDC 17478-283-10.
  2. Check the bottle and packaging for Lot number 7B71A with an expiration date of 01/2020.
  3. Contact your healthcare provider or pharmacist immediately to discuss alternative treatments if you are currently using the affected medication.
  4. Return any unused product from the affected lot to your pharmacy for a refund.
  5. Contact Akorn, Inc. at 1-888-723-3332 or visit www.fda.gov/safety/recalls for further instructions regarding this recall.
  6. For additional questions or to report a problem, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare consultation and pharmacy return

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

Affected Products

Product: Gentamicin Sulfate Ophthalmic Solution, USP, 0.3% (5 mL bottle)
Model:
NDC 17478-283-10
Recall #: D-0993-2019
Lot Numbers:
7B71A (Exp 01/2020)
Date Ranges: Expiration 01/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82200
Status: Resolved
Manufacturer: Akorn, Inc.
Sold By: pharmacies; hospitals
Manufactured In: United States
Units Affected: 51,456 bottles
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.