Medications & Supplements/Prescription Drugs

AVKARE Inc.: Dutasteride Capsules Recalled Due to Failed Impurity Specifications

Agency Publication Date: January 10, 2020

Summary

AvKARE Inc. is voluntarily recalling approximately 3,989 cartons of Dutasteride (0.5 mg) capsules because the medication failed testing for impurities and degradation. Testing showed high results for related compounds, which means the drug may contain more chemical breakdown products than is safely allowed. This recall affects 30-count unit dose cartons sold nationwide, and consumers should immediately verify if they have the affected lot numbers.

Risk

The presence of high levels of impurities or degradation compounds can potentially impact the safety and effectiveness of the medication. While specific injuries have not been reported, these chemical specifications ensure the drug remains stable and safe for patient use throughout its shelf life.

What You Should Do

Check your medication packaging for Dutasteride Capsules, 0.5 mg, specifically the 30-capsule (6 x 5) unit dose cartons with NDC 50268-282-13.
Identify if your product matches one of the following three affected lot numbers and expiration dates: Lot 25246 (Exp. 02/2021), Lot 24532 (Exp. 10/2020), or Lot 23647 (Exp. 06/2020).
Contact your healthcare provider or pharmacist immediately to discuss continuing your treatment and to obtain a replacement prescription if necessary.
Return any unused capsules from the affected lots to the pharmacy or place of purchase for a refund and to ensure the product is properly handled.
Contact AvKARE Inc. for further instructions regarding the return process at their Pulaski, TN location or through their customer service channels.
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

Full 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: Dutasteride Capsules, 0.5 mg (30 Capsules per carton)

Model:

NDC 50268-282-13

D-0661-2020

Lot Numbers:

25246 (Exp. 02/2021)

24532 (Exp. 10/2020)

23647 (Exp. 06/2020)

Date Ranges: Expiration 02/2021, Expiration 10/2020, Expiration 06/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84677

Status: Resolved

Manufacturer: AVKARE Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 3,989 cartons

Distributed To: Nationwide

Agency Last Updated: January 13, 2020

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 · 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.

Summary

What You Should Do

Check your medication packaging for Dutasteride Capsules, 0.5 mg, specifically the 30-capsule (6 x 5) unit dose cartons with NDC 50268-282-13.

Identify if your product matches one of the following three affected lot numbers and expiration dates: Lot 25246 (Exp. 02/2021), Lot 24532 (Exp. 10/2020), or Lot 23647 (Exp. 06/2020).

Contact your healthcare provider or pharmacist immediately to discuss continuing your treatment and to obtain a replacement prescription if necessary.

Return any unused capsules from the affected lots to the pharmacy or place of purchase for a refund and to ensure the product is properly handled.

Contact AvKARE Inc. for further instructions regarding the return process at their Pulaski, TN location or through their customer service channels.

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.