Medications & Supplements/Prescription Drugs

Upsher Smith Laboratories, Inc.: Bexarotene Capsules Recalled for Failed Dissolution Specifications

Agency Publication Date: August 19, 2019

Summary

Upsher Smith Laboratories, Inc. is recalling 166 bottles of Bexarotene (75 mg) capsules, a prescription medication used to treat certain skin effects of T-cell lymphoma. The recall was initiated because the medication failed dissolution specifications, meaning the drug may not dissolve properly in the body as intended. This defect could potentially affect how the medication is absorbed and its overall effectiveness for patients. These specific bottles were distributed to Kentucky, Ohio, New Jersey, and Louisiana.

Risk

If the capsules do not dissolve correctly, the patient may not receive the intended dose of the medication, which could lead to a lack of therapeutic effect or inconsistent treatment for their condition.

What You Should Do

Identify if you have the affected medication by checking the label for Bexarotene Capsules, 75 mg, in 100-count bottles with NDC 0832-0285-00.
Check the bottle for lot number A2610 with an expiration date of 3/2020.
Contact your healthcare provider or pharmacist immediately for guidance if you find you have medication from this lot.
Return any unused product from lot A2610 to your pharmacy for a refund.
Contact Upsher Smith Laboratories, Inc. at their Maple Grove, Minnesota headquarters if you have further questions regarding this recall.
For additional information 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 refund

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

Affected Products

Product: Bexarotene Capsules, 75 mg (100 capsules per bottle)

Model:

NDC: 0832-0285-00

Recall #: D-1836-2019

Lot Numbers:

A2610 (exp 3/2020)

Date Ranges: exp 3/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83501

Status: Resolved

Manufacturer: Upsher Smith Laboratories, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 166 bottles

Distributed To: Kentucky, Ohio, New Jersey, Louisiana

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

Identify if you have the affected medication by checking the label for Bexarotene Capsules, 75 mg, in 100-count bottles with NDC 0832-0285-00.

Check the bottle for lot number A2610 with an expiration date of 3/2020.

Contact your healthcare provider or pharmacist immediately for guidance if you find you have medication from this lot.

Return any unused product from lot A2610 to your pharmacy for a refund.

Contact Upsher Smith Laboratories, Inc. at their Maple Grove, Minnesota headquarters if you have further questions regarding this recall.

For additional information 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.