Medications & Supplements/Prescription Drugs

AuroMedics Pharma LLC: Gabapentin Capsules Recalled Due to Presence of Foreign Medication

Agency Publication Date: December 13, 2019

Summary

AuroMedics Pharma LLC is recalling one lot of Gabapentin (gabapentin) Capsules, USP 100 mg, packaged in 1000-count bottles. The recall was initiated because a single tablet of a different medication, Losartan Potassium and Hydrochlorothiazide (HCTZ), was found inside a bottle of Gabapentin. This cross-contamination means a patient could accidentally take a blood pressure medication instead of their intended dose of Gabapentin, which is typically used for seizures or nerve pain. Consumers should check their prescription bottles immediately to see if their medication is part of the affected lot.

Risk

Taking an unintended dose of Losartan/HCTZ can cause a sudden and dangerous drop in blood pressure, kidney complications, or electrolyte imbalances. These risks are significantly higher for pregnant women or individuals already taking other blood pressure medications.

What You Should Do

Check your prescription bottle label for Gabapentin Capsules, USP 100 mg, with NDC 65682-198-99.
Verify the lot number and expiration date on the bottle: check for Lot number 19819029A3 with an expiration date of 08/2021.
If you identify that your bottle is from the affected lot, look closely at the capsules to ensure they are consistent and do not contain a foreign tablet.
Contact your healthcare provider or pharmacist immediately to report the issue, discuss your ongoing treatment, and arrange for a safe replacement medication.
Return any unused product from this lot to the pharmacy where you purchased it for a refund.
Contact AuroMedics Pharma LLC at their East Windsor, New Jersey office for further instructions regarding this recall.
For additional questions or to report a complaint, 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

Return to pharmacy for refund and consult healthcare provider.

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

Affected Products

Product: Gabapentin Capsules, USP 100 mg (1000 count bottle)

Model:

NDC 65682-198-99

Lot Numbers:

19819029A3 (Exp. 08/2021)

Date Ranges: Expiration Date: 08/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84308

Status: Resolved

Manufacturer: AuroMedics Pharma LLC

Sold By: pharmacies nationwide

Manufactured In: United States

Distributed To: Nationwide

Agency Last Updated: January 8, 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 prescription bottle label for Gabapentin Capsules, USP 100 mg, with NDC 65682-198-99.

Verify the lot number and expiration date on the bottle: check for Lot number 19819029A3 with an expiration date of 08/2021.

If you identify that your bottle is from the affected lot, look closely at the capsules to ensure they are consistent and do not contain a foreign tablet.

Contact your healthcare provider or pharmacist immediately to report the issue, discuss your ongoing treatment, and arrange for a safe replacement medication.

Return any unused product from this lot to the pharmacy where you purchased it for a refund.

Contact AuroMedics Pharma LLC at their East Windsor, New Jersey office for further instructions regarding this recall.

For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.