Medications & Supplements/Prescription Drugs

AVKARE Inc.: Sildenafil and Trazodone Tablets Recalled Due to Product Mix-Up

Agency Publication Date: December 16, 2020

Summary

AVKARE Inc. is recalling 53,083 bottles of Sildenafil (generic Viagra) 100 mg tablets and Trazodone Hydrochloride 100 mg tablets. These two distinct medications were inadvertently packaged together at a third-party facility, meaning bottles labeled as one drug may contain the other. Consumers should immediately check their medication bottles, as taking the incorrect drug can lead to serious health complications. If you have these products, contact your healthcare provider or pharmacist immediately to discuss next steps and how to obtain the correct medication.

Risk

Taking sildenafil when not intended can cause dangerously low blood pressure, especially if taken with nitrates (often used for heart conditions), while unintentionally taking trazodone can cause extreme sedation, dizziness, and constipation. These mix-ups can lead to serious adverse health consequences or accidental injury.

What You Should Do

Check your medication bottles for Sildenafil Tablets USP 100 mg (100-count bottle) with NDC 42291-748-01, Lot 36884, and an expiration date of 03/2022.
Check your medication bottles for Trazodone Hydrochloride Tablets USP 100 mg (1000-count bottle) with NDC 42291-834-10, Lot 36783, and an expiration date of 06/2022.
Contact your healthcare provider or pharmacist for guidance if you believe you have taken the incorrect medication or to confirm your supply is safe.
Return any unused product from the affected lots to your pharmacy for a refund and to ensure you receive the correct medication.
Contact AVKARE Inc. at their facility in Pulaski, Tennessee, for further instructions regarding this recall.
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

Pharmacy return for refund

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

Affected Products

Product: Sildenafil Tablets USP 100 mg (100-count Bottle)

Model:

NDC 42291-748-01

Lot Numbers:

36884 (Exp. 03/2022)

Date Ranges: 03/2022

Product: TraZODONE Hydrochloride Tablets USP 100 mg (1000-count Bottle)

Model:

NDC 42291-834-10

Lot Numbers:

36783 (Exp. 06/2022)

Date Ranges: 06/2022

Product Images

Product labeling AvKare TraZODONE Hydrochloride Tablets USP 100 mg, 1000 Tablets Rx Only

Product image top and bottom of tablets AvKare TraZODONE Hydrochloride Tablets USP 100 mg

Product labeling AvKare Sildenafil Tablets USP 100 mg, 100 Tablets Rx Only

Product image top and bottom of tablets AvKare TraZODONE Sildenafil USP 100 mg

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86940

Status: Resolved

Manufacturer: AVKARE Inc.

Sold By: pharmacies; healthcare providers

Manufactured In: United States

Units Affected: 2 products (38715 bottles; 14368 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 · FDA Press Release · 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

Risk

What You Should Do

Check your medication bottles for Sildenafil Tablets USP 100 mg (100-count bottle) with NDC 42291-748-01, Lot 36884, and an expiration date of 03/2022.

Check your medication bottles for Trazodone Hydrochloride Tablets USP 100 mg (1000-count bottle) with NDC 42291-834-10, Lot 36783, and an expiration date of 06/2022.

Contact your healthcare provider or pharmacist for guidance if you believe you have taken the incorrect medication or to confirm your supply is safe.

Return any unused product from the affected lots to your pharmacy for a refund and to ensure you receive the correct medication.

Contact AVKARE Inc. at their facility in Pulaski, Tennessee, for further instructions regarding this recall.

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.