Ata International Blue Fusion Capsules Recall: FDA Class I

Why it was recalled

Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein.

Product description

Blue Fusion Capsules, 1- count blister pack, Distributed by: DNS Distribution 5225 Canyon Crest Dr. Ste 71-640, Riverside, CA 92507, UPC 7 48252 66460 0

Lot numbers, UPCs & expiration codes

All lots

Where it was sold

Nationwide within the United States

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1085-2019
Classification: Class I
Status: Terminated
Recall initiated: Mar 14, 2019
FDA report date: Apr 3, 2019
Quantity: Unknown
Recall type: Voluntary: Firm initiated
Recalling firm: Ata International Inc

Original FDA data

Every field from FDA enforcement report D-1085-2019, exactly as published.

Show all FDA fields

City: Orange
State: CA
Status: Terminated
Country: United States
Event ID: 82419
Address: 8241 E Loftwood Ln
Code information: All lots
Postal code: 92867-6488
Report date: Apr 3, 2019
Product type: Drugs
Recall number: D-1085-2019
Classification: Class I
Recalling firm: Ata International Inc
Product quantity: Unknown
Termination date: Feb 27, 2023
Reason for recall: Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Blue Fusion Capsules, 1- count blister pack, Distributed by: DNS Distribution 5225 Canyon Crest Dr. Ste 71-640, Riverside, CA 92507, UPC 7 48252 66460 0
Distribution pattern: Nationwide within the United States
Recall initiation date: Mar 14, 2019
Initial firm notification: E-Mail
Center classification date: Apr 9, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1085-2019, published Apr 3, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Ata International Blue Fusion Capsules Recall

Summary