The Recall Desk
SevereFDA (Drugs)·D-0049-2024·Announced 2023-10-25

Betaxolol Hydrochloride tablets recalled due to oxycodone contamination

KVK-Tech's Betaxolol Hydrochloride tablets (10 mg, lot 17853A) are being recalled nationwide due to potential contamination with oxycodone tablets. Patients should stop using affected bottles immediately and contact their healthcare provider.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall. Although no illnesses or deaths have been reported, the potential presence of a different medication in labeled product containers poses serious health risks. FDA Class I classification mandates a minimum severity score of 4.

Plain-English summary

KVK-Tech, Inc. is recalling Betaxolol Hydrochloride tablets, USP 10 mg (100-count bottles), due to the potential presence of oxycodone HCl tablets mixed into the bottles. The recall affects lot number 17853A with an expiration date of 06/30/2027.

The affected product has been distributed nationwide in the United States and Puerto Rico, comprising 1,488 bottles with NDC# 10702-013-01.

The presence of oxycodone tablets in bottles of Betaxolol Hydrochloride could result in patients receiving an unintended medication, posing serious health risks.

Patients with affected bottles should stop using the medication immediately and contact their healthcare provider or pharmacist for guidance.

The recalled product

Product
BETAXOLOL HYDROCHLORIDE (BETAXOLOL HYDROCHLORIDE)
Brand
BETAXOLOL HYDROCHLORIDE
Manufacturer
KVK-Tech, Inc.
Category
Drug
Hazard
  • product-contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # 17853A
  • Exp. 06/30/2027

Distribution

Distributed nationwide across the United States.