Recall archive / FDA company announcement

KVK Tech: Betaxolol Tablets, USP — FDA announcement Oct 3, 2023

Reported terminated

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Oct 3, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Betaxolol Tablets, USP
Reason: Potential Presence of Oxycodone HCl tablet
Classification: Not supplied
Recalling firm: KVK-Tech, Inc.
Quantity: Not supplied
Agency-reported status: Terminated in FDA listing
Source record identifier: f81f73f8b37316b1

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	FOR IMMEDIATE RELEASE – 09/29/2023 – Newtown, Pennsylvania, KVK-Tech, Inc. is voluntarily recalling one lot (Batch Number: 17853A; “the batch”) of Betaxolol Tablets, USP 10 mg, White, Round, film coated biconvex tablets, debossed “K” above bisect “13” on one side and plain on the other side” to the consumer level. The batch was distributed nationwide to wholesalers and retailers. The batch is being recalled as a precautionary measure due to a single Oxycodone HCl tablet 5 mg foreign tablet found on the packaging line during the line clearance after the subject batch was packaged. KVK has not received any reports of foreign tablet in any bottle of Betaxolol Tablets, USP 10 mg (Batch Number 17853A) at this time.; Betaxolol HCl Tablets are packaged in 50 CC White High-Density Polyethylene (HDPE) bottles, 100 Tablets and 10702-013-01. The affected Betaxolol Tablets, USP 10 mg lot 17853A has labeled expiration as June 2027. The product can be identified by using the images of tablets and labels provided below.; KVK notified its distributors and customers by a Recall Notification Letter via email and FedEx overnight mail on 09/26/2023 and is arranging for the return of all recalled product. KVK believes that a small number of bottles may have been distributed to retail pharmacies. Consumers that may have received Betaxolol Tablets, USP 10 mg (Batch Number: 17853A), should stop using and immediately return the product to KVK-Tech, Inc., 110 Terry Drive, Newtown, PA 18940. KVK will arrange to reimburse customers for their costs in purchasing the product.

Label field

Details supplied by the agency

Lot, code or applicability

FOR IMMEDIATE RELEASE – 09/29/2023 – Newtown, Pennsylvania, KVK-Tech, Inc. is voluntarily recalling one lot (Batch Number: 17853A; “the batch”) of Betaxolol Tablets, USP 10 mg, White, Round, film coated biconvex tablets, debossed “K” above bisect “13” on one side and plain on the other side” to the consumer level. The batch was distributed nationwide to wholesalers and retailers. The batch is being recalled as a precautionary measure due to a single Oxycodone HCl tablet 5 mg foreign tablet found on the packaging line during the line clearance after the subject batch was packaged. KVK has not received any reports of foreign tablet in any bottle of Betaxolol Tablets, USP 10 mg (Batch Number 17853A) at this time.; Betaxolol HCl Tablets are packaged in 50 CC White High-Density Polyethylene (HDPE) bottles, 100 Tablets and 10702-013-01. The affected Betaxolol Tablets, USP 10 mg lot 17853A has labeled expiration as June 2027. The product can be identified by using the images of tablets and labels provided below.; KVK notified its distributors and customers by a Recall Notification Letter via email and FedEx overnight mail on 09/26/2023 and is arranging for the return of all recalled product. KVK believes that a small number of bottles may have been distributed to retail pharmacies. Consumers that may have received Betaxolol Tablets, USP 10 mg (Batch Number: 17853A), should stop using and immediately return the product to KVK-Tech, Inc., 110 Terry Drive, Newtown, PA 18940. KVK will arrange to reimburse customers for their costs in purchasing the product.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

KVK notified its distributors and customers by a Recall Notification Letter via email and FedEx overnight mail on 09/26/2023 and is arranging for the return of all recalled product. KVK believes that a small number of bottles may have been distributed to retail pharmacies. Consumers that may have received Betaxolol Tablets, USP 10 mg (Batch Number: 17853A), should stop using and immediately return the product to KVK-Tech, Inc., 110 Terry Drive, Newtown, PA 18940. KVK will arrange to reimburse customers for their costs in purchasing the product.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Pennsylvania

Dates in the source

Fda listing date: Oct 3, 2023
Company announcement date: Sep 29, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.