CLASS I Drug recall · Reported 25 Oct 2023 · FDA Enforcement Report
Betaxolol Tablets, USP 10 mg recalled by KVK-Tech
Kvk-Tech is recalling Betaxolol Tablets, USP 10 mg, distributed nationwide in the US. The recall was initiated on 20 Sep 2023 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0049-2024
- FDA event ID
- 93101
- Recalling firm
- Kvk-Tech, Newtown, PA
- Manufacturer
- KVK-TECH, INC.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 20 Sep 2023
- FDA classified
- 18 Oct 2023
- Reported
- 25 Oct 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 20 Sep 2023 | Recall initiated by company | |
| 18 Oct 2023 | Classified by FDA | +28 days |
| 25 Oct 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Product as listed by the FDA
Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10702-013-01.
Where it was distributed
Nationwide in the USA and PR
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Which lots are affected?
Lot # 17853A, Exp. 06/30/2027
Where was it sold?
Nationwide in the USA and PR
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Kvk-Tech
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|---|---|---|---|---|---|
| Drug | CLASS II | Phentermine Hydrochloride Capsules, USP 30mg recalled by KVK TechPhentermine Hydrochloride | KVK Tech | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Indomethacin Extended-Release Capsules USP, 75 mg recalled by KVK TechIndomethacin | KVK Tech | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Atovaquone Oral Suspension, USP, 750 mg recalled by KVK-TechAtovaquone Oral Suspension | Kvk-Tech | Temperature Abuse | Nationwide |
| Drug | CLASS III | Hydrocodone Bitartrate and Homatropine Methlybromide recalledHydrocodone Bitartrate And Homatropine Methylbromide | Kvk-Tech | Potency & Assay | Nationwide |
| Drug | CLASS III | Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg recalled | Kvk-Tech | Potency & Assay | Nationwide |
Other Betaxolol recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Betaxolol Ophthalmic Solution recalled by Akorn | Akorn | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Betaxolol Ophthalmic Solution recalled by Akorn | Akorn | Sterility | Nationwide |