The Recall Desk

Manufacturer

KVK-Tech, Inc.

15 recalls in our database name KVK-Tech, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
15
Critical
0
Severe
3
Most recent
2025-05-28

Of the 15 recalls from KVK-Tech, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (20%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–15 of 15

  • ModerateFDA (Drugs)·D-0446-2025·2025-05-28

    Phentermine Hydrochloride Capsules 30mg Recalled for cGMP Deviations

    KVK Tech, Inc. is recalling 9,680 bottles of Phentermine Hydrochloride Capsules 30mg nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall is voluntary and firm-initiated.

    Product
    PHENTERMINE HYDROCHLORIDE — PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0445-2025·2025-05-28

    Indomethacin Extended-Release Capsules Recalled for cGMP Deviations

    KVK Tech, Inc. is recalling Indomethacin Extended-Release Capsules USP, 75 mg (Lot #18400A) nationwide due to cGMP deviations. The recall affects approximately 9,107 bottles distributed nationwide.

    Product
    INDOMETHACIN — INDOMETHACIN (INDOMETHACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0049-2024·2023-10-25

    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.

    Product
    BETAXOLOL HYDROCHLORIDE — BETAXOLOL HYDROCHLORIDE (BETAXOLOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0772-2021·2021-09-01

    Atovaquone Oral Suspension Recalled for Temperature Abuse

    KVK-Tech, Inc. is recalling Atovaquone Oral Suspension due to temperature abuse that caused unusual grittiness in the product. The defect may affect the medication's quality and safety.

    Product
    ATOVAQUONE ORAL SUSPENSION — ATOVAQUONE ORAL SUSPENSION (ATOVAQUONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0386-2021·2021-05-26

    KVK-Tech Recalls Hydrocodone and Homatropine Tablets for Impurity Failures

    KVK-Tech, Inc. is recalling 17,096 bottles of Hydrocodone Bitartrate and Homatropine Methylibromide tablets due to failed impurities and degradation specifications.

    Product
    HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE — HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0224-2021·2021-01-20

    KVK-Tech Recalls Benzhydrocodone and Acetaminophen Tablets Due to Impurity

    KVK-Tech, Inc. is recalling 528 bottles of Benzhydrocodone and Acetaminophen Tablets because the N-Oxide impurity exceeded specifications during stability testing.

    Product
    Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 USA, NDC 10702-344-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0532-2020·2019-11-20

    KVK-Tech Recalls Hydrocodone and Homatropine Oral Solution Due to Foreign Particles

    KVK-Tech is recalling specific lots of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution because black particles were found during inspection.

    Product
    HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE — HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE (HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0142-2020·2019-10-23

    KVK-Tech Recalls Methylphenidate Hydrochloride Oral Solution Due to Foreign Particles

    KVK-Tech is recalling 384 bottles of Methylphenidate Hydrochloride Oral Solution because of the presence of fiber particles.

    Product
    Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free, Rx Only, Mfd by: KVK Tech, Inc., Newtown, PA 18940, NDC 10702-0163-50.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0340-2019·2018-12-26

    KVK-Tech Recalls Oxybutynin Chloride Tablets Due to Wrong Bar Code

    KVK-Tech, Inc. is recalling 156 bottles of Oxybutynin Chloride Tablets, 5 mg, because they bear the wrong bar code.

    Product
    OXYBUTYNIN CHLORIDE — OXYBUTYNIN CHLORIDE (OXYBUTYNIN CHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1083-2017·2017-08-23

    KVK-Tech Recalls Phentermine Hydrochloride Capsules Due to Impurity Failures

    KVK-Tech, Inc. is recalling specific lots of Phentermine Hydrochloride capsules because they failed impurity specifications during stability testing.

    Product
    PHENTERMINE HYDROCHLORIDE — PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1057-2016·2016-07-06

    KVK-Tech Recalls Benzphetamine Hydrochloride Tablets Due to Cosmetic Scuffing

    KVK-Tech, Inc. is recalling specific lots of Benzphetamine Hydrochloride Tablets due to cosmetic scuffing marks on the tablets.

    Product
    Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by: KVK-TECH, INC., Newtown, PA 18940, NDC 10702-0040-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1371-2015·2015-09-02

    KVK-Tech Recalls Phentermine Hydrochloride Capsules Due to Impurity Failures

    KVK-Tech is recalling specific lots of Phentermine Hydrochloride Capsules because they failed impurity specifications during stability testing.

    Product
    Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-count bottle (NDC 10702-0026-10; UPC 3 10702 02601 0); Rx only, Mfd. by KVK-TECH, Inc., Newtown, PA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1031-2014·2014-01-29

    KVK-Tech Recalls Hydroxyzine Hydrochloride Tablets Due to Unapproved Ingredient Source

    KVK-Tech, Inc. is recalling 249,096 bottles of Hydroxyzine Hydrochloride tablets because the active pharmaceutical ingredient was sourced from an unapproved supplier.

    Product
    HYDROXYZINE HYDROCHLORIDE — HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide