The Recall Desk
ModerateFDA (Drugs)·D-0445-2025·Announced 2025-05-28

Indomethacin Extended-Release Capsules Voluntarily Recalled for Manufacturing Deviations

KVK Tech, Inc. is voluntarily recalling Indomethacin Extended-Release Capsules USP, 75 mg, due to manufacturing process deviations. The recall affects 9,107 bottles distributed nationwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing process deviation (cGMP non-compliance) without specification of a particular product defect. Per the severity rubric, voluntary precautionary recalls with no reported harm warrant a Moderate (2) score.

Plain-English summary

KVK Tech, Inc. is voluntarily recalling Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottles, due to deviations from current good manufacturing practice (cGMP). The recall was initiated on May 9, 2025, and affects 9,107 bottles distributed nationwide.

Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) used to reduce inflammation and manage pain. The specific manufacturing deviations have not been detailed in the FDA recall notice.

Patients currently taking recalled indomethacin should consult their healthcare provider or pharmacist about obtaining a replacement supply. The recall status is ongoing.

The recalled product

Product
INDOMETHACIN (INDOMETHACIN)
Brand
INDOMETHACIN
Manufacturer
KVK Tech, Inc.
Category
Drug
Hazard
  • manufacturing-defect

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#: 18400A
  • Exp 7/31/2027

UPCs (2)

  • 0310702016101
  • 0310702016033

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · INDOMETHACIN

Same category