The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0445-2025·Announced 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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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: This is an FDA Class II recall for cGMP deviations, a manufacturing process deviation. The source text does not report any illnesses, injuries, or confirmed adverse health consequences, making this a precautionary/compliance-based recall typical of Class II classifications without reported harm.

Plain-English summary

KVK Tech, Inc. is recalling Indomethacin Extended-Release Capsules USP, 75 mg, in 100-count bottles (NDC 10702-016-01) due to cGMP (current Good Manufacturing Practices) deviations. The affected lot is #18400A with an expiration date of 7/31/2027. Approximately 9,107 bottles were distributed nationwide.

This is a voluntary recall initiated by the manufacturer on May 9, 2025, following notification to the FDA. The FDA classified this as a Class II recall.

Patients taking this medication should not stop taking their indomethacin without consulting their healthcare provider. Consumers with bottles from the affected lot should contact their pharmacist or healthcare provider for further guidance or replacement product.

The recalled product

Product
INDOMETHACIN (INDOMETHACIN)
Brand
INDOMETHACIN
Manufacturer
KVK Tech, Inc.
Category
Drug — Prescription / Non-Steroidal Anti-Inflammatory
Hazard
Affected units
9,107

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.

Part of a larger recall action

This product is one of 2 recalled by KVK Tech, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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