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.
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: 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.
- Hazard
- cgmp-deviation
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.
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