Indomethacin Extended-Release Capsules USP — Class II drug recall D-0445-2025
Ongoing recall by KVK Tech, Inc., reported 2025-05-28, distributed nationwide. cGMP deviations
| Recall number | D-0445-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | KVK Tech, Inc., Newtown, PA, United States |
| Recall initiated | 2025-05-09 |
| Classified | 2025-05-21 |
| Reported by FDA | 2025-05-28 |
| Distributed | Nationwide (US) |
| Quantity | 9,107 bottles |
| Reason classes | cgmp |
| NDC | 10702-0016, 10702-0016-01, 10702-0016-03, 10702-0016-06, 10702-0016-09, 10702-0016-10, 10702-0016-50 |
| Lot numbers | 18400A |
| Expiration dates | 2027-07-31 |
Product
Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01.
Reason for recall
cGMP deviations
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0445-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.