FDA Drug recall D-0445-2025
Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd
- FDA Drug
- Class II
- ongoing
- Published 2025-05-28
On 2025-05-28 the FDA classified a Class II recall of Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd by Kvk Tech, citing cGMP deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0445-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-09 |
| Published | 2025-05-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Kvk Tech |
| Distribution | US |
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
cGMP deviations
Identifiers
| ndc | 10702-016-03 |
|---|---|
| ndc | 10702-016-06 |
| ndc | 10702-016-09 |
| ndc | 10702-016-01 |
| ndc | 10702-016-50 |
| ndc | 10702-016-10 |
| code_info | Lot#: 18400A, Exp 7/31/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0445-2025%22
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