FDA Drugs recall ·
Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle… recall
- Recall number
- D-0445-2025
- Date
- (initiated May 9, 2025)
- Company / brand
- KVK Tech, Inc.
110 Terry Dr, Newtown, PA, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 9107 bottles
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
cGMP deviations
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot#: 18400A, Exp 7/31/2027
Distribution
Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0445-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.