KVK Tech recalls Indomethacin Extended-Release Capsules due to manufacturing deviations
KVK Tech recalls 75mg Indomethacin Extended-Release Capsules (NDC 10702-016-01) made in USA with cGMP deviations. Consumers should contact the manufacturer for details.
Recall notice
cGMP deviations
Contact the company
What happened, in plain English
KVK Tech is recalling 75mg Indomethacin Extended-Release Capsules (100-count bottles) due to manufacturing deviations. This recall affects prescription-only medication made in the USA. The product may pose safety risks if the manufacturing issues lead to improper drug release. Read more at govinfonow.com/recall/32083-kvk-tech-recalls-indomethacin-extended-release-capsules-due-to-manufacturing.
Source Summary by GovInfoNow · govinfonow.com/recall/32083-kvk-tech-recalls-indomethacin-extended-release-capsules-due-to-manufacturing · Updated August 17, 2026 · FDA enforcement record: FDA #D-0445-2025
Cite this page
“KVK Tech recalls Indomethacin Extended-Release Capsules due to manufacturing deviations.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32083-kvk-tech-recalls-indomethacin-extended-release-capsules-due-to-manufacturing. Based on FDA recall #D-0445-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0445-2025%22&limit=1).
Why it’s dangerous
The recall is due to cGMP (current Good Manufacturing Practice) deviations, which are regulatory standards for drug production. These deviations could potentially affect the drug's release mechanism or safety profile, though the specific risk is not detailed in the recall notice.
Who’s affected
Prescription holders of this medication are affected. Patients using the recalled product for conditions like arthritis or pain may be at risk if the manufacturing deviations impact drug effectiveness.
How to tell if you have this one
Check for the product name 'Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle' with NDC code 10702-016-01. The product was manufactured by KVK Tech in Newtown, PA, USA, with lot number 18400A and expiration date 7/31/2027.
- Brand
KVK Tech- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0445-2025 | 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.; Lot#: 18400A, Exp 7/31/2027 | 9107 bottles | 10702-016-03, 10702-016-06, 10702-016-09, 10702-016-01, 10702-016-50, 10702-016-10 |
| D-0446-2025 | Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-028-01.; Lot#: 18350A, 18351A, Exp 6/30/2027 | 9680 bottles | 10702-026-03, 10702-026-01, 10702-026-10, 10702-027-03, 10702-027-01, 10702-027-10, 10702-028-03, 10702-028-01, 10702-028-10 |
What to do — step by step
Contact Manufacturer
Reach out to KVK Tech, Inc. for specific instructions on handling the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 19 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the expiration date of the recalled product?
The product expires on July 31, 2027, as indicated in the recall notice.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0445-2025 (May 9, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0445-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.