FDA Recall D-0445-2025

KVK Tech, Inc. · Newtown, PA

Class II Ongoing 370 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: Lot#: 18400A, Exp 7/31/2027

Quantity: 9107 bottles

Reason for recall

cGMP deviations

Recall record

Recall number: D-0445-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide
Recall initiated: 2025-05-09
Classified by FDA Center: 2025-05-21
FDA published: 2025-05-28
Recalling firm: KVK Tech, Inc.
Firm location: Newtown, PA

Drug identification

Brand name(s): INDOMETHACIN
Generic name(s): INDOMETHACIN
Manufacturer(s): KVK-Tech, Inc.
NDC(s): 10702-016
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls