Medications & Supplements/Prescription Drugs

Indomethacin and Phentermine Capsules Recalled for cGMP Deviations

Agency Publication Date: May 21, 2025

Summary

KVK Tech, Inc. is voluntarily recalling 18,787 bottles of Indomethacin Extended-Release Capsules (75 mg) and Phentermine Hydrochloride Capsules (30 mg). The recall was initiated due to deviations from Current Good Manufacturing Practice (cGMP) requirements, which ensure medications meet strict safety and quality standards. This recall includes 9,107 bottles of Indomethacin and 9,680 bottles of Phentermine dispensed in 100-count bottles.

Risk

Manufacturing practice deviations can result in medications that are substandard in quality, which may potentially impact their safety or how well the drugs work. No specific injuries or adverse health effects have been reported in the recall data.

What You Should Do

This recall affects 100-count bottles of Indomethacin Extended-Release Capsules (75 mg) and Phentermine Hydrochloride Capsules (30 mg) manufactured by KVK Tech, Inc. and distributed nationwide.
Identify the affected products by checking the label for specific codes: Indomethacin (NDC 10702-016-01) with lot number 18400A (Exp 7/31/2027), and Phentermine (NDC 10702-028-01) with lot numbers 18350A or 18351A (Exp 6/30/2027).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Indomethacin Extended-Release Capsules USP (100-count bottle)

Variants: 75 mg, Extended-Release, Capsule

Lot Numbers:

18400A (Exp 7/31/2027)

NDC:

10702-016-01

Quantity: 9107 bottles

Product: Phentermine Hydrochloride Capsules, USP (100-count bottle)

Variants: 30mg, Capsule

Lot Numbers:

18350A (Exp 6/30/2027)

18351A (Exp 6/30/2027)

NDC:

10702-028-01

Quantity: 9680 bottles

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96847

Status: Active

Manufacturer: KVK Tech, Inc.

Sold By: Retail Pharmacies

Manufactured In: United States

Units Affected: 2 products (9107 bottles; 9680 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects 100-count bottles of Indomethacin Extended-Release Capsules (75 mg) and Phentermine Hydrochloride Capsules (30 mg) manufactured by KVK Tech, Inc. and distributed nationwide.

Identify the affected products by checking the label for specific codes: Indomethacin (NDC 10702-016-01) with lot number 18400A (Exp 7/31/2027), and Phentermine (NDC 10702-028-01) with lot numbers 18350A or 18351A (Exp 6/30/2027).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Indomethacin Extended-Release Capsules USP (100-count bottle)

Variants: 75 mg, Extended-Release, Capsule

Lot Numbers:

18400A (Exp 7/31/2027)

NDC:

10702-016-01

Quantity: 9107 bottles

Product: Phentermine Hydrochloride Capsules, USP (100-count bottle)

Variants: 30mg, Capsule

Lot Numbers:

18350A (Exp 6/30/2027)

18351A (Exp 6/30/2027)

NDC:

10702-028-01

Quantity: 9680 bottles