Ajanta Pharma Recalls Fenofibrate 200mg Capsules Over CGMP Violations

Ajanta Pharma USA Inc. has voluntarily initiated a recall of its ‘Fenofibrate Capsules, USP 200 mg’ after the U.S. Food and Drug Administration identified current Good Manufacturing Practice (CGMP) deviations at the manufacturing facility. A total of 3,648 bottles are affected, distributed across the United States under Lot # PA02216 with an expiration date of December 2029.

What Products Are Being Recalled?

The recalled product is:

• Product Name: Fenofibrate Capsules, USP 200 mg, Rx only
• Manufacturer: Ajanta Pharma Limited, India
• Marketed By: Ajanta Pharma USA Inc., Bridgewater, NJ 08807
• NDC: 27241-120-04
• Lot Number: PA02216
• Expiration Date: 12/2029
• Package Size: 100 Capsules per bottle
• Units Affected: 3,648 bottles
• Recall Number: D-0611-2026

Why Was This Recall Issued?

The recall was triggered due to CGMP deviations identified in the manufacturing process. CGMP regulations, enforced by the FDA, are a set of standards that pharmaceutical manufacturers must follow to ensure that drug products are consistently produced and controlled according to quality standards. Deviations from these standards can result in products that do not meet their intended specifications for safety, identity, strength, quality, and purity.

While the FDA has classified this recall as Class II, indicating that the probability of serious adverse health consequences is remote, the violations nonetheless present a potential risk that warrants consumer attention. The recall was voluntarily initiated by Ajanta Pharma USA Inc. on May 28, 2026, and was classified by the FDA center on June 22, 2026.

Who Is Affected?

This recall affects patients and healthcare providers across the United States who may have received or dispensed Fenofibrate Capsules USP 200 mg from Lot # PA02216. The distribution was nationwide, meaning affected bottles may be found in retail pharmacies, hospital pharmacies, and other healthcare facilities throughout the country.

Fenofibrate is a prescription medication commonly used to lower elevated levels of cholesterol and triglycerides in the blood. Patients who rely on this medication to manage their lipid levels should check whether their prescription corresponds to the recalled lot number.

What Should You Do?

• Check your prescription bottle for the lot number ‘PA02216’ printed on the label.
• If your bottle matches the recalled lot, stop using the product immediately and contact your pharmacist or healthcare provider for guidance.
• Do not dispose of the product before consulting your pharmacist, as they may require the bottle to be returned for proper handling.
• Healthcare professionals and distributors should quarantine any remaining inventory from Lot # PA02216 and contact Ajanta Pharma USA Inc. for return and replacement instructions.
• Continue any necessary lipid-lowering therapy only after consulting with your doctor, who may prescribe an alternative medication if needed.
• Report any adverse reactions or quality complaints related to this product to the FDA MedWatch program at 1-800-FDA-1088 or online at www.fda.gov/medwatch.

Official Statement

No press release has been issued by Ajanta Pharma USA Inc. in connection with this recall. The recall is listed as ongoing, with no termination date announced as of the time of publication. The FDA has assigned this recall Event ID 99130 and classified it as a Class II recall under Recall Number D-0611-2026.

Consumers and healthcare professionals seeking further information may contact Ajanta Pharma USA Inc. at their registered address: 400 Crossing Blvd, Ste 102, Bridgewater, NJ 08807-2863, United States. Updates will be provided as the recall investigation progresses.