Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Aja
Summary
The FDA issued a Class II for Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta by Ajanta Pharma USA Inc. Reason: CGMP Deviations.
Details
Source
Drug Recall
External ID
D-0611-2026
Action Date
2026-07-01
Status
Ongoing
Category
drug
Product Description
Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120-04.
Lot/Code Info: Lot # PA02216; Exp. 12/2029
Quantity Affected: 3648 bottles
Reason for Recall
CGMP Deviations
Distribution
U.S. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-28
Company
Bridgewater, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 49 drug recalls issued in the same week, part of 60 drug-related FDA actions this month.
Ajanta Pharma USA Inc has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ajanta Pharma USA Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ajanta Pharma USA Inc have FDA actions?
Ajanta Pharma USA Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0611-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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