Fenofibrate Capsules Recall Due to CGMP Deviations
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Ajanta Pharma USA Inc. is recalling 3,648 bottles of Fenofibrate Capsules, USP 200 mg nationwide due to CGMP deviations.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 3, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened Ajanta Pharma USA Inc. initiated a voluntary recall of Fenofibrate Capsules due to CGMP deviations. The recall is classified as Class II by the FDA and is ongoing.
Which Products Are Affected Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules (NDC 27241-120-04), manufactured by Ajanta Pharma Limited, India and marketed by Ajanta Pharma USA Inc., Bridgewater, NJ. Affected lot is PA02216 with expiration 12/2029. A total of 3,648 bottles are involved in the U.S. Nationwide distribution.
What You Should Do Consumers should contact Ajanta Pharma USA Inc. for return or refund instructions. The recalling firm is located at 400 Crossing Blvd Ste 102, Bridgewater, NJ 08807.
Why This Matters The recall affects prescription medication distributed across the United States, highlighting ongoing compliance issues with manufacturing standards.
Source FDA recall D-0611-2026, report date 20260701.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (936 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.