Sun Pharmaceutical Recalls Perampanel 6mg Tablets
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Sun Pharmaceutical Industries Inc. is recalling 3,456 bottles of Perampanel CIII 6mg tablets nationwide due to a label mix-up with 10mg tablets.
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
Sun Pharmaceutical Industries Inc. initiated a voluntary recall of Perampanel CIII Tablets after a 10mg tablet was found in a bottle labeled as 6mg.
Which Products Are Affected
Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, NDC 51672-4206-6, Lot AE01763, Expires 9/30/2027. Manufactured by Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel, distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ. A total of 3,456 30-count bottles are affected. Distributed nationwide in the USA. Recall number D-0628-2026. Classification: Class II.
What You Should Do
The recall was initiated by letter. Consumers should contact Sun Pharmaceutical Industries Inc. regarding the affected product.
Why This Matters
The labeling mix-up affects a prescription drug distributed across the United States.
Source
FDA recall D-0628-2026. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
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 (933 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.