Ajanta Pharma Recalls Duloxetine Capsules
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Ajanta Pharma Ltd. is recalling Duloxetine Delayed-Release Capsules, 60 mg due to N-nitroso-Duloxetine impurity levels exceeding FDA limits.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 24, 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.
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What Happened Ajanta Pharma Ltd. initiated a voluntary recall due to CGMP deviations involving the presence of N-nitroso-Duloxetine impurity above the FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Which Products Are Affected Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, marketed by Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03. Affected lot is PA07434 with expiration May 2026. A total of 77,376 packs are involved. Distribution was nationwide within the U.S.
What You Should Do This is a Class II recall initiated by the firm via letter.
Why This Matters The recall addresses impurity levels above FDA limits in a prescription drug distributed across the United States.
Source FDA recall number D-0515-2026, report date 20260513.
Original source: FDA Official Notice ↗
Related FDA Recalls
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Similar body length
Nearest notices by article body length (869 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 24, 2026.
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