Duloxetine Delayed-Release Capsules Recall Issued
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Ajanta Pharma Ltd. is recalling Duloxetine Delayed-Release Capsules, 20 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 of Duloxetine Delayed-Release Capsules 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, 20 mg, Rx Only, 60 capsules, NDC 27241-097-06, Lot#: PA10734, Exp. Jun 2026. Marketed by Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India. A total of 117,168 packs are affected. Distribution was nationwide within the U.S.
What You Should Do Consumers should contact their healthcare provider regarding the recalled product.
Why This Matters The recall addresses impurity levels above FDA limits in a prescription medication distributed across the United States.
Source FDA recall D-0516-2026
Original source: FDA Official Notice ↗
Related FDA Recalls
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Similar body length
Nearest notices by article body length (888 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 24, 2026.
Frequently Asked Questions
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