Duloxetine Delayed-Release Capsules Recall Issued

Source: FDA · United States

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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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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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 ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Ajanta Pharma Ltd. is recalling Duloxetine Delayed-Release Capsules, 20 mg, due to N-nitroso-Duloxetine impurity levels exceeding FDA limits.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.