Duloxetine Delayed-Release Capsules Recall
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Ajanta Pharma Ltd. is recalling Duloxetine Delayed-Release Capsules due to CGMP deviations involving N-nitroso-Duloxetine impurity above the FDA limit.
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. The presence of N-nitroso-Duloxetine impurity was identified above the FDA recommended limit of 0.83 ppm at the 12-month and 18-month long-term stability intervals.
Which Products Are Affected
Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, marketed by Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India. Affected products include:
- 90 Capsules, NDC 27241-098-09, Lot PA10774, Exp. May 2026
- 30 capsules, NDC 27241-098-03, Lots PA10794, PA12174, Exp. Jun 2026
- 1000 Capsules, NDC 27241-098-10, Lot PA10804, Exp. Jun-26 A total of 312,894 packs are affected. Distribution was nationwide within the U.S.
What You Should Do
Consumers should contact the recalling firm for return or refund instructions. The recall was initiated via letter on a voluntary, firm-initiated basis.
Why This Matters
The recall addresses impurity levels exceeding FDA limits in a widely distributed prescription drug.
Source
FDA recall number D-0514-2026
Original source: FDA Official Notice ↗
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