Duloxetine Delayed-Release Capsules Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
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 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
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 ↗
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 (1,090 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 24, 2026.
Frequently Asked Questions
Common questions about this FDA recall.