Duloxetine DR Capsules Recall Due to Nitrosamine Impurity
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Asclemed USA Inc. is recalling 50 bottles of Duloxetine DR Capsules, 30 mg due to CGMP deviations and N-nitroso-duloxetine impurity above FDA limits.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 9, 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
Asclemed USA Inc. initiated a voluntary recall due to CGMP deviations and the presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Which Products Are Affected
Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, relabeled by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, marketed by Ajanta Pharma USA Inc. Affected lots are #050725G-30 and #050725F-30 with expiration date 06/30/2026. A total of 50 bottles are involved in the nationwide distribution.
What You Should Do
Consumers should contact their healthcare provider regarding the recalled product.
Why This Matters
This Class II recall addresses a drug impurity exceeding FDA limits in a prescription medication distributed across the United States.
Source
FDA Recall D-0555-2026 - Asclemed USA Inc., Ongoing, initiated 2026-05-14.
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 (935 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 9, 2026.
Frequently Asked Questions
Common questions about this FDA recall.