Duloxetine DR Capsules Recall Due to Nitrosamine Impurity

Source: FDA · United States

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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 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.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, drugs) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

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 ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
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.
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.