Duloxetine Delayed-Release Capsules, 30 mg recall — Ajanta Pharma Ltd. (Class II)

Regulatory snapshot

Reason reported by FDA

CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

22 words from the enforcement report field reason_for_recall, reproduced without edit — the firm's own wording, not an assessment.

Product identifiers in this record

10 identifying values matched by exact pattern in the 34-word product description above; each is a literal substring of it.

Which configuration this record is

3 recall numbers share event 98785. They differ on strength, package and ndc and agree on everything else the source states, so those are the values to check a package against.

Shared across all 3 records under this event: form Delayed-Release Capsules; product named Duloxetine Delayed-Release Capsules; fda tier Class II; recalling firm Ajanta Pharma Ltd.; the same reason text; initiated 2026-04-29; reported 2026-05-13.

Reading this record

Class II is the FDA's own severity tier for the recall action — 213 of the 250 indexed records carry it — and it describes the agency's assessment of the action, not a risk statement about any individual. A search on event 98785 returns all 3 of these recall numbers; a search on D-0514-2026 returns only this configuration. Match a package against 27241-098-09, 27241-098-03 and 27241-098-10 at the FDA source to confirm it is covered.

Namespace context: the Class II index (213 records) and the recall hub (250 records, 118 FDA events); Ajanta Pharma Ltd. (3 indexed records) aggregates this firm across datasets.

• What a Class II recall means
• What "Ongoing" recall status means
• How to search FDA drug recalls by NDC
• How to monitor a manufacturer’s recall history

Coverage and limits of this record

This page reflects the openFDA enforcement report for D-0514-2026 as ingested on 2026-08-22, which can lag the live FDA record and omits detail held only in primary documents. It offers no clinical assessment, no advice about whether to use any product, and no substitute. For any health question consult a qualified healthcare professional.