Recall: Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India

FDA recall data

Reason for recall (source data field)

The following text is the recalling firm's stated reason, reproduced verbatim from the FDA enforcement report as a regulatory data field. It is presented for identification and verification only — it is not a safety instruction, a clinical assessment, or advice.

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.

How to interpret this recall record

A recall record means a firm has removed or corrected a marketed product in cooperation with the FDA, and that the agency has logged the action in its enforcement reports. The classification (Class II) is the FDA's regulatory severity tier for the action; it describes the agency's assessment of the recall event in administrative terms, not a personalised risk statement for any individual. The status (Ongoing) reflects where the recall sits in its lifecycle. Read this entry as a pointer to an official report: open the linked FDA source to confirm the product, lot scope, dates, and current status before acting on any of it.

What this record does not mean

This recall record does not constitute medical advice and does not tell you whether to start, stop, switch, or avoid any product. It does not assess safety for any individual, does not provide dosage, treatment, or therapeutic guidance, and does not diagnose any condition. The dataset is coverage-limited: it reflects what the FDA has published in the indexed source at ingestion time, which may lag the live record and may omit details held only in primary documents. For any health decision, consult a qualified healthcare professional, and for the authoritative record consult the FDA directly through the linked official source.

Related manufacturer

This recall is attributed to Ajanta Pharma Ltd.. That page aggregates the firm's other indexed recall and shortage records as coverage-limited regulatory signals (not quality ratings).

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