--- title: "Ajanta Pharma Ltd. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Ajanta Pharma Ltd. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/ajanta-pharma-ltd/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Ajanta Pharma Ltd. recall records **3** reported ongoing 3 records in this archive. Latest source date Apr 29, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Apr 29, 2026 FDA drug enforcement ### [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 ...](https://isitonrecall.com/recall/fda-drug-d-0514-2026-duloxetine-delayed-release-capsules-30-mg-rx-only-a-90-capsules-ndc-27241-098-09-b-30-capsules-ndc-2/) 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. Class II Reported ongoing Distribution: Nationwide within U.S [Official source for Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 caps...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0514-2026%22) Apr 29, 2026 FDA drug enforcement ### [Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03](https://isitonrecall.com/recall/fda-drug-d-0515-2026-duloxetine-delayed-release-capsules-60-mg-rx-only-30-capsules-marketed-by-ajanta-pharma-usa-inc-brid/) 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. Class II Reported ongoing Distribution: Nationwide within U.S [Official source for Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0515-2026%22) Apr 29, 2026 FDA drug enforcement ### [Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.](https://isitonrecall.com/recall/fda-drug-d-0516-2026-duloxetine-delayed-release-capsules-20-mg-rx-only-60-capsules-marketed-by-ajanta-pharma-usa-inc-brid/) 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. Class II Reported ongoing Distribution: Nationwide within U.S [Official source for Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0516-2026%22) ## Reasons in these listed records - 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. These examples come from this result page and are not a ranking of every recall reason. ## Checking Ajanta Pharma Ltd. ### Is there a recall on ajanta pharma ltd. right now? This archive contains 3 records, including 3 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Ajanta Pharma Ltd.](https://isitonrecall.com/check/?q=Ajanta%20Pharma%20Ltd.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)