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Unrated Drug recall · FDA · Published April 29, 2026

Ajanta Pharma Recalls Duloxetine Capsules Due to Nitrosamine Impurity Risk

Ajanta Pharma recalls 30mg Duloxetine Delayed-Release Capsules with N-nitroso-Duloxetine impurity above FDA limits. Consumers should check NDC numbers and lot dates for affected batches.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0514-2026DrugAjanta Pharma ›
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Contact the company

Recalling firmAjanta Pharma Ltd.B-4/5/6 MIDC Industrial Area, Paithan · Aurangabad, India
✎ GovInfoNow plain-language explainer

Ajanta Pharma is recalling specific batches of 30mg Duloxetine Delayed-Release Capsules due to a harmful chemical impurity found in some products. This impurity could pose a health risk if taken by people who need the medication. Read more at govinfonow.com/recall/31323-ajanta-pharma-recalls-duloxetine-capsules-due-to-nitrosamine-impurity-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/31323-ajanta-pharma-recalls-duloxetine-capsules-due-to-nitrosamine-impurity-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0514-2026

Cite this page

“Ajanta Pharma Recalls Duloxetine Capsules Due to Nitrosamine Impurity Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31323-ajanta-pharma-recalls-duloxetine-capsules-due-to-nitrosamine-impurity-risk. Based on FDA recall #D-0514-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0514-2026%22&limit=1).

The FDA announced on April 29, 2026, that Ajanta Pharma Ltd. is voluntarily recalling Duloxetine Delayed-Release Capsules due to CGMP deviations involving an N-nitroso-Duloxetine impurity exceeding the recommended limit. The agency stated the recall covers specific lots distributed nationwide.

How to tell if you have it

  • Brand: Ajanta Pharma
  • Product: Duloxetine Delayed-Release Capsules, 30 mg, Rx Only
  • NDC 27241-098-09 (90 Capsules), Lot PA10774, Exp. May 2026
  • NDC 27241-098-03 (30 capsules), Lots PA10794, PA12174, Exp. Jun 2026
  • NDC 27241-098-10 (1000 Capsules), Lot PA10804, Exp. Jun-26

The hazard

The recall addresses CGMP deviations where the presence of N-nitroso-Duloxetine impurity was found above the FDA recommended limit of 0.83 ppm at the 12-month and 18-month long-term stability intervals. The record does not report specific incidents or injuries associated with this finding.

Context

GovInfoNow's records show other recent recalls of similar products include Asclemed Duloxetine Capsules Recall: Nitrosamine Impurity Risk (2026-05-14) and Breckenridge Duloxetine Capsules Recall: N-nitroso impurity risk (2026-06-04). Additional records list a Breckenridge Duloxetine Capsules Recall: N-nitroso-duloxetine Impurity Risk on 2026-06-04.

How to tell if you have this one

Check the product label for NDC numbers: 27241-098-09 (90 capsules), 27241-098-03 (30 capsules), or 27241-098-10 (1000 capsules). Also check the lot number and expiration date on the packaging.

  • Brand
    Ajanta Pharma
  • Category
    Drug
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Nationwide within U.S
  • NDC
    27241-097-06, 27241-097-10, 27241-097-90, 27241-097-05, 27241-098-03, 27241-098-09, 27241-098-10, 27241-164-30, 27241-099-03, 27241-099-90, 27241-099-40
Recall numberProduct, codes & lotsQuantity
D-0514-2026Duloxetine 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; Lot#: a) PA10774, Exp. May 2026; b) PA10794, PA12174, Exp. Jun 2026; c) PA10804, Exp. Jun-26.312,894 packs
D-0515-2026Duloxetine 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; Lot#: PA07434, Exp. May 2026.77,376 packs.
D-0516-2026Duloxetine 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.; Lot#: PA10734, Exp. Jun 2026.117,168 packs
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the NDC numbers 27241-098-09, 27241-098-03, or 27241-098-10 on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide within U.S” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 14 days after the firm started it.

1. Firm started the recall: Apr 29, 202612. FDA classified it Class II: May 4, 202623. Published in FDA’s Enforcement Report: May 13, 202632026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Asclemed Duloxetine Capsules Recall: Nitrosamine Impurity Risk
Asclemed USABreckenridge Duloxetine Capsules Recall: N-nitroso impurity risk
Breckenridge PharmaceuticalBreckenridge Duloxetine Capsules Recall: N-nitroso-duloxetine Impurity Risk
BreckenridgeAmerican Health Packaging Recalls Metoclopramide Tablets Due to Foreign Drug Presence
American Health PackagingTeva Recalls Metoclopramide Tablets Due to Foreign Contaminants
Teva Pharmaceuticals USA, Inc

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Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0514-2026 (April 29, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0514-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA