CLASS II ONGOING Drug recall · Reported 11 Dec 2024 · FDA Enforcement Report

Duloxetine Delayed-Release Capsules, USP, 20 mg recalled

Amerisource Health Services is recalling Duloxetine Delayed-Release Capsules, USP, 20 mg, distributed in Ohio, Pennsylvania, Puerto Rico. The recall was initiated on 14 Nov 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: DT2023001A, DT2023009A, exp date Jan 31, 2025

Quantity recalled37,916 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0099-2025
FDA event ID: 95849
Recalling firm: Amerisource Health Services, Columbus, OH
Classification: Class II
Status: Ongoing
Recall initiated: 14 Nov 2024
FDA classified: 3 Dec 2024
Reported: 11 Dec 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity
Drug class: Antidepressants

Timeline

14 Nov 2024	Recall initiated by company
3 Dec 2024	Classified by FDA	+19 days
11 Dec 2024	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit

Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.

Product as listed by the FDA

Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06

Where it was distributed

PA, OH, PR

Ohio Pennsylvania Puerto Rico

Questions about this recall

Why was it recalled?

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit

Which lots are affected?

Lots: DT2023001A, DT2023009A, exp date Jan 31, 2025

Where was it sold?

PA, OH, PR

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 95849

This product is part of a recall event; the main page for the event is Duloxetine Delayed-Release Capsules, USP, 60 mg recalled.

Reported	Class	Recall	Company	Reason	Where
11 Dec 2024	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60 mg recalled	Amerisource Health Services	Nitrosamine Impurity	OH, PA, PR
11 Dec 2024	CLASS II	Duloxetine Delayed-Release Capsules, USP, 30 mg recalled	Amerisource Health Services	Nitrosamine Impurity	OH, PA, PR

More recalls from Amerisource Health Services

All 69

Reported	Class	Recall	Company	Reason	Where
27 May 2026Drug	CLASS III	Primidone Tablets, USP, 250 mg ( unit dose blister) recalledPrimidone	Amerisource Health Services	Packaging Defects	Nationwide
27 May 2026Drug	CLASS III	Primidone Tablets, USP, 50 mg ( unit dose blister) recalledPrimidone	Amerisource Health Services	Packaging Defects	Nationwide
1 Apr 2026Drug	CLASS II	Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) [] recalledMeclizine Hydrochloride	Amerisource Health Services	Packaging Defects	Nationwide
18 Feb 2026Drug	CLASS II	Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride	Amerisource Health Services	Packaging Defects	Nationwide
5 Nov 2025Drug	CLASS II	Prazosin Hydrochloride, Capsules, USP, 1 mg recalledPrazosin Hydrochloride	Amerisource Health Services	Nitrosamine Impurity	Nationwide

Other Duloxetine recalls

All 57

Reported	Class	Recall	Company	Reason	Where
17 Jun 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 30mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
17 Jun 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
10 Jun 2026Drug	CLASS II	Duloxetine DR Capsules, 30 mg, Rx, Relabeled recalled by Asclemed USADuloxetine	Asclemed USA	Nitrosamine Impurity	Nationwide
13 May 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules, 60 mg recalled by Ajanta PharmaDuloxetine	Ajanta Pharma	Nitrosamine Impurity	Nationwide
13 May 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules USP, 60mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide