CLASS II Drug recall · Reported 5 Feb 2025 · FDA Enforcement Report

Duloxetine Delayed-Release Capsules USP, 20 mg recalled

The Harvard Drug Group is recalling Duloxetine Delayed-Release Capsules USP, 20 mg, distributed nationwide in the US. The recall was initiated on 13 Jan 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: a) N01530, Exp. Date 01/2025; b) N01540, Exp. Date. 01/2025

Quantity recalleda) 6408 boxes and b)1488 boxes

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-0212-2025
FDA event ID: 96105
Recalling firm: The Harvard Drug Group, La Vergne, TN
Classification: Class II
Status: Terminated
Recall initiated: 13 Jan 2025
FDA classified: 29 Jan 2025
Reported: 5 Feb 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity
Drug class: Antidepressants

Timeline

13 Jan 2025	Recall initiated by company
29 Jan 2025	Classified by FDA	+16 days
5 Feb 2025	Published in enforcement report	+7 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 Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake 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, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.

Where it was distributed

Nationwide within the United States

Nationwide

Questions about this recall

Is Duloxetine Delayed-Release Capsules USP, 20 mg recalled?

Yes. The Harvard Drug Group recalled Duloxetine Delayed-Release Capsules USP, 20 mg on 13 Jan 2025. The recall is Class II and its status is Terminated. Recall number D-0212-2025.

Why was it recalled?

CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit

Which lots are affected?

Lot #: a) N01530, Exp. Date 01/2025; b) N01540, Exp. Date. 01/2025

Where was it sold?

Nationwide within the United States

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

More recalls from The Harvard Drug Group

All 79

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1 Jul 2026Drug	CLASS II	Carton Label: Major, Methylergonovine Maleate Tablets recalledMethylergonovine Maleate	The Harvard Drug Group	Potency & Assay	Nationwide
29 Apr 2026Drug	CLASS II	Omega-3-Acid, Ethyl Esters, Capsules recalled by The Harvard Drug GroupOmega-3-acid Ethyl Esters	The Harvard Drug Group	Potency & Assay	Nationwide
22 Apr 2026Drug	CLASS II	Memantine Hydrochloride Extended-Release, Capsules, 7 mg recalledMemantine Hydrochloride	The Harvard Drug Group	Potency & Assay	Nationwide
11 Mar 2026Drug	CLASS II	Midodrine Hydrochloride Tablets, USP, 5 mg ( blister packs) recalledMidodrine Hydrochloride	The Harvard Drug Group	Packaging Defects	Nationwide
29 Oct 2025Drug	CLASS II	Gabapentin Capsules, USP, 100 mg ( blister packs) recalledGabapentin	The Harvard Drug Group	Potency & Assay	Nationwide

Other Duloxetine recalls

All 55

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