CLASS II ONGOING Drug recall · Reported 15 Jan 2025 · FDA Enforcement Report

Duloxetine DR Capsules USP 60 mg, a) recalled by Rising Pharma Holding

Rising Pharma Holding is recalling Duloxetine DR Capsules USP 60 mg, a) (, distributed nationwide in the US. The recall was initiated on 30 Dec 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # a) DT6023053A, DT6023061A, DT6023068A, DT6023074A, exp. date Jan-25; DT6023078A, DT6023076A, exp. date Feb-25; DTC24043A, DTC24044A, exp. date Dec-25 b) DT6023002A, DT6023016A, DT6023036A, exp. date Dec-24; DT6023048A, exp. date Jan-25

Quantity recalled244,460 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-0190-2025
FDA event ID: 96074
Recalling firm: Rising Pharma Holding, East Brunswick, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 30 Dec 2024
FDA classified: 8 Jan 2025
Reported: 15 Jan 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity
Drug class: Antidepressants

Timeline

30 Dec 2024	Recall initiated by company
8 Jan 2025	Classified by FDA	+9 days
15 Jan 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 N-nitroso-duloxetine impurity above 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 DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ

Where it was distributed

Nationwide

Questions about this recall

Is Duloxetine DR Capsules USP 60 mg, a) ( recalled?

Yes. Rising Pharma Holding recalled Duloxetine DR Capsules USP 60 mg, a) ( on 30 Dec 2024. The recall is Class II and its status is Ongoing. Recall number D-0190-2025.

Why was it recalled?

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Which lots are affected?

Lot # a) DT6023053A, DT6023061A, DT6023068A, DT6023074A, exp. date Jan-25; DT6023078A, DT6023076A, exp. date Feb-25; DTC24043A, DTC24044A, exp. date Dec-25 b) DT6023002A, DT6023016A, DT6023036A, exp. date Dec-24; DT6023048A, exp. date Jan-25

Where was it sold?

Nationwide

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 Rising Pharma Holding

All 13

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Drug	CLASS II	Rising, Cyproheptadine Hydrochloride Syrup, 2mg recalledCyproheptadine Hydrochloride	Rising Pharma Holding	Particulate Matter	Nationwide
11 Mar 2026Drug	CLASS II	Product label: Temozolomide Capsules, 5mg recalledTemozolomide	Rising Pharma Holding	Potency & Assay	Nationwide
22 Oct 2025Drug	CLASS II	Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg recalledCarbidopa, Levodopa And Entacapone	Rising Pharma Holding	Packaging Defects	Nationwide
26 Mar 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 30 mg recalled	Rising Pharma Holding	Nitrosamine Impurity	Nationwide
15 Jan 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules USP 20 mg recalled	Rising Pharma Holding	Nitrosamine Impurity	Nationwide

Other Duloxetine dr recalls

All 3

Reported	Class	Recall	Company	Reason	Where
1 Jan 2025Drug	CLASS II	DULoxetine DR USP, 30 mg recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Nitrosamine Impurity	FL, MS, WI
11 Dec 2024Drug	CLASS II	Duloxetine DR Capsules USP 60 mg, a) recalled by Rising Pharma Holding	Rising Pharma Holding	Nitrosamine Impurity	Nationwide