CLASS II ONGOING Drug recall · Reported 11 Dec 2024 · 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 19 Nov 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) 30s; DT6023059A, DT6023060A, DT6023065A, DT6023069A, DT6023070A, exp. date Jan-25, DT6023080A, exp. date Feb-25, DT6023093A, exp. date Mar-25, DTC24012A, exp. date Dec-25; b) 90s; DT6023108A, exp. date Apr-25, DTC23201A, exp. date Aug-25; c) 1000s; DT6022160A, DT6022165A, DT6022162A, DT6022164A, DT6022163A, DT6022171A, DT6022169A, DT6022170A, DT6022173A, exp. date Nov-24, DT6023009A, DT6023007A, DT6023008A, DT6023011A, DT6023034B, exp. date Dec-24, DT6023067C, exp. date Jan-25, DT6023114A, exp. date Apr-25, DTC23243A, exp. date Oct-25, DTC24040A, exp. date Dec-25

Quantity recalled233,003 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-0107-2025
FDA event ID: 95756
Recalling firm: Rising Pharma Holding, East Brunswick, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 19 Nov 2024
FDA classified: 5 Dec 2024
Reported: 11 Dec 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity
Drug class: Antidepressants

Timeline

19 Nov 2024	Recall initiated by company
5 Dec 2024	Classified by FDA	+16 days
11 Dec 2024	Published in enforcement report	+6 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), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ

Where it was distributed

Nationwide.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

a) 30s; DT6023059A, DT6023060A, DT6023065A, DT6023069A, DT6023070A, exp. date Jan-25, DT6023080A, exp. date Feb-25, DT6023093A, exp. date Mar-25, DTC24012A, exp. date Dec-25; b) 90s; DT6023108A, exp. date Apr-25, DTC23201A, exp. date Aug-25; c) 1000s; DT6022160A, DT6022165A, DT6022162A, DT6022164A, DT6022163A, DT6022171A, DT6022169A, DT6022170A, DT6022173A, exp. date Nov-24, DT6023009A, DT6023007A, DT6023008A, DT6023011A, DT6023034B, exp. date Dec-24, DT6023067C, exp. date Jan-25, DT6023114A, exp. date Apr-25, DTC23243A, exp. date Oct-25, DTC24040A, exp. date Dec-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 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 95756

Reported	Class	Recall	Company	Reason	Where
11 Dec 2024	CLASS II	Duloxetine Delayed-Release Capsules USP, 30 mg, a) recalled	Rising Pharma Holding	Nitrosamine Impurity	Nationwide
11 Dec 2024	CLASS II	Duloxetine Delayed-Release Capsules USP, 20 mg recalled	Rising Pharma Holding	Nitrosamine Impurity	Nationwide

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 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