Medications & Supplements/Prescription Drugs

Rising Pharma Duloxetine Capsules Recalled for Nitrosamine Impurity

Agency Publication Date: December 5, 2024

Summary

Rising Pharma Holding, Inc. has recalled 565,304 bottles of Duloxetine Delayed-Release Capsules USP (duloxetine) in 20 mg, 30 mg, and 60 mg strengths. The recall was issued because tests found an impurity called N-nitroso-duloxetine at levels exceeding the FDA's recommended safety limits. This prescription medication is commonly used to treat depression, anxiety, and certain types of nerve or muscle pain.

Risk

N-nitroso-duloxetine belongs to a class of chemicals called nitrosamines, which are classified as probable human carcinogens. While there is no immediate health risk from these levels, long-term exposure to nitrosamine impurities above safety limits may increase the risk of developing cancer.

What You Should Do

This recall affects Duloxetine Delayed-Release Capsules USP in 20 mg, 30 mg, and 60 mg strengths distributed by Rising Pharma Holdings, Inc. and sold in 30, 60, 90, and 1,000 count bottles.
Check your medication bottle for NDC codes 57237-017-60, 57237-018-30, 57237-018-90, 57237-018-99, 57237-019-30, 57237-019-90, or 57237-019-99. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Duloxetine Delayed-Release Capsules USP (20 mg)

Variants: 20 mg, 60 count bottle

Lot Numbers:

DT2022023A (Exp Nov-24)

DT2022024A (Exp Nov-24)

DT2022025A (Exp Nov-24)

DT2022026A (Exp Nov-24)

DT2022027A (Exp Nov-24)

DT2023001B (Exp Jan-25)

DT2023004A (Exp Jan-25)

DT2023005A (Exp Jan-25)

DT2023006A (Exp Jan-25)

NDC:

57237-017-60

Distributed by Rising Pharma Holdings, Inc., East Brunswick, NJ

Product: Duloxetine Delayed-Release Capsules USP (30 mg)

Variants: 30 mg, 30 count bottle, 90 count bottle, 1000 count bottle

Lot Numbers:

DT3023019A (Exp Jan-25)

DT3023050A (Exp Apr-25)

DT3023022A (Exp Jan-25)

DT3022108A (Exp Nov-24)

DT3022107A (Exp Nov-24)

DT3022106A (Exp Nov-24)

DT3022111A (Exp Nov-24)

DT3022109A (Exp Nov-24)

DT3023001A (Exp Dec-24)

DT3023003A (Exp Dec-24)

DT3023024A (Exp Jan-25)

DT3023020B (Exp Jan-25)

DT3023027A (Exp Feb-25)

DT3023028A (Exp Feb-25)

DT3023034A (Exp Mar-25)

DT3023049A (Exp Apr-25)

DT3023095A (Exp Jul-25)

NDC:

57237-018-30

57237-018-90

57237-018-99

Distributed by Rising Pharma Holdings, Inc., East Brunswick, NJ

Product: Duloxetine Delayed-Release Capsules USP (60 mg)

Variants: 60 mg, 30 count bottle, 90 count bottle, 1000 count bottle

Lot Numbers:

DT6023059A (Exp Jan-25)

DT6023060A (Exp Jan-25)

DT6023065A (Exp Jan-25)

DT6023069A (Exp Jan-25)

DT6023070A (Exp Jan-25)

DT6023080A (Exp Feb-25)

DT6023093A (Exp Mar-25)

DTC24012A (Exp Dec-25)

DT6023108A (Exp Apr-25)

DTC23201A (Exp Aug-25)

DT6022160A (Exp Nov-24)

DT6022165A (Exp Nov-24)

DT6022162A (Exp Nov-24)

DT6022164A (Exp Nov-24)

DT6022163A (Exp Nov-24)

DT6022171A (Exp Nov-24)

DT6022169A (Exp Nov-24)

DT6022170A (Exp Nov-24)

DT6022173A (Exp Nov-24)

DT6023009A (Exp Dec-24)

DT6023007A (Exp Dec-24)

DT6023008A (Exp Dec-24)

DT6023011A (Exp Dec-24)

DT6023034B (Exp Dec-24)

DT6023067C (Exp Jan-25)

DT6023114A (Exp Apr-25)

DTC23243A (Exp Oct-25)

DTC24040A (Exp Dec-25)

NDC:

57237-019-30

57237-019-90

57237-019-99

Distributed by Rising Pharma Holdings, Inc. and Rising Pharmaceuticals, Inc., East Brunswick, NJ

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95756

Status: Active

Manufacturer: Rising Pharma Holding, Inc.

Sold By: Authorized distributors; Pharmacies

Manufactured In: United States

Units Affected: 3 products (209,376 bottles; 122,925 bottles; 233,003 bottles)

Distributed To: Nationwide

Agency Last Updated: December 6, 2024

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Duloxetine Delayed-Release Capsules USP in 20 mg, 30 mg, and 60 mg strengths distributed by Rising Pharma Holdings, Inc. and sold in 30, 60, 90, and 1,000 count bottles.

Check your medication bottle for NDC codes 57237-017-60, 57237-018-30, 57237-018-90, 57237-018-99, 57237-019-30, 57237-019-90, or 57237-019-99. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Duloxetine Delayed-Release Capsules USP (20 mg)

Variants: 20 mg, 60 count bottle

Lot Numbers:

DT2022023A (Exp Nov-24)

DT2022024A (Exp Nov-24)

DT2022025A (Exp Nov-24)

DT2022026A (Exp Nov-24)

DT2022027A (Exp Nov-24)

DT2023001B (Exp Jan-25)

DT2023004A (Exp Jan-25)

DT2023005A (Exp Jan-25)

DT2023006A (Exp Jan-25)

NDC:

57237-017-60

Distributed by Rising Pharma Holdings, Inc., East Brunswick, NJ

Product: Duloxetine Delayed-Release Capsules USP (30 mg)

Variants: 30 mg, 30 count bottle, 90 count bottle, 1000 count bottle

Lot Numbers:

DT3023019A (Exp Jan-25)

DT3023050A (Exp Apr-25)

DT3023022A (Exp Jan-25)

DT3022108A (Exp Nov-24)

DT3022107A (Exp Nov-24)

DT3022106A (Exp Nov-24)

DT3022111A (Exp Nov-24)

DT3022109A (Exp Nov-24)

DT3023001A (Exp Dec-24)

DT3023003A (Exp Dec-24)

DT3023024A (Exp Jan-25)

DT3023020B (Exp Jan-25)

DT3023027A (Exp Feb-25)

DT3023028A (Exp Feb-25)

DT3023034A (Exp Mar-25)

DT3023049A (Exp Apr-25)

DT3023095A (Exp Jul-25)

NDC:

57237-018-30

57237-018-90

57237-018-99

Distributed by Rising Pharma Holdings, Inc., East Brunswick, NJ

Product: Duloxetine Delayed-Release Capsules USP (60 mg)

Variants: 60 mg, 30 count bottle, 90 count bottle, 1000 count bottle

Lot Numbers:

DT6023059A (Exp Jan-25)

DT6023060A (Exp Jan-25)

DT6023065A (Exp Jan-25)

DT6023069A (Exp Jan-25)

DT6023070A (Exp Jan-25)

DT6023080A (Exp Feb-25)

DT6023093A (Exp Mar-25)

DTC24012A (Exp Dec-25)

DT6023108A (Exp Apr-25)

DTC23201A (Exp Aug-25)

DT6022160A (Exp Nov-24)

DT6022165A (Exp Nov-24)

DT6022162A (Exp Nov-24)

DT6022164A (Exp Nov-24)

DT6022163A (Exp Nov-24)

DT6022171A (Exp Nov-24)

DT6022169A (Exp Nov-24)

DT6022170A (Exp Nov-24)

DT6022173A (Exp Nov-24)

DT6023009A (Exp Dec-24)

DT6023007A (Exp Dec-24)

DT6023008A (Exp Dec-24)

DT6023011A (Exp Dec-24)

DT6023034B (Exp Dec-24)

DT6023067C (Exp Jan-25)

DT6023114A (Exp Apr-25)

DTC23243A (Exp Oct-25)

DTC24040A (Exp Dec-25)

NDC:

57237-019-30

57237-019-90

57237-019-99

Distributed by Rising Pharma Holdings, Inc. and Rising Pharmaceuticals, Inc., East Brunswick, NJ

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95756

Status: Active

Manufacturer: Rising Pharma Holding, Inc.

Sold By: Authorized distributors; Pharmacies

Manufactured In: United States

Units Affected: 3 products (209,376 bottles; 122,925 bottles; 233,003 bottles)

Distributed To: Nationwide

Agency Last Updated: December 6, 2024