Medications & Supplements/Prescription Drugs

RemedyRepack Duloxetine Capsules Recalled for Nitrosamine Impurity

Agency Publication Date: December 26, 2024

Summary

RemedyRepack Inc. is recalling Duloxetine (duloxetine hydrochloride) Delayed-Release Capsules, 60 mg, because of a chemical impurity called N-nitroso-duloxetine. The recall affects 1,564 blister cards and 799 bottles of the medication. This impurity was found to be present at levels above the recommended limit set by the FDA.

Risk

The presence of N-nitroso-duloxetine, a type of nitrosamine impurity, at levels above the recommended interim limit may pose a risk of harm with long-term exposure. Nitrosamines are common in water and foods but are classified as probable human carcinogens when consumed at high levels over time.

What You Should Do

This recall affects Duloxetine Delayed-Release Capsules (60 mg) sold in 30-count blister cards (NDC 70518-0937-04) and 30-count bottles (NDC 70518-0937-03).
Check your packaging for lot number J0786744-061724 with an expiration date of 06/30/2025 on blister cards, or lot number B3002625-060524 with an expiration date of 10/31/2025 on bottles.
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 RemedyRepack Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

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 (60 mg, 30-count blister cards)

Variants: 60 mg, Blister cards

Lot Numbers:

J0786744-061724 (Exp 06/30/2025)

NDC:

70518-0937-04

Source NDC 57237-0019-99; MFG: Rising Pharma, Inc.

Product: Duloxetine Delayed-Release Capsules (60 mg, 30-count bottles)

Variants: 60 mg, Bottles

Lot Numbers:

B3002625-060524 (Exp 10/31/2025)

NDC:

70518-0937-03

Source NDC 57237-0019-99; MFG: Rising Pharma, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95900

Status: Active

Manufacturer: RemedyRepack Inc.

Sold By: Pharmacies; Healthcare facilities; Wholesale distributors

Manufactured In: United States

Units Affected: a) 1,564 cards, b) 799 bottles

Distributed To: Nationwide

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 (60 mg) sold in 30-count blister cards (NDC 70518-0937-04) and 30-count bottles (NDC 70518-0937-03).

Check your packaging for lot number J0786744-061724 with an expiration date of 06/30/2025 on blister cards, or lot number B3002625-060524 with an expiration date of 10/31/2025 on bottles.

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 RemedyRepack Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

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 (60 mg, 30-count blister cards)

Variants: 60 mg, Blister cards

Lot Numbers:

J0786744-061724 (Exp 06/30/2025)

NDC:

70518-0937-04

Source NDC 57237-0019-99; MFG: Rising Pharma, Inc.

Product: Duloxetine Delayed-Release Capsules (60 mg, 30-count bottles)

Variants: 60 mg, Bottles

Lot Numbers:

B3002625-060524 (Exp 10/31/2025)

NDC:

70518-0937-03

Source NDC 57237-0019-99; MFG: Rising Pharma, Inc.