Medications & Supplements/Prescription Drugs

Breckenridge Duloxetine Capsules Recalled for Nitrosamine Impurity

Agency Publication Date: April 22, 2025

Summary

Breckenridge Pharmaceutical, Inc. is recalling 359,817 bottles of Duloxetine Delayed-Release Capsules USP (30 mg and 60 mg), a medication commonly used to treat depression, anxiety, and certain types of chronic pain. The recall was initiated following tests that revealed the presence of a nitrosamine impurity at levels exceeding the FDA's proposed safety limits. Patients currently taking this medication should consult their healthcare provider or pharmacist before stopping use.

Risk

Nitrosamines are impurities that are classified as probable human carcinogens. Long-term exposure to these substances at levels above the recommended safety limits may increase the risk of developing cancer.

What You Should Do

This recall affects Breckenridge Pharmaceutical Duloxetine Delayed-Release Capsules USP in 30 mg and 60 mg strengths, manufactured by Towa Pharmaceutical Europe.
Affected 60 mg capsules (1,000-count bottles, NDC 51991-748-10) include lot numbers 240987C and 241014C with expiration dates of April 2027.
Affected 30 mg capsules (90-count NDC 51991-747-90 and 1,000-count NDC 51991-747-10) include lot numbers 230201C, 230471C, and 230288C with expiration dates of January 2026.
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 Breckenridge Pharmaceutical, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) 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, 60 mg (1,000-count bottles)

Variants: 60 mg, 1000-count

Lot Numbers:

240987C (Exp 04/2027)

241014C (Exp 04/2027)

NDC:

51991-748-10

Rx Only; Manufactured by Towa Pharmaceutical Europe, S.L.

Product: Duloxetine Delayed-Release Capsules USP, 30 mg (90-count bottles)

Variants: 30 mg, 90-count

Lot Numbers:

230201C (Exp 01/2026)

230471C (Exp 01/2026)

230288C (Exp 01/2026)

NDC:

51991-747-90

Rx Only; Manufactured by Towa Pharmaceutical Europe, S.L.

Product: Duloxetine Delayed-Release Capsules USP, 30 mg (1,000-count bottles)

Variants: 30 mg, 1000-count

Lot Numbers:

230201C (Exp 01/2026)

230471C (Exp 01/2026)

230288C (Exp 01/2026)

NDC:

51991-747-10

Rx Only; Manufactured by Towa Pharmaceutical Europe, S.L.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96707

Status: Active

Manufacturer: Breckenridge Pharmaceutical, Inc

Sold By: Retail Pharmacies

Manufactured In: United States, Spain

Units Affected: 2 products (16,473 bottles; 343,344 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 Breckenridge Pharmaceutical Duloxetine Delayed-Release Capsules USP in 30 mg and 60 mg strengths, manufactured by Towa Pharmaceutical Europe.

Affected 60 mg capsules (1,000-count bottles, NDC 51991-748-10) include lot numbers 240987C and 241014C with expiration dates of April 2027.

Affected 30 mg capsules (90-count NDC 51991-747-90 and 1,000-count NDC 51991-747-10) include lot numbers 230201C, 230471C, and 230288C with expiration dates of January 2026.

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 Breckenridge Pharmaceutical, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) 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, 60 mg (1,000-count bottles)

Variants: 60 mg, 1000-count

Lot Numbers:

240987C (Exp 04/2027)

241014C (Exp 04/2027)

NDC:

51991-748-10

Rx Only; Manufactured by Towa Pharmaceutical Europe, S.L.

Product: Duloxetine Delayed-Release Capsules USP, 30 mg (90-count bottles)

Variants: 30 mg, 90-count

Lot Numbers:

230201C (Exp 01/2026)

230471C (Exp 01/2026)

230288C (Exp 01/2026)

NDC:

51991-747-90

Rx Only; Manufactured by Towa Pharmaceutical Europe, S.L.

Product: Duloxetine Delayed-Release Capsules USP, 30 mg (1,000-count bottles)

Variants: 30 mg, 1000-count

Lot Numbers:

230201C (Exp 01/2026)

230471C (Exp 01/2026)

230288C (Exp 01/2026)

NDC:

51991-747-10

Rx Only; Manufactured by Towa Pharmaceutical Europe, S.L.