Medications & Supplements/Prescription Drugs

Direct Rx Duloxetine D/R Recalled for Nitrosamine Impurity

Agency Publication Date: August 4, 2025

Summary

Direct Rx is recalling 891 bottles of Duloxetine D/R (delayed-release) capsules in 20 mg and 30 mg strengths. This recall was issued because the medication was found to contain a nitrosamine impurity at levels higher than the acceptable interim limit. The recalled products include various bottle sizes distributed across the United States.

Risk

Nitrosamines are impurities that may increase the risk of cancer if individuals are exposed to them at high levels over a long period of time. No injuries or adverse events have been reported to date.

What You Should Do

This recall affects Direct Rx Duloxetine D/R capsules (delayed-release) in 20 mg and 30 mg strengths, distributed in 30, 60, and 90-count bottles.
Identify your medication by checking the label for NDC numbers 61919-422-30, 61919-0482-30, 61919-0482-60, or 61919-0482-90 and the specific lot numbers and expiration dates. 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 Direct Rx for further instructions.
For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332.

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 D/R, 20 mg (30-count bottle)

Variants: 20 mg, Delayed-Release Capsules, 30 Caps

Lot Numbers:

02AU2406 (Exp 01/31/2027)

NDC:

61919-422-30

Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc.

Product: Duloxetine D/R, 30 mg

Variants: 30 mg, Delayed-Release Capsules, 30-count bottle, 60-count bottle, 90-count bottle

Lot Numbers:

15AU2420 (Exp 01/31/2027)

01JY2407 (Exp 01/31/2027)

04OC2411 (Exp 01/31/2027)

12SE2418 (Exp 03/31/2027)

24OC2424 (Exp 03/31/2027)

20NO2416 (Exp 03/31/2027)

21AU2313 (Exp 01/31/2026)

21JY2311 (Exp 01/31/2026)

05JY2313 (Exp 01/31/2026)

13OC2310 (Exp 01/31/2026)

05SE2304 (Exp 01/31/2026)

04AU2306 (Exp 01/31/2026)

21JY2317 (Exp 01/31/2026)

12JY2306 (Exp 01/31/2026)

11JY2416 (Exp 01/31/2027)

28JU2414 (Exp 01/31/2027)

19AU2412 (Exp 01/31/2027)

02AU2409 (Exp 01/31/2027)

11SE2416 (Exp 03/31/2027)

24OC2425 (Exp 03/31/2027)

23AU2317 (Exp 01/31/2026)

21AU2314 (Exp 01/31/2026)

NDC:

61919-0482-30

61919-0482-60

61919-0482-90

Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97251

Status: Active

Manufacturer: Direct Rx

Sold By: Pharmacies; Breckenridge Pharm., Inc.

Manufactured In: United States

Units Affected: 2 products (16 bottles; 875 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 Direct Rx Duloxetine D/R capsules (delayed-release) in 20 mg and 30 mg strengths, distributed in 30, 60, and 90-count bottles.

Identify your medication by checking the label for NDC numbers 61919-422-30, 61919-0482-30, 61919-0482-60, or 61919-0482-90 and the specific lot numbers and expiration dates. 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 Direct Rx for further instructions.

For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332.

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 D/R, 20 mg (30-count bottle)

Variants: 20 mg, Delayed-Release Capsules, 30 Caps

Lot Numbers:

02AU2406 (Exp 01/31/2027)

NDC:

61919-422-30

Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc.

Product: Duloxetine D/R, 30 mg

Variants: 30 mg, Delayed-Release Capsules, 30-count bottle, 60-count bottle, 90-count bottle

Lot Numbers:

15AU2420 (Exp 01/31/2027)

01JY2407 (Exp 01/31/2027)

04OC2411 (Exp 01/31/2027)

12SE2418 (Exp 03/31/2027)

24OC2424 (Exp 03/31/2027)

20NO2416 (Exp 03/31/2027)

21AU2313 (Exp 01/31/2026)

21JY2311 (Exp 01/31/2026)

05JY2313 (Exp 01/31/2026)

13OC2310 (Exp 01/31/2026)

05SE2304 (Exp 01/31/2026)

04AU2306 (Exp 01/31/2026)

21JY2317 (Exp 01/31/2026)

12JY2306 (Exp 01/31/2026)

11JY2416 (Exp 01/31/2027)

28JU2414 (Exp 01/31/2027)

19AU2412 (Exp 01/31/2027)

02AU2409 (Exp 01/31/2027)

11SE2416 (Exp 03/31/2027)

24OC2425 (Exp 03/31/2027)

23AU2317 (Exp 01/31/2026)

21AU2314 (Exp 01/31/2026)

NDC:

61919-0482-30

61919-0482-60

61919-0482-90

Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc.