Unrated Drug recall · FDA · Published March 7, 2025

Direct Rx Duloxetine 20mg 30-count bottle recall: Nitrosamine impurity risk

Direct Rx recalls 20mg Duloxetine 30-count bottles due to nitrosamine impurity exceeding safety limits. Consumers should check lot numbers and contact the manufacturer for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0567-2025Drug Direct Rx ›

Recall notice

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Take action

Contact the company

Recalling firmDirect Rx94 Worldwide Dr · Dawsonville, GA 30534-6828

✎ GovInfoNow plain-language explainer

Direct Rx is recalling 20mg Duloxetine 30-count bottles because they contain a harmful nitrosamine impurity above safety limits. This could pose a health risk to users, so affected individuals should stop using the product and contact the manufacturer. Read more at govinfonow.com/recall/32232-direct-rx-duloxetine-20mg-30-count-bottle-recall-nitrosamine-impurity.

Source Summary by GovInfoNow · govinfonow.com/recall/32232-direct-rx-duloxetine-20mg-30-count-bottle-recall-nitrosamine-impurity · Updated August 18, 2026 · FDA enforcement record: FDA #D-0567-2025

Cite this page

“Direct Rx Duloxetine 20mg 30-count bottle recall: Nitrosamine impurity risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/32232-direct-rx-duloxetine-20mg-30-count-bottle-recall-nitrosamine-impurity. Based on FDA recall #D-0567-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0567-2025%22&limit=1).

The FDA announced on March 7, 2025, that Direct Rx voluntarily recalled Duloxetine D/R, 20 mg, 30-count bottles due to CGMP deviations involving nitrosamine impurities above the proposed interim limit. The recall affects 16 bottles distributed nationwide.

How to tell if you have it

Brand: Direct Rx
Product: Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle
NDC: 61919-422-30
Lot #: 02AU2406
Expiration: 01/31/2027
Quantity: 16 bottles

The hazard

The recall is due to CGMP deviations involving the presence of a nitrosamine drug substance related impurity above the proposed interim limit, according to the FDA.

Context

GovInfoNow's records show Direct Rx has had 19 other recalls since March 12, 2019. Other recent recalls include a June 22, 2026 recall for Duloxetine D/R 30mg capsules due to N-nitroso-duloxetine impurity risk and an Aug. 9, 2024 recall for Ibuprofen 800mg tablets due to failed impurity specifications. Similar recent recalls of duloxetine products include Asclemed's May 14, 2026 recall, Ajanta Pharma's April 29, 2026 recall, and Breckenridge's June 4, 2026 recall, all citing nitrosamine impurity risks.

How to tell if you have this one

Check for the 20mg Duloxetine 30-count bottle with lot number 02AU2406 (expiring Jan 2027). The product is distributed by Direct Rx and sold through pharmacies in the US.

Brand
Direct Rx
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide

Recall number	Product, codes & lots	Quantity
D-0567-2025	Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30; Lot #: 02AU2406, Exp 01/31/2027	16 bottles
D-0568-2025	Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,; Lot #: a) 15AU2420, 01JY2407, 04OC2411, Exp 01/31/2027; 12SE2418, 24OC2424, 20NO2416, Exp 03/31/2027; 21AU2313, 21JY2311, 05JY2313, Exp Date 01/31/2026 b) 13OC2310, 05SE2304, 04AU2306, 21JY2317, 12JY2306, Exp 01/31/2026; 11JY2416, 28JU2414, 19AU2412, 02AU2409, Exp 01/31/2027; 11SE2416, 24OC2425, Exp 03/31/2027; c) 23AU2317, 21AU2314, Exp 01/31/2026.	875 bottles

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the lot number on the bottle, which should be 02AU2406 for this recall.
Contact Manufacturer
Reach out to Direct Rx for further instructions on how to return or dispose of the product.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 5 months after the firm started it.

Mar 7, 2025Firm started the recall
Aug 4, 2025FDA classified it Class II
Aug 13, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/32232-direct-rx-duloxetine-20mg-30-count-bottle-recall-nitrosamine-impurity">Direct Rx Duloxetine 20mg 30-count bottle recall: Nitrosamine impurity risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0567-2025 (March 7, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0567-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.