Preferred Pharmaceuticals recalls Duloxetine 30mg bottles with N-nitroso impurity risk
Preferred Pharmaceuticals recalls 30mg Duloxetine bottles due to potential N-nitroso impurity above FDA limits. This may pose health risks. Consumers should contact the company for details.
Recall notice
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Contact the company
What happened, in plain English
Preferred Pharmaceuticals is recalling Duloxetine Delayed-Release Cap USP 30mg bottles because they contain an impurity (N-nitroso-duloxetine) that exceeds FDA safety limits. This could pose health risks to people taking the medication. Read more at govinfonow.com/recall/32686-preferred-pharmaceuticals-recalls-duloxetine-30mg-bottles-with-n-nitroso-impurity.
Source Summary by GovInfoNow · govinfonow.com/recall/32686-preferred-pharmaceuticals-recalls-duloxetine-30mg-bottles-with-n-nitroso-impurity · Updated August 17, 2026 · FDA enforcement record: FDA #D-0505-2024
Cite this page
“Preferred Pharmaceuticals recalls Duloxetine 30mg bottles with N-nitroso impurity risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32686-preferred-pharmaceuticals-recalls-duloxetine-30mg-bottles-with-n-nitroso-impurity. Based on FDA recall #D-0505-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0505-2024%22&limit=1).
Why it’s dangerous
The recall is due to the presence of N-nitroso-duloxetine impurities in the medication. This impurity exceeds the FDA's recommended safety limits and could potentially cause health issues when taken.
Who’s affected
People who have been prescribed Duloxetine Delayed-Release Cap USP 30mg bottles with NDC 68788-9301-03 are affected. Those taking this medication for depression or other conditions are at risk.
How to tell if you have this one
Check for the product name 'Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only' with NDC 68788-9301-03. The lot number J2022G and expiration date 01/01/2025 are also on the label.
- Brand
Preferred Pharmaceuticals- Category
Drug
What to do — step by step
Contact Manufacturer
Reach out to Preferred Pharmaceuticals for specific instructions on handling the recalled product.
Where it went and when
Where it was distributed
Distributed in 5 states.
FDA distribution: “Product distributed to CA, FL, OK, KS and CT” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Connecticut, Florida, Kansas, Oklahoma.
Recall timeline
FDA published this recall 19 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Other Preferred Pharmaceuticals recalls
Latest drug recalls
Keep exploring
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-0505-2024 (May 10, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0505-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.