PD-Rx DULoxetine 30mg 90-count recall: Nitrosamine impurity risk
PD-Rx Pharmaceuticals recalls DULoxetine 30mg 90-count bottles due to potential nitrosamine impurity. This may pose health risks. Consumers should contact the company for details.
Recall notice
CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
Contact the company
What happened, in plain English
PD-Rx Pharmaceuticals is recalling DULoxetine 30mg 90-count bottles because they contain a nitrosamine impurity that could be harmful. This recall is for prescription-only medication sold between January 2025 and April 2025. Read more at govinfonow.com/recall/32389-pd-rx-duloxetine-30mg-90-count-recall-nitrosamine-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32389-pd-rx-duloxetine-30mg-90-count-recall-nitrosamine-impurity-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0163-2025
Cite this page
“PD-Rx DULoxetine 30mg 90-count recall: Nitrosamine impurity risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32389-pd-rx-duloxetine-30mg-90-count-recall-nitrosamine-impurity-risk. Based on FDA recall #D-0163-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0163-2025%22&limit=1).
Why it’s dangerous
The medication contains a nitrosamine impurity (NDSRI) that exceeds safety limits. This impurity could potentially cause health issues, though the exact risk level is not clearly stated in the recall.
Who’s affected
Prescription users of DULoxetine 30mg 90-count bottles with specific lot numbers and expiration dates. Those who have taken the medication since January 2025 are most at risk.
How to tell if you have this one
Check for lot numbers I24E77, A24E49, J23C50, J23C97, L23B39, L23E98 with expiration dates of April 30, 2025 or January 31, 2025. The product is a prescription-only 30mg DULoxetine 90-count bottle.
- Brand
PD-Rx Pharmaceuticals- Category
Drug
What to do — step by step
Contact Manufacturer
Reach out to PD-Rx Pharmaceuticals for specific guidance on handling the recalled medication.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “Distributed within US: FL, MS, WI” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Mississippi, Wisconsin.
Recall timeline
FDA terminated this recall 4 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0163-2025 (December 4, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0163-2025 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.