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.
CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
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.
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.
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.
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.
Reach out to PD-Rx Pharmaceuticals for specific guidance on handling the recalled medication.
The recall states the medication contains a nitrosamine impurity above safety limits, but the exact health risk is not clearly described.
The recall does not specify a remedy, so contact PD-Rx Pharmaceuticals directly for instructions.
Lot numbers I24E77, A24E49, J23C50, J23C97, L23B39, L23E98 with expiration dates of April 30, 2025 or January 31, 2025.
We’ve drafted a message you can send PD-Rx Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0163-2025 — PD-Rx Pharmaceuticals PD-Rx Pharmaceuticals Hello, I own a PD-Rx Pharmaceuticals that is covered by recall D-0163-2025 from PD-Rx Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
