Reported Jun 11, 2025 · Completed
Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721…
Torrent Pharma Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Torrent Pharma Inc. · 106 Allen Rd Ste 305 · Basking Ridge, NJ · 07920-3851
Is this the product you have?
- Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only
- Manufactured byTORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA
- Manufactured forTORRENT PHARMA INC., Basking Ridge, NJ 07920
- NDC13668-473-30
- Lot codes and dates
Lot# BDX6K001Exp. Date 06/30/2025
- Amount recalled
- 3672 Bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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