Torrent Pharma Inc. 2025-06-11 Health serious FDA
Health · FDA · Recall #FDA-D-0456-2025
Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT… Recall
Issued June 11, 2025 · Torrent Pharma Inc.
In June 2025, Torrent Pharma Inc. recalled the Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
What you should do
- 1 Stop using Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Torrent Pharma Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Torrent Pharma Inc.
- Category
- Health
- Recall date
- June 11, 2025
- Units affected
- Not reported
- Sold at
- U.S. Nationwide.
- Recall number
- FDA-D-0456-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Torrent Pharma Inc. has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.