Fluoxetine Tablets recall
FDA recall D-0456-2025 · initiated May 27, 2025
Torrent Pharma Inc. recalled Fluoxetine Tablets in May 2025 — an FDA Class II recall (D-0456-2025) because CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 972 Cartons
Details
- Product
- Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Carton); 13668-473-70 (Blister)
- Recalling company
- Torrent Pharms LLC
- Classification
- Class II
- Status
- Completed
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide.
- Initiated
- May 27, 2025
- FDA report date
- Jun 11, 2025
Frequently asked
- Was Fluoxetine Tablets recalled?
- Torrent Pharma Inc. recalled Fluoxetine Tablets in May 2025 — an FDA Class II recall (D-0456-2025) because CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Fluoxetine Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0456-2025 was: CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
- Is a recalled Fluoxetine Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Fluoxetine Tablets are affected?
- Distributed: U.S. Nationwide.. The recall covers these lots — Lot# BDX6K001; Exp. Date: 06/30/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0456-2025.