CLASS II Drug recall · Reported 11 Jun 2025 · FDA Enforcement Report
Fluoxetine Tablets, USP, 20 mg Carton ( Unit-dose) recalled
Torrent Pharma is recalling Fluoxetine Tablets, USP, 20 mg Carton ( Unit-dose), distributed nationwide in the US. The recall was initiated on 27 May 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0456-2025
- FDA event ID
- 96983
- Recalling firm
- Torrent Pharma, Basking Ridge, NJ
- Brand
- Fluoxetine
- Manufacturer
- Torrent Pharmaceuticals Limited
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 27 May 2025
- FDA classified
- 2 Jun 2025
- Reported
- 11 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Nitrosamine Impurity
- Drug class
- Antidepressants
Timeline
| 27 May 2025 | Recall initiated by company | |
| 2 Jun 2025 | Classified by FDA | +6 days |
| 11 Jun 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
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)
Where it was distributed
U.S. Nationwide.
Questions about this recall
Is Fluoxetine Tablets, USP, 20 mg Carton ( Unit-dose) recalled?
Yes. Torrent Pharma recalled Fluoxetine Tablets, USP, 20 mg Carton ( Unit-dose) on 27 May 2025. The recall is Class II and its status is Completed. Recall number D-0456-2025.
Why was it recalled?
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Which lots are affected?
Lot# BDX6K001; Exp. Date: 06/30/2025
Where was it sold?
U.S. Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Torrent Pharma
All 84| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fluoxetine Tablets, USP, 20 mg recalled by Torrent PharmaFluoxetine | Torrent Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg recalledPantoprazole Sodium | Torrent Pharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Carbamazepine Tablets, USP 200 mg recalled by Torrent PharmaCarbamazepine | Torrent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS III | Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg recalled | Torrent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS I | Anagrelide Capsules, USP 1 mg recalled by Torrent PharmaAnagrelide | Torrent Pharma | Potency & Assay | Nationwide |
Other Fluoxetine recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fluoxetine Tablets, USP, 20 mg recalled by Torrent PharmaFluoxetine | Torrent Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS III | Fluoxetine Tablets USP, 10 mg recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluoxetine Capsules USP, 10 mg recalled by Teva Pharmaceuticals UFluoxetine | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluoxetine Capsules USP, 20 mg recalled by Teva Pharmaceuticals UFluoxetine | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS III | Fluoxetine Capsules USP, 20 mg recalled by Sandoz Incorporated | Sandoz Incorporated | Other | AZ |