CLASS II Drug recall · Reported 10 Jun 2020 · FDA Enforcement Report
Carbamazepine Tablets, USP 200 mg recalled by Torrent Pharma
Torrent Pharma is recalling Carbamazepine Tablets, USP 200 mg, distributed nationwide in the US. The recall was initiated on 11 May 2020 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-1317-2020
- FDA event ID
- 85644
- Recalling firm
- Torrent Pharma, Basking Ridge, NJ
- Brand
- Carbamazepine
- Manufacturer
- Torrent Pharmaceuticals Limited
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 May 2020
- FDA classified
- 18 Jun 2020
- Reported
- 10 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Seizure Medication
Timeline
| 11 May 2020 | Recall initiated by company | |
| 10 Jun 2020 | Published in enforcement report | +30 days |
| 18 Jun 2020 | Classified by FDA | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd, Bharuch 392130, India; Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-268-05
Where it was distributed
USA Nationwide and Puerto Rico
Questions about this recall
Is Carbamazepine Tablets, USP 200 mg recalled?
Yes. Torrent Pharma recalled Carbamazepine Tablets, USP 200 mg on 11 May 2020. The recall is Class II and its status is Terminated. Recall number D-1317-2020.
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot #: 4FF4F001, Exp 1/2023
Where was it sold?
USA Nationwide and Puerto Rico
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 | Fluoxetine Tablets, USP, 20 mg Carton ( Unit-dose) recalledFluoxetine | 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 |
Other Carbamazepine recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalledCarbamazepine | Golden State Medical Supply | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Carbamazepine Extended-Release Tablets recalledCarbamazepine | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS II | Carbamazepine Tablets, USP 200 mg recalled by Torrent PharmaCarbamazepine | Torrent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Carbamazepine 200mg Tablets, USP, 200 mg Unit Dose recalledCarbamazepine | The Harvard Drug Group | Potency & Assay | NC |