CLASS II Drug recall · Reported 25 Sep 2019 · FDA Enforcement Report
Anagrelide Capsules, USP, 5 mg recalled by Torrent Pharma
Torrent Pharma is recalling Anagrelide Capsules, USP, 5 mg, distributed nationwide in the US. The recall was initiated on 6 Sep 2019 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-1862-2019
- FDA event ID
- 83733
- Recalling firm
- Torrent Pharma, Basking Ridge, NJ
- Brand
- Anagrelide
- Manufacturer
- Torrent Pharmaceuticals Limited
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Sep 2019
- FDA classified
- 16 Sep 2019
- Reported
- 25 Sep 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 6 Sep 2019 | Recall initiated by company | |
| 16 Sep 2019 | Classified by FDA | +10 days |
| 25 Sep 2019 | 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
Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
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
Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-453-01.
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Is Anagrelide Capsules, USP, 5 mg recalled?
Yes. Torrent Pharma recalled Anagrelide Capsules, USP, 5 mg on 6 Sep 2019. The recall is Class II and its status is Terminated. Recall number D-1862-2019.
Why was it recalled?
Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
Which lots are affected?
Lot #: BFE2E003, Exp 08/31/2020
Where was it sold?
Nationwide in the USA 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 Anagrelide recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Anagrelide Capsules USP, 5 mg recalled by Teva Pharmaceuticals USA | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS I | Anagrelide Capsules, USP 1 mg recalled by Torrent PharmaAnagrelide | Torrent Pharma | Potency & Assay | Nationwide |