CLASS I Drug recall · Reported 9 Dec 2020 · FDA Enforcement Report
Anagrelide Capsules, USP 1 mg recalled by Torrent Pharma
Torrent Pharma is recalling Anagrelide Capsules, USP 1 mg, distributed nationwide in the US. The recall was initiated on 25 Nov 2020 and the FDA has classified it as Class I.
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-0166-2021
- FDA event ID
- 86878
- Recalling firm
- Torrent Pharma, Levittown, PA
- Brand
- Anagrelide
- Manufacturer
- Torrent Pharmaceuticals Limited
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 25 Nov 2020
- FDA classified
- 16 Dec 2020
- Reported
- 9 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 25 Nov 2020 | Recall initiated by company | |
| 9 Dec 2020 | Published in enforcement report | +14 days |
| 16 Dec 2020 | Classified by FDA | +7 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
Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920 NDC 13668-462-01
Where it was distributed
Nationwide USA and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Batch BFD1G001, exp 12/2021
Where was it sold?
Nationwide 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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 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 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Anagrelide Capsules USP, 0.5 mg recalled by Teva Pharmaceuticals USA | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Anagrelide Capsules, USP, 0.5 mg recalled by Torrent PharmaAnagrelide | Torrent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Anagrelide HCL, Capsule, 0.5 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |