CLASS I Drug recall · Reported 8 Jun 2022 · FDA Enforcement Report
Anagrelide Capsules USP, 5 mg recalled by Teva Pharmaceuticals USA
Teva Pharmaceuticals USA is recalling Anagrelide Capsules USP, 5 mg, distributed nationwide in the US. The recall was initiated on 11 May 2022 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-0992-2022
- FDA event ID
- 90182
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 11 May 2022
- FDA classified
- 8 Jun 2022
- Reported
- 8 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 11 May 2022 | Recall initiated by company | |
| 8 Jun 2022 | Classified by FDA | +28 days |
| 8 Jun 2022 | Published in enforcement report | +0 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- Low Out-Of-Specification results obtained during 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 bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60.
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Is Anagrelide Capsules USP, 5 mg recalled?
Yes. Teva Pharmaceuticals USA recalled Anagrelide Capsules USP, 5 mg on 11 May 2022. The recall is Class I and its status is Terminated. Recall number D-0992-2022.
Why was it recalled?
Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
Which lots are affected?
Lot # GD01090, Exp 05/2022
Where was it sold?
Distributed Nationwide in the USA
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 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 Teva Pharmaceuticals USA
All 84| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
| Drug | CLASS II | Isotretinoin Capsules, USP, 40 mg Prescription Pacs recalledIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
Other Anagrelide recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Anagrelide Capsules, USP 1 mg recalled by Torrent PharmaAnagrelide | Torrent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Anagrelide Capsules, USP, 5 mg recalled by Torrent PharmaAnagrelide | Torrent Pharma | Potency & Assay | Nationwide |