CLASS II Drug recall · Reported 19 Jul 2023 · FDA Enforcement Report
Sunitinib Malate Capsules, 12.5 mg recalled by Teva Pharmaceuticals USA
Teva Pharmaceuticals USA is recalling Sunitinib Malate Capsules, 12.5 mg, distributed nationwide in the US. The recall was initiated on 5 Jul 2023 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-0913-2023
- FDA event ID
- 92636
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Brand
- Sunitinib Malate
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jul 2023
- FDA classified
- 11 Jul 2023
- Reported
- 19 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 5 Jul 2023 | Recall initiated by company | |
| 11 Jul 2023 | Classified by FDA | +6 days |
| 19 Jul 2023 | Published in enforcement report | +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 Moisture Limits: Water (moisture) content above the approved product specifications.
Product as listed by the FDA
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28
Where it was distributed
Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.
Questions about this recall
Why was it recalled?
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
Which lots are affected?
Lot # 100037220, Exp 10/2024
Where was it sold?
Product was distributed to 3 wholesalers/distributors who further distributed the product 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 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 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 Teva Pharmaceuticals USA
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|---|---|---|---|---|---|
| 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 Sunitinib Malate recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sunitinib Malate Capsules, 25 mg recalled by AvKARESunitinib Malate | AvKARE | Packaging Defects | Nationwide |
| Drug | CLASS II | Sunitinib Malate Capsules, 12.5 mg recalled by AvKARESunitinib Malate | AvKARE | Packaging Defects | Nationwide |