CLASS II Drug recall · Reported 15 Oct 2014 · FDA Enforcement Report
Tarceva (erlotinib) Tablets, 150 mg recalled by Astellas Pharma US
Astellas Pharma US is recalling Tarceva (erlotinib) Tablets, 150 mg, distributed nationwide in the US. The recall was initiated on 15 Sep 2014 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-0008-2015
- FDA event ID
- 69246
- Recalling firm
- Astellas Pharma US, Northbrook, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Sep 2014
- FDA classified
- 7 Oct 2014
- Reported
- 15 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 15 Sep 2014 | Recall initiated by company | |
| 7 Oct 2014 | Classified by FDA | +22 days |
| 15 Oct 2014 | 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 Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month 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
Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. Seymour, IN 47274 NDC 50242-064-01
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: The product did not meet the acceptance criteria for the dissolution test during the 24 month routine stability testing.
Which lots are affected?
Lot 66482CW, Exp 04/16
Where was it sold?
Nationwide
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 Astellas Pharma US
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Astagraf XL (tacrolimus extended-release capsules) 0.5 mg recalledAstagraf Xl | Astellas Pharma US | Packaging Defects | Nationwide |
| Drug | CLASS I | Prograf (tacrolimus) capsules, USP, 0.5 mg recalledPrograf | Astellas Pharma US | Packaging Defects | Nationwide |
| Drug | CLASS II | Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial recalled | Astellas Pharma US | Other | Nationwide |
| Drug | CLASS II | AmBisome (amphotericin B) liposome for injection, 50mg vial recalled | Astellas Pharma US | Sterility | Nationwide |