CLASS III Drug recall · Reported 2 Jan 2019 · FDA Enforcement Report
Temozolomide Capsules, 180 mg recalled by Amerigen Pharmaceuticals
Amerigen Pharmaceuticals is recalling Temozolomide Capsules, 180 mg. The recall was initiated on 20 Dec 2018 and the FDA has classified it as Class III.
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-0345-2019
- FDA event ID
- 81858
- Recalling firm
- Amerigen Pharmaceuticals, Lyndhurst, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Dec 2018
- FDA classified
- 26 Dec 2018
- Reported
- 2 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 20 Dec 2018 | Recall initiated by company | |
| 26 Dec 2018 | Classified by FDA | +6 days |
| 2 Jan 2019 | Published in enforcement report | +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
Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ ---- NDC 43975-256-14
Where it was distributed
Product was distributed to 4 wholesalers and 2 retail accounts who may have further distributed the products.
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot # 18E031, exp 05/2020
Where was it sold?
Product was distributed to 4 wholesalers and 2 retail accounts who may have further distributed the products.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
Other products in this recall event
1 other product · FDA event 81858| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Temozolomide Capsules, 20 mg recalled by Amerigen Pharmaceuticals | Amerigen Pharmaceuticals | Potency & Assay | NJ |
More recalls from Amerigen Pharmaceuticals
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Temozolomide Capsules, 5 mg recalled by Amerigen Pharmaceuticals | Amerigen Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Temozolomide Capsules, 20 mg recalled by Amerigen Pharmaceuticals | Amerigen Pharmaceuticals | Potency & Assay | NJ |
| Drug | CLASS III | Temozolomide capsules, 20 mg recalled by Amerigen Pharmaceuticals | Amerigen Pharmaceuticals | Potency & Assay | Nationwide |
Other Temozolomide recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Product label: Temozolomide Capsules, 5mg recalledTemozolomide | Rising Pharma Holding | Potency & Assay | Nationwide |
| Drug | CLASS II | Temozolomide Capsules, 5 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Temozolomide Capsules, 140 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Temozolomide Capsules, 250 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Temozolomide Capsules, 20 mg recalled by Deva Holding AS - CerkezkoyTemozolomide | Deva Holding AS - Cerkezkoy Subesi | Manufacturing (CGMP) Deviations | Nationwide |