CLASS III Drug recall · Reported 27 Feb 2019 · FDA Enforcement Report
Temozolomide Capsules, 5 mg recalled by Amerigen Pharmaceuticals
Amerigen Pharmaceuticals is recalling Temozolomide Capsules, 5 mg, distributed nationwide in the US. The recall was initiated on 19 Feb 2019 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-0516-2019
- FDA event ID
- 82158
- Recalling firm
- Amerigen Pharmaceuticals, Lyndhurst, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Feb 2019
- FDA classified
- 20 Feb 2019
- Reported
- 27 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 19 Feb 2019 | Recall initiated by company | |
| 20 Feb 2019 | Classified by FDA | +1 day |
| 27 Feb 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, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count bottle (NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071
Where it was distributed
Product was distributed to 4 wholesalers/distributors and 1 retail account who may have further distribute the product throughout the United States.
Questions about this recall
Why was it recalled?
Failed dissolution specifications
Which lots are affected?
Lot #: a) 18J043A, Exp 09/30/2020, b) 18J043B, Exp 09/30/2020
Where was it sold?
Product was distributed to 4 wholesalers/distributors and 1 retail account who may have further distribute the product throughout the United States.
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.
More recalls from Amerigen Pharmaceuticals
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Temozolomide Capsules, 20 mg recalled by Amerigen Pharmaceuticals | Amerigen Pharmaceuticals | Potency & Assay | NJ |
| Drug | CLASS III | Temozolomide Capsules, 180 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 |