Amerigen Recalls Temozolomide Capsules for Failed Dissolution Specifications
Amerigen Pharmaceuticals is recalling Temozolomide Capsules, 180 mg, due to failed dissolution specifications. The FDA classified this as a Class III recall.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Amerigen Pharmaceuticals Inc. is recalling Temozolomide Capsules, 180 mg, packaged in 14-count bottles. The product is manufactured by Stason Pharmaceuticals, Inc., and distributed by Amerigen Pharmaceuticals. The specific lot number is 18E031, with an expiration date of 05/2020. The recall involves 771 bottles.
The recall was initiated because the product failed dissolution specifications. Dissolution tests ensure that the medication releases the active ingredient at the correct rate; failure to meet these specifications may result in the medication not working as intended. The FDA has classified this recall as Class III, which indicates that the product is not likely to cause adverse health consequences.
The product was distributed to four wholesalers and two retail accounts, which may have further distributed the medication. Patients and healthcare providers should check their inventory for the specific NDC 43975-256-14 and Lot # 18E031. If the product is found, it should be returned to the pharmacy or contact Amerigen Pharmaceuticals for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Amerigen Pharmaceuticals Inc.
- Category
- Drug — Oncology
- Hazard
- Affected units
- 771
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 18E031
- exp 05/2020
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Amerigen Pharmaceuticals Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Amerigen Pharmaceuticals Inc.
See all →- LowAmerigen Recalls Temozolomide Capsules Due to Dissolution Failures
FDA (Drugs) · 2019-02-27
- ModerateAmerigen Recalls Temozolomide Capsules Due to Dissolution Failures
FDA (Drugs) · 2019-01-02
- LowAmerigen Recalls Temozolomide Capsules Due to Dissolution Failures
FDA (Drugs) · 2018-10-24
Same hazard · failed dissolution
See all →- ModerateInventia Recalls Chlorthalidone Tablets Due to Failed Dissolution Specifications
FDA (Drugs) · 2026-09-23
- ModerateMylan Recalls Prasugrel Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-09
- SevereGolden State Medical Supply Recalls Prasugrel Tablets for Failed Dissolution
FDA (Drugs) · 2026-09-09
- ModerateNovartis Recalls Diovan Valsartan Tablets Due to Failed Dissolution Specifications
FDA (Drugs) · 2026-08-19
- LowSupernus Recalls Trokendi XR Capsules for Failed Dissolution Specifications
FDA (Drugs) · 2026-07-29
Similar recalls
- LowAmerigen Recalls Temozolomide Capsules Due to Dissolution Failures
FDA (Drugs) · 2019-02-27
- ModerateMacleods Pharma Recalls Tamsulosin Hydrochloride Capsules for Dissolution Failures
FDA (Drugs) · 2019-08-21
- HighTretinoin Capsules Recalled Nationwide for Failed Dissolution Specifications
FDA (Drugs) · 2022-06-29
- ModeratePrescription Drug Tizanidine Tablets Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2023-07-12
- HighTemozolomide capsules recalled after failing impurities and degradation specifications
FDA (Drugs) · 2026-03-11
- ModerateTretinoin Capsules 10 mg Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2022-02-09