Amerigen Recalls Temozolomide Capsules Due to Dissolution Failures
Amerigen Pharmaceuticals is recalling specific lots of Temozolomide Capsules because they failed to meet dissolution specifications.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences, and the hazard involves a failure to meet specifications rather than a direct physical injury risk.
Plain-English summary
Amerigen Pharmaceuticals Inc. is recalling 3,552 bottles of Temozolomide Capsules, 20 mg. The affected products are packaged in 5-count and 14-count bottles and were manufactured by Stason Pharmaceuticals, Inc. The specific lots involved are 18B005 A and 18B005 B, with an expiration date of 02/2020.
The recall was initiated because the product failed to meet dissolution specifications. This means the capsules may not release the medication in the body as intended, potentially affecting the drug's effectiveness.
The product was distributed to four wholesalers and two retail accounts, which may have further distributed the items. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if found.
The recalled product
- Product
- Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ
- Manufacturer
- Amerigen Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 3,552
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)
- a) Lot # 18B005 A and b) Lot # 18B005 B
- exp 02/2020
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
- LowAmerigen Recalls Temozolomide Capsules for Failed Dissolution Specifications
FDA (Drugs) · 2019-01-02
- LowAmerigen Recalls Temozolomide Capsules Due to Dissolution Failures
FDA (Drugs) · 2018-10-24
Same hazard · dissolution failure
See all →- ModerateApotex Recalls Paroxetine Hydrochloride Extended-Release Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateAjanta Pharma Recalls Ranolazine Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateMylan Recalls Mycophenolate Mofetil Injection Due to Dissolution Failures
FDA (Drugs) · 2026-09-09
- ModerateApotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
- ModerateMylan Recalls Acamprosate Calcium Tablets Due to Dissolution Failure
FDA (Drugs) · 2026-08-26
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
- HighTemozolomide capsules recalled after failing impurities and degradation specifications
FDA (Drugs) · 2026-03-11
- ModerateMylan Recalls Temozolomide Capsules Due to Broken Capsules and Loose Powder
FDA (Drugs) · 2017-02-01
- ModerateUpsher-Smith Recalls Bexarotene Capsules Due to Dissolution Failures
FDA (Drugs) · 2019-08-28