Temozolomide Capsules Recalled for Potential Cross-Contamination with Beta-Lactam Products
Deva Holding AS is recalling Temozolomide capsules due to manufacturing deviations that allowed possible cross-contamination with beta-lactam products.
What this means for you
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 II due to a manufacturing deviation (cross-contamination risk) without reported illnesses or injuries, fitting the 'voluntary precautionary recalls' or 'low-risk contamination' criteria for a Moderate severity score.
Plain-English summary
Deva Holding AS is recalling Temozolomide Capsules, 20 mg, in 5-count and 14-count bottles. The recall was initiated because the product was manufactured under conditions that did not prevent possible cross-contamination with beta-lactam products.
The affected lots include A061688, A061687, A061685, A068994, A071853, A061794, A061833, A061822, A069115, A071855, and A071854. These products were distributed nationwide in the USA by Ascend Laboratories, LLC.
Patients and healthcare providers should stop using the recalled Temozolomide capsules and contact their healthcare provider for guidance on alternative treatment options. The FDA has classified this recall as Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- TEMOZOLOMIDE (TEMOZOLOMIDE)
- Brand
- TEMOZOLOMIDE
- Manufacturer
- Deva Holding AS - Cerkezkoy Subesi
- Category
- Drug — Prescription Medication
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 (15)
- Lot #: a) A061688
- A061687
- A061685
- Exp 07/31/2019
- A068994
- Exp 04/30/2020
- A071853
- Exp 09/30/20
- b) A061794
- A061833
- A061822
- A069115
- A071855
- A071854
- Exp 09/30/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Deva Holding AS - Cerkezkoy Subesi 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 6 products in this recall →Related recalls
Same brand · TEMOZOLOMIDE
- HighTemozolomide capsules recalled after failing impurities and degradation specifications
FDA (Drugs) · 2026-03-11
- ModerateFDA Recalls Temozolomide Capsules Due to Cross-Contamination Risk
FDA (Drugs) · 2019-07-31
- HighFDA Recalls Temozolomide Capsules Due to Cross-Contamination Risk
FDA (Drugs) · 2019-07-31
- HighTemozolomide Capsules Recalled for Potential Cross-Contamination with Beta-Lactam Products
FDA (Drugs) · 2019-07-31
- HighTemozolomide Capsules Recalled for Potential Cross-Contamination with Beta-Lactam Products
FDA (Drugs) · 2019-07-31
Same manufacturer · Deva Holding AS - Cerkezkoy Subesi
See all →- HighTemozolomide Capsules Recalled for Potential Cross-Contamination with Beta-Lactam Products
FDA (Drugs) · 2019-07-31
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