FDA Recalls Temozolomide Capsules Due to Cross-Contamination Risk
Deva Holding AS is recalling Temozolomide Capsules because manufacturing deviations allowed for possible cross-contamination with beta-lactam products.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential cross-contamination with beta-lactams, which poses a significant risk of allergic reactions in sensitive patients, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Temozolomide Capsules, 180 mg, manufactured by Deva Holding AS and distributed by Ascend Laboratories, LLC. The recall affects 5-count and 14-count bottles of the prescription medication, which are distributed nationwide in the USA.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the product was manufactured in a manner that did not prevent possible cross-contamination with beta-lactam products. Temozolomide is an alkylating drug used for the treatment of certain cancers.
Patients and healthcare providers should stop using the affected lots and contact their healthcare provider for guidance on alternative treatment options. The specific lot numbers and expiration dates are listed in the official FDA recall notice D-1512-2019.
The recalled product
- Product
- TEMOZOLOMIDE (TEMOZOLOMIDE)
- Brand
- TEMOZOLOMIDE
- Manufacturer
- Deva Holding AS - Cerkezkoy Subesi
- Category
- Drug — Antineoplastic
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 (20)
- Lot #: a) A061858
- A061857
- A061856
- A061860
- A061859
- Exp 07/31/2019
- A069401
- A069402
- Exp 05/31/2020
- A071978
- Exp 09/30/2020
- A076736
- A076735
- Exp 04/30/2021
- b) A062031. A062015
- A062014
- A062050
- A062038
- A069521
- A069470
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
- HighTemozolomide Capsules Recalled for Potential Cross-Contamination with Beta-Lactam Products
FDA (Drugs) · 2019-07-31
- ModerateFDA Recalls Temozolomide Capsules Due to Cross-Contamination Risk
FDA (Drugs) · 2019-07-31
- ModerateTemozolomide 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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