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.
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. The hazard involves potential cross-contamination with beta-lactams, which poses a risk of allergic reaction (harm) to susceptible patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Deva Holding AS is recalling Temozolomide Capsules, 140 mg, in 5-count and 14-count bottles. The recall involves specific lots distributed nationwide in the United States by Ascend Laboratories, LLC. The product is a prescription-only medication manufactured in Turkey.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturing process did not prevent possible cross-contamination with beta-lactam products. Beta-lactams are a class of antibiotics to which some patients may have severe allergic reactions.
Patients who have received or are currently using the affected Temozolomide capsules should contact their healthcare provider for guidance. The affected lots are identified by specific lot numbers and expiration dates listed in the official recall notice.
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 (18)
- Lot #: a) A063581
- A063462
- A063460
- Exp 09/30/2019
- A063582
- Exp 10/31/2019
- A069129
- Exp 05/31/2020
- A071801
- Exp 09/30/2020
- b) A063639
- A063624
- A063609
- A063657
- A069366
- A071817
- A071819
- A071818
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
- 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
Same manufacturer · Deva Holding AS - Cerkezkoy Subesi
See all →- ModerateTemozolomide Capsules Recalled for Potential Cross-Contamination with Beta-Lactam Products
FDA (Drugs) · 2019-07-31
Same hazard · cross contamination
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