Topotecan Injection recalled for particulate contamination
Teva Pharmaceuticals is recalling Topotecan Injection 4 mg/4mL single-dose vials due to the presence of particulate matter, including glass, silicone, and cotton fiber, found inside affected vials.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall. Per the rubric, FDA Class I recalls are never scored below 4. Although no illnesses or injuries are reported in the source text, the presence of foreign particulate matter (glass, silicone, cotton fiber) in an injectable cancer medication represents a significant direct risk of harm to patients.
Plain-English summary
Teva Pharmaceuticals USA is recalling Topotecan Injection 4 mg/4mL (1 mg/mL) single-dose vials distributed nationwide in the USA. The recall was initiated after a complaint reported a glass particle observed inside a vial. Upon return and analysis by Teva, two additional particulates were found and identified: one grey silicone particle and one translucent, colorless cotton fiber.
Topotecan is an injectable cancer medication. The presence of particulate matter in an injection vial poses a direct risk of harm to patients who receive the medication.
The affected product is Topotecan Injection 4 mg/4mL (1 mg/mL) manufactured by Teva Pharmaceuticals USA, Inc. in North Wales, PA, Lot #31328962B with expiration date 04/2022 (Carton NDC# 0703-4714-01, Vial NDC# 0703-4714-71). Approximately 10,425 vials were distributed.
Patients and healthcare providers who have this product should stop use and contact Teva Pharmaceuticals or their healthcare provider immediately for guidance on replacement product or alternative treatment options.
The recalled product
- Product
- Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc. North Whales, PA 19454, Carton NDC# 0703-4714-01, Vial NDC# 0703-4714-71
- Manufacturer
- Teva Pharmaceuticals USA
- Hazard
- particulate-contamination
- foreign-matter
- glass-fragment
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 # 31328962B
- exp. date 04/2022
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-06-17
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- SevereCIMZIA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-05-27