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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 10,425
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 manufacturer · Teva Pharmaceuticals USA
See all →- ModerateDoxylamine Succinate and Pyridoxine Hydrochloride Tablets Recalled for Failed Dissolution
FDA (Drugs) · 2022-02-09
- LowPrescription Drug Recall: Mimvey Mislabeling by Teva Pharmaceuticals
FDA (Drugs) · 2022-02-09
- ModerateTretinoin Capsules 10 mg Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2022-02-09
- LowMimvey Estradiol/Norethindrone Prescription Drug Mislabeling Recall
FDA (Drugs) · 2022-02-09
- ModerateBrinzolamide Ophthalmic Suspension recalled for defective container caps
FDA (Drugs) · 2022-01-26
Same hazard · particulate contamination
See all →- CriticalCardiovascular Procedure Kits Recalled Due to Particulate in Fluid Path
FDA (Devices) · 2026-08-05
- HighLidocaine Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
- ModerateFDA Recalls Xylocaine Injections Due to Hair Contamination
FDA (Drugs) · 2026-07-29
- SevereMedline Medical Convenience Kits with Namic Manifold Fluid Contamination
FDA (Devices) · 2026-05-20
- SevereMedline Medical Convenience Kits with Namic Manifold recalled
FDA (Devices) · 2026-05-20
Similar recalls
- SevereTeva Recalls Amikacin Sulfate Injection Due to Glass Particulate Matter
FDA (Drugs) · 2016-06-01
- HighTeva Recalls Metoclopramide Injection Due to Chemical Contamination
FDA (Drugs) · 2021-03-10
- CriticalTeva Recalls ADRUCIL Fluorouracil Injection Due to Particulate Matter
FDA (Drugs) · 2015-09-02
- SevereFDA Recalls IDArubicin Injection for Particulate Matter Contamination
FDA (Drugs) · 2022-04-20
- SevereTeva Recalls Toposar Etoposide Injection Due to Sterility Assurance Issues
FDA (Drugs) · 2021-03-03
- SevereTeva Norepinephrine Bitartrate Injection Recalled for Sterility Assurance
FDA (Drugs) · 2021-08-25