Teva Recalls ADRUCIL Fluorouracil Injection Due to Particulate Matter
Teva Pharmaceuticals USA is recalling ADRUCIL (fluorouracil injection) vials due to the presence of silicone rubber and fluorouracil crystals in the solution.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Teva Pharmaceuticals USA is recalling 6,001 vials of ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL), manufactured by Teva Parenteral Medicines, Inc. The recall involves glass vials sold in cartons of five, with NDC numbers 073-3019-11 and 0703-3019-12. The affected lots are 31317857B, 31317859B, 31317920B, 31317957B, 31318136B, and 31318138B, with expiration dates ranging from August 2015 to December 2015.
The recall was initiated because particulate matter, specifically silicone rubber and fluorouracil crystals, was found floating in the solution. The product was distributed nationwide.
Healthcare providers and patients should stop using the affected vials and contact Teva Pharmaceuticals USA for further instructions or to arrange for a return or replacement.
The recalled product
- Product
- ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carton, manufactured by Teva Parenteral Medicines, Inc., Irvine, CA. NDC 073-3019-11 (individual vial), NDC 0703-3019-12 (carton of five).
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable
- Affected units
- 6,001
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 (7)
- Lot # 31317857B
- Exp 08/15 31317859B
- Exp 12/15 31317920B
- Exp 12/15 31317957B
- Exp 12/15 31318136B
- Exp 12/15 31318138B
- Exp 12/15
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 matter
See all →- SevereACTHAR Gel Recalled for Presence of Glass and Stopper Particulate Matter
FDA (Drugs) · 2026-09-02
- SevereB. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
- CriticalAmerican Regent Recalls Papaverine Hydrochloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Nitroglycerin Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Cyanocobalamin Injections Due to Particulate Matter
FDA (Drugs) · 2026-08-26