Ben Venue Recalls Leucovorin Calcium Injection Due to Particulate Matter
Ben Venue Laboratories is recalling 226,010 vials of Leucovorin Calcium Injection due to the presence of visible crystalline particulates.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves particulate matter without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Ben Venue Laboratories Inc. is recalling 226,010 vials of Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL. The recall was initiated because of the presence of visible crystalline particulates and the discovery of crystalline particulate in a retain sample.
The affected product is prescription-only and was distributed nationwide and in Puerto Rico. The recall covers specific lots with expiration dates ranging from November 2012 to June 2013, including NDC numbers 55390-009-01 and 55390-826-01.
Healthcare providers and patients should stop using the affected vials and contact Ben Venue Laboratories for further instructions.
The recalled product
- Product
- Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, Manufactured by: Ben Venue Labs, Inc., Bedford, OH 44146, NDC# 55390-009-01(Bedford); NDC# 55390-826-01(Novaplus)
- Manufacturer
- Ben Venue Laboratories Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 226,010
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 #
- 2017619 (Bedford)
- Mfr Item # 0967-57-2017619
- NDC
- 55390-009-01
- Exp. Date 11/2012
- Lot# 2017620
- Exp. Date 1/2013
- NDC #55390-009-01
- 2017621 (Bedford)
- Mfr Item # 0967-57-2017621
- Exp Date 01/2013
- Lot #2038374
- exp. 2/2013
- Lot #2038374A
- 2038375 (Bedford)
- Mfr Item # 0967-57-2038375
- Exp Date 03/2013
- 2065418 (Bedford)
- Mfr Item # 0967-57-2065418
Distribution
Related recalls
Same manufacturer · Ben Venue Laboratories Inc
See all →- SevereBen Venue Recalls Cytarabine for Injection Due to Sterility Concerns
FDA (Drugs) · 2014-08-27
- CriticalBen Venue Recalls Acetylcysteine Solution Due to Glass Particulate
FDA (Drugs) · 2014-05-28
- SevereBen Venue Recalls Vecuronium Bromide Injection Due to Particulate Matter
FDA (Drugs) · 2012-10-03
- ModerateBen Venue Recalls Octreotide Acetate Injection Due to Potential Low Fill Volume
FDA (Drugs) · 2012-06-20
- ModerateBen Venue Recalls Midazolam HCl Injection Due to Potential Low Fill Volume
FDA (Drugs) · 2012-06-20
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