Sanofi-aventis Recalls Eloxatin Injection Due to Manufacturing Issues
Sanofi-aventis is recalling Eloxatin (oxaliplatin) injection vials because the contract manufacturer had significant Good Manufacturing Practice issues.
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 2/5 (Moderate).
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. The source text cites CGMP deviations but does not report specific illnesses, injuries, or deaths, fitting the criteria for a moderate severity recall involving potential quality issues without confirmed harm.
Plain-English summary
Sanofi-aventis US, Inc. is recalling 387,738 vials of Eloxatin (oxaliplatin injection) 5 mg/mL, 100 mg, Rx only. The product was distributed nationwide. The recall involves specific lot numbers and expiration dates ranging from February 2012 to January 2014.
The recall was initiated because Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency. The inspection revealed significant issues in Good Manufacturing Practices (CGMP Deviations).
Healthcare providers and patients should stop using the affected vials and contact Sanofi-aventis for further instructions. The affected lots include AD21, AD22, AE24, AE25, AF55, AE26, AF03, AF04, AF21, BL19B, CB11B, CB102B, CB12B, CA01B, BH07, BH08, BH09, and CC109B.
The recalled product
- Product
- Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0591-20
- Manufacturer
- sanofi-aventis US, Inc.
- Category
- Drug — Antineoplastic
- Hazard
- Affected units
- 387,738
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by sanofi-aventis US, Inc. 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 2 products in this recall →Related recalls
Same manufacturer · sanofi-aventis US, Inc.
See all →- ModerateSanofi-Aventis Recalls Diamigo Diabetes App Due to Unintended Global Access
FDA (Devices) · 2013-01-02
- ModerateSanofi Recalls Eloxatin Injection Due to Manufacturing Practice Deviations
FDA (Drugs) · 2012-07-11
Same hazard · cgmp deviation
See all →- SevereBaxter Recalls Vasopressin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateLexia LLC Recalls Broadway Joe's Pain Cream Due to CGMP Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
Similar recalls
- SevereSanofi Recalls Over-Concentrated Docetaxel Injection Vials Nationwide
FDA (Drugs) · 2018-05-09
- LowEnoxaparin Sodium Injection Recalled for Labeling Error on Declared Strength
FDA (Drugs) · 2018-01-17
- LowSanofi Recalls Clofarabine Injection Vials Due to Incorrect Package Insert
FDA (Drugs) · 2017-11-08
- ModerateAkorn Recalls Moxifloxacin Ophthalmic Solution for CGMP Deviations
FDA (Drugs) · 2023-01-25
- SevereSanofi Recalls Auvi-Q Epinephrine Auto-Injectors Due to Defective Delivery System
FDA (Drugs) · 2016-06-01
- SevereSanofi Recalls Subpotent Rifadin Rifampin Capsules Due to Low Fill Volume
FDA (Drugs) · 2013-08-14