Sandoz L-Cysteine Hydrochloride Injection Recall: Sterility Risk
Sandoz recalls pharmacy bulk vials of L-Cysteine Hydrochloride Injection due to potential sterility issues from FDA inspection concerns. Affected lots expire by July 2017.
Lower-risk recall
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Contact the company
What happened, in plain English
Sandoz is recalling pharmacy bulk vials of L-Cysteine Hydrochloride Injection because an FDA inspection raised concerns about possible sterility problems. This could lead to infections if the product is used without proper sterility. Read more at govinfonow.com/recall/42255-sandoz-l-cysteine-hydrochloride-injection-recall-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42255-sandoz-l-cysteine-hydrochloride-injection-recall-sterility-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0141-2017
Cite this page
“Sandoz L-Cysteine Hydrochloride Injection Recall: Sterility Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42255-sandoz-l-cysteine-hydrochloride-injection-recall-sterility-risk. Based on FDA recall #D-0141-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0141-2017%22&limit=1).
Why it’s dangerous
The FDA inspection found potential issues with the product's sterility. If the vials are not sterile, using them for injections could cause infections in patients.
Who’s affected
Pharmacists and healthcare facilities using the recalled vials for medical treatments. Patients receiving injections from these vials are at risk of infection.
How to tell if you have this one
Check for vials labeled L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package (NDC 66758-005-01). Look for lot numbers 2070915 through 2120215 with expiration dates up to July 2017.
- Brand
Sandoz- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide throughout the USA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0140-2017 | L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials per carton (NDC 66758-004-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.; Lot #: 2081915, 2082015, 2082115, 2082815, 2083115, Exp 08/17; 2090115, Exp 09/17 | 18,751 vials |
| D-0141-2017 | L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per carton(NDC 66758-005-02), Rx only, Manufactured for: Sandoz, Inc., Princeton, NJ.; Lot #: 2070915, 2071015, 2071415, 2071515, 2071615, 2071715, 2072115, 2072215, Exp 07/17; 2092315, 2093015, Exp 09/17; 2100115, Exp 10/17; 2120115, 2120215, Exp 12/17 | 33,624 vials |
What to do — step by step
Check Vial Lot Number
Identify the lot number on the vial to see if it matches the recalled lots (2070915 to 2120215).
Discard Recalled Vials
If the vial is in the recalled lot range, discard it immediately to avoid infection risks.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide throughout the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What lot numbers are affected?
Lots 2070915, 2071015, 2071415, 2071515, 2071615, 2071715, 2072115, 2072215 (expiring 07/17), 2092315, 2093015 (expiring 09/17), and 2100115, 2120115, 2120215 (expiring 12/17).
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0141-2017 (November 9, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0141-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.