Sandoz Phenylephrine Injection Recall: Risk of Contaminated Product
Sandoz recalls phenylephrine injections due to potential sterility issues found during FDA inspection. Products with specific NDC numbers and expiration dates are affected. Consumers should contact Sandoz for details.
Recall notice
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Contact the company
What happened, in plain English
Sandoz is recalling phenylephrine injections that may not be sterile, as found during an FDA inspection. This could lead to infections if the product is used. Affected products have specific NDC numbers and expiration dates. Read more at govinfonow.com/recall/42470-sandoz-phenylephrine-injection-recall-risk-of-contaminated-product.
Source Summary by GovInfoNow · govinfonow.com/recall/42470-sandoz-phenylephrine-injection-recall-risk-of-contaminated-product · Updated October 9, 2026 · FDA enforcement record: FDA #D-1514-2016
Cite this page
“Sandoz Phenylephrine Injection Recall: Risk of Contaminated Product.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42470-sandoz-phenylephrine-injection-recall-risk-of-contaminated-product. Based on FDA recall #D-1514-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1514-2016%22&limit=1).
Why it’s dangerous
The FDA inspection found concerns that the product might not be sterile. If the injection is not sterile, it could cause infections when used in medical procedures.
Who’s affected
People who have the recalled phenylephrine injections (NDC 66758-016-03 or 66758-017-01) are affected. Those using the product for medical purposes are at risk of infection.
How to tell if you have this one
Check for NDC numbers 66758-016-03 (25 x 5 mL vials) or 66758-017-01 (10 mL vials) with expiration dates listed as 09/16 or 08/16.
- 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 and Puerto Rico
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1513-2016 | Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.; Lot #: 080514, 080614, 081114, 081214, 081314, 081414, 082714, 082814, 082914, Exp 08/16; 090214, 090314, 090814, 090914, 091014, 091114, 091214, 091514, Exp 09/16 | 32,099 cartons |
| D-1514-2016 | Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758-016-04) and b) 10 mL Vials, 100 mg/10 mL (NDC 66758-017-01), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.; Lot #: a) 091914, Exp 09/16; b) 080114, Exp 08/16; 090414, 092614, Exp 09/16 | a) 1,584 cartons; b) 62,170 vials |
What to do — step by step
Check Product Details
Look for the NDC numbers 66758-016-03 or 66758-017-01 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” 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.
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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-1514-2016 (August 24, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1514-2016 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 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.