Hikma Pharmaceuticals USA Inc. recalls Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-ward Eatontown, NJ
Hikma Pharmaceuticals recalls 0.9% Sodium Chloride Injection vials with failed pH tests. These vials may not be safe for medical use. Check your vial's lot number and expiration date to see if it's affected.
Recall notice
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
Contact the company & request your remedy
What happened, in plain English
Hikma Pharmaceuticals is recalling certain 0.9% Sodium Chloride Injection vials due to failed pH test results. This could mean the solution is not safe for medical use, potentially causing harm if used improperly. Read more at govinfonow.com/recall/36628-hikma-sodium-chloride-injection-recall-failed-ph-test-results.
Source Summary by GovInfoNow · govinfonow.com/recall/36628-hikma-sodium-chloride-injection-recall-failed-ph-test-results · Updated October 4, 2026 · FDA enforcement record: FDA #D-0169-2021
Cite this page
“Hikma Sodium Chloride Injection Recall: Failed pH Test Results.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36628-hikma-sodium-chloride-injection-recall-failed-ph-test-results. Based on FDA recall #D-0169-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0169-2021%22&limit=1).
Why it’s dangerous
The vials failed pH testing, which means the solution may not be at the correct acidity level. This could lead to improper medical outcomes if used in treatments. However, the exact risk level is not specified in the recall.
Who’s affected
Healthcare professionals and patients who have been prescribed this medication. Those using the recalled vials for medical treatments are at risk.
How to tell if you have this one
Check for vials with the lot numbers: 048315 (exp 4/2021), 068320 (exp 6/2021), 128302 (exp 12/2021), or 099349 (exp 9/2022). These vials were manufactured by Hikma in Eatontown, NJ.
- Brand
Hikma Pharmaceuticals- Category
Drug
What to do — step by step
Check Vial Details
Look for the lot numbers listed: 048315, 068320, 128302, or 099349 on the vial.
Questions people ask
Why is this product being recalled?
The vials failed pH testing, which means the solution may not be at the correct acidity level for medical use.
How can I tell if I have a recalled vial?
Check the lot number on the vial: 048315 (exp 4/2021), 068320 (exp 6/2021), 128302 (exp 12/2021), or 099349 (exp 9/2022).
What should I do if I have a recalled vial?
The recall record does not specify a remedy, so contact Hikma Pharmaceuticals for further instructions.
Contact Hikma Pharmaceuticals
We’ve drafted a message you can send Hikma Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0169-2021 — Hikma Pharmaceuticals Hikma Pharmaceuticals Hello, I own a Hikma Pharmaceuticals that is covered by recall D-0169-2021 from Hikma Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0169-2021 (December 7, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0169-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.