Hikma Pharmaceuticals USA Inc. recalls Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile
Hikma Pharmaceuticals recalls 0.9% Sodium Chloride Injection vials with failed pH tests. These products may not meet USP standards and could cause issues if used in medical procedures.
Lower-risk recall
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
Contact the company & request your remedy
What happened, in plain English
Hikma Pharmaceuticals is recalling 0.9% Sodium Chloride Injection vials that failed pH testing. This could mean the solution isn't safe for medical use, potentially causing complications during procedures. Read more at govinfonow.com/recall/36691-hikma-sodium-chloride-injection-recall-failed-ph-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/36691-hikma-sodium-chloride-injection-recall-failed-ph-specifications · Updated October 4, 2026 · FDA enforcement record: FDA #D-0101-2021
Cite this page
“Hikma Sodium Chloride Injection Recall: Failed pH Specifications.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36691-hikma-sodium-chloride-injection-recall-failed-ph-specifications. Based on FDA recall #D-0101-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0101-2021%22&limit=1).
Why it’s dangerous
The injection vials failed pH testing, meaning the solution may not meet USP standards. This could lead to improper medical procedures if used without correction.
Who’s affected
Patients receiving this injection for medical procedures. Healthcare providers using the product for sterile diluents are most at risk.
How to tell if you have this one
Check for vials with NDC 0641-0497-17 or cartons with NDC 0641-0497-25. Look for specific lot numbers: 078338 (exp. 7/2021), 088391 (exp. 08/2021), 098340 (exp. 09/2021), 108325 (exp. 10/2021), or 010018 (exp. 1/2023).
- Brand
Hikma Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Identify the NDC number and lot numbers listed in the recall notice to confirm if your vial is affected.
Questions people ask
Is this product safe to use?
The recall states the vials failed pH testing, so they may not meet USP standards. Do not use these vials for medical procedures.
What should I do if I have this product?
The recall does not specify a remedy, so contact Hikma Pharmaceuticals for guidance on handling affected products.
How can I tell if my vial is part of this recall?
Check for vials with NDC 0641-0497-17 or cartons with NDC 0641-0497-25 and the specific lot numbers listed in the recall notice.
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-0101-2021 — Hikma Pharmaceuticals Hikma Pharmaceuticals Hello, I own a Hikma Pharmaceuticals that is covered by recall D-0101-2021 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-0101-2021 (November 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0101-2021 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.