Hikma Pharmaceuticals USA Inc. recalls methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL),
Hikma Pharmaceuticals recalls 500mg injection vials due to incorrect label instructions for reconstitution with 16mL instead of 8mL. This could lead to improper dosing.
Lower-risk recall
Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.
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What happened, in plain English
Hikma Pharmaceuticals is recalling 500mg methylPREDNISolone Sodium Succinate injection vials because the label incorrectly instructs healthcare professionals to use 16mL of water instead of the correct 8mL. This could result in improper dosing of the medication. Read more at govinfonow.com/recall/37474-hikma-methylprednisolone-sodium-succinate-injection-recall-incorrect-reconstitution-instructions.
Source Summary by GovInfoNow · govinfonow.com/recall/37474-hikma-methylprednisolone-sodium-succinate-injection-recall-incorrect-reconstitution-instructions · Updated October 5, 2026 · FDA enforcement record: FDA #D-0801-2020
Cite this page
“Hikma methylPREDNISolone Sodium Succinate injection recall: Incorrect reconstitution instructions.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37474-hikma-methylprednisolone-sodium-succinate-injection-recall-incorrect-reconstitution-instructions. Based on FDA recall #D-0801-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0801-2020%22&limit=1).
Why it’s dangerous
The vial label incorrectly states to reconstitute with 16mL of Bacteriostatic Water for Injection with Benzyl Alcohol instead of the correct 8mL. This could lead to improper dosing of the medication if healthcare professionals follow the incorrect instructions.
Who’s affected
Healthcare professionals who use the recalled vials for injections. Patients receiving this medication under a doctor's prescription are not directly affected by the labeling error.
How to tell if you have this one
The product is a 500mg injection vial labeled 'methylPREDNISolone Sodium Succinate For Injection, USP, Rx Only'. It was manufactured by Hikma Farmaceutica (Portugal) and distributed by West-Ward in Eatontown, NJ. The lot number is 1901113.1 and expires July 2021.
- Brand
Hikma Pharmaceuticals- Category
Drug
What to do — step by step
Check Vial Label
Verify the reconstitution instructions on the vial label to ensure it specifies 8mL of Bacteriostatic Water for Injection with Benzyl Alcohol.
Questions people ask
Is this product safe to use?
The product is safe to use if healthcare professionals follow the correct reconstitution instructions of 8mL, but the label currently has an error.
How can I tell if I have the recalled product?
Check for the lot number 1901113.1 on the vial, which expires July 2021, and ensure it was manufactured by Hikma Farmaceutica (Portugal).
Do I need to stop using this product?
No, healthcare professionals should check the label instructions before use; the product itself is not unsafe but the labeling error requires verification.
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-0801-2020 — Hikma Pharmaceuticals Hikma Pharmaceuticals Hello, I own a Hikma Pharmaceuticals that is covered by recall D-0801-2020 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-0801-2020 (January 14, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0801-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.