Use caution Drug recall · FDA · Published January 14, 2020

Hikma Recalls Methylprednisolone Due to Labeling Error

Hikma Pharmaceuticals recalls 4840 vials of methylPREDNISolone Sodium Succinate due to incorrect reconstitution instructions on the label.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0801-2020Drug Hikma Pharmaceuticals ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmHikma Pharmaceuticals USA Inc.2 Esterbrook Ln · Cherry Hill, NJ 08003-4002

✎ GovInfoNow plain-language explainer

Hikma Pharmaceuticals USA Inc. is recalling one lot of methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg/vial because the vial label contains incorrect instructions. The label incorrectly instructs healthcare professionals to reconstitute the product with 16 mL of Bacteriostatic Water for Injection with Benzyl Alcohol instead of the correct volume of 8 mL. This is a Class III recall affecting 4,840 vials distributed nationwide in the USA. Read more at govinfonow.com/recall/37474-hikma-recalls-methylprednisolone-due-to-labeling-error.

Source Summary by GovInfoNow · govinfonow.com/recall/37474-hikma-recalls-methylprednisolone-due-to-labeling-error · Updated October 11, 2026 · FDA enforcement record: FDA #D-0801-2020

Cite this page

“Hikma Recalls Methylprednisolone Due to Labeling Error.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/37474-hikma-recalls-methylprednisolone-due-to-labeling-error. Based on FDA recall #D-0801-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0801-2020%22&limit=1).

The FDA announced on Jan. 14, 2020, that Hikma Pharmaceuticals USA Inc. is recalling methylPREDNISolone Sodium Succinate For Injection due to incorrect reconstitution instructions on the vial label. The hazard involves an error instructing healthcare professionals to use 16 mL instead of the correct 8 mL of diluent.

How to tell if you have it

Brand: Hikma Pharmaceuticals
Product: Methylprednisolone Sodium Succinate Injection, USP, 500 mg*/vial
NDC: 0143-9850-01
Lot #: 1901113.1
Expiration: JUL 2021
Manufacturer: HIKMA FARMACEUTICA (PORTUGAL), SA
Distributor: WEST-WARD, Eatontown, NJ 07724

The hazard

The vial label incorrectly instructs healthcare professionals to reconstitute the product with 16 mL of Bacteriostatic Water for Injection with Benzyl Alcohol instead of the correct volume of 8 mL. The FDA said this labeling error constitutes a Class III recall.

Context

GovInfoNow's records show Hikma Pharmaceuticals USA Inc. has had 14 other recalls on record since Dec. 17, 2019. Other recent recalls of similar products include American Regent Levocarnitine Injection Recall (April 16, 2026), American Health Packaging Buprenorphine Tablets Recall (Aug. 19, 2026), and ICU Medical Recalls Potassium Chloride Injection (Oct. 29, 2025).

How to tell if you have this one

Check for methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only. Look for NDC 0143-9850-01 and Lot # 1901113.1 with an expiration date of JUL 2021. The product is manufactured by HIKMA FARMACEUTICA (PORTUGAL) and distributed by WEST-WARD in Eatontown, NJ.

Brand
Hikma Pharmaceuticals
Category
Drug

Based on the official FDA remedy

What to do — step by step

Verify Lot Number
Check if your inventory includes NDC 0143-9850-01, Lot # 1901113.1, Exp JUL 2021.
Follow Correct Instructions
Reconstitute the product with 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol, not 16 mL as stated on the label.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in 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 20 months after the firm started it.

Jan 14, 2020Firm started the recall
Jan 23, 2020FDA classified it Class III
Jan 29, 2020Published in FDA’s Enforcement Report
Sep 8, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/37474-hikma-recalls-methylprednisolone-due-to-labeling-error">Hikma Recalls Methylprednisolone Due to Labeling Error (GovInfoNow)</a>

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 qwen3.6:35b-a3b on October 11, 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.