Drug recall: methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL)…

Class III FDA enforcement event 84676. Recall start date: 14 Jan 2020. Status in the FDA record: Terminated. Termination date: 8 Sep 2021.

Reason for recall, in the words of FDA

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.

Class III, in the words of FDA

a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

Hikma Pharmaceuticals USA Inc. started this drug recall on 14 Jan 2020. The firm address in the FDA record is in Cherry Hill, NJ. FDA put the recall in Class III. FDA event 84676 has 1 product record. The first FDA enforcement report date is 29 Jan 2020. The record gives the status Terminated, with the termination date 8 Sep 2021.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide in the USA

Recalling firm

Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 84676: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0801-2020	methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01.	4840 vials	Class III	Terminated	29 Jan 2020

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class III: The lowest of the three FDA recall classes.

The event in context

Drug events that started in 2020: 342
Share of these events in Class III: 21%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 15

Other events of the firm

Other FDA enforcement events of Hikma Pharmaceuticals USA Inc.
Initiated	Product (first record)	Type	Class	Records
24 Aug 2026	Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bott	Drug	Class II	1
7 Apr 2026	Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceu	Drug	Class II	1
22 Jul 2025	Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, ND	Drug	Class II	1
8 Jul 2024	Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Man	Drug	Class I	1
12 Mar 2024	Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley He	Drug	Class II	1
11 May 2023	Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25	Drug	Class II	1
16 Dec 2022	Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE Gm	Drug	Class II	1
11 Jul 2022	Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724	Drug	Class II	4
5 Aug 2021	Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie G	Drug	Class III	1
7 Dec 2020	Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-ward Eatontown, NJ 0	Drug	Class II	1

Hikma Pharmaceuticals USA Inc.: all 15 events

Official channels

FDA enforcement report D-0801-2020The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 84676. https://recallregister.com/fda/iii/84676/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide in the USA
What quantity of product is in FDA event 84676?: The FDA record gives this quantity: 4840 vials
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2020 have the same class?: 21% of the 342 drug events that started in 2020 are in Class III.