CLASS III Drug recall · Reported 29 Jan 2020 · FDA Enforcement Report
methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial recalled
Hikma Pharmaceuticals USA is recalling methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, distributed nationwide in the US. The recall was initiated on 14 Jan 2020 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0801-2020
- FDA event ID
- 84676
- Recalling firm
- Hikma Pharmaceuticals USA, Cherry Hill, NJ
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 14 Jan 2020
- FDA classified
- 23 Jan 2020
- Reported
- 29 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 14 Jan 2020 | Recall initiated by company | |
| 23 Jan 2020 | Classified by FDA | +9 days |
| 29 Jan 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for 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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #: 1901113.1, Exp JUL 2021
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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