CLASS III Drug recall · Reported 31 May 2023 · FDA Enforcement Report
Methylprednisolone Acetate Injectable Suspension recalled
Amneal Pharmaceuticals of New York is recalling Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, distributed nationwide in the US. The recall was initiated on 8 May 2023 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-0756-2023
- FDA event ID
- 92249
- Recalling firm
- Amneal Pharmaceuticals of New York, Brookhaven, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 8 May 2023
- FDA classified
- 19 May 2023
- Reported
- 31 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 8 May 2023 | Recall initiated by company | |
| 19 May 2023 | Classified by FDA | +11 days |
| 31 May 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for Intravenous Use, 1 mL Single Dose Vial, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit, Ahmedabad 382213, India, Amneal Pharamceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1574-01.
Where it was distributed
Nationwide in the USA and PR
Questions about this recall
Why was it recalled?
Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.
Which lots are affected?
Lot Numbers: AP220481, Exp 09/2024; AP220536A, Exp 10/2024
Where was it sold?
Nationwide in the USA and PR
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.
More recalls from Amneal Pharmaceuticals of New York
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Methylergonovine Maleate Tablets, USP, 0.2mg recalledMethylergonovine Maleate | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS I | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg recalledVancomycin Hydrochloride | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Divalproex Sodium Extended-release Tablets, USP 250 mg recalledDivalproex Sodium | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Oseltamivir Phosphate for Oral Suspension 6mg/ml (reconstituted) recalledOseltamivir Phosphate | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Phenoxybenzamine Hydrochloride Capsules, USP 10mg recalled | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
Other Methylprednisolone recalls
All 69| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | methylprednisolone tablets, USP Dosepak, 4 mg recalled by GreenstoneMethylprednisolone | Greenstone | Other | Nationwide |
| Drug | CLASS II | MethylPREDNISolone Acetate Injectable Suspension recalledMethylprednisolone Acetate | Sagent Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Methylprednisolone acetate Injectable Suspension recalled by Eugia USMethylprednisolone Acetate | Eugia US | Potency & Assay | 4 states |
| Drug | CLASS II | Methylprednisolone 12MG IN NS Syringe, steroid recalled | Sentara Infusion Services | Sterility | Nationwide |
| Drug | CLASS II | MethyLPREDNISolone Acetate Injectable Suspension recalled | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |