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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Amneal Methylprednisolone Acetate Injection Recalled for Labeling Error

Agency Publication Date: May 19, 2023
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Summary

Amneal Pharmaceuticals of New York, LLC is recalling 69,239 vials of Methylprednisolone Acetate Injectable Suspension, USP (80 mg/mL). The recall was initiated because the outer carton (secondary packaging) contains a typographical error in the National Drug Code (NDC). While the individual vials inside have the correct labeling, the outer cartons display an incorrect identification number. No incidents or injuries have been reported to date.

Risk

The typographical error on the outer packaging could lead to medication mismanagement or administrative errors at pharmacies and healthcare facilities. No medical injuries have been reported, and the individual vials contain the correct drug information.

What You Should Do

  1. This recall affects Amneal Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, 1 mL single-dose vials with lot numbers AP220481 (Exp 09/2024) and AP220536A (Exp 10/2024).
  2. Affected units can be identified by the National Drug Code (NDC) on the outer carton, which incorrectly displays 70121-1573-1 instead of the correct number, 70121-1574-1.
  3. Stop using the recalled product immediately.
  4. Contact Amneal Pharmaceuticals of New York, LLC or your medical distributor to arrange for the return of the affected stock.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information.

Your Remedy Options

๐Ÿ“‹Other Action

Professional/Clinical return for sterile injectable.

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Methylprednisolone Acetate Injectable Suspension, USP (80 mg/mL)
Variants: 80 mg/mL, 1 mL Single Dose Vial
Lot Numbers:
AP220481 (Exp 09/2024)
AP220536A (Exp 10/2024)
NDC:
70121-1574-01

Recall due to typographical error on secondary packaging: Carton incorrectly lists NDC 70121-1573-1.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92249
Status: Resolved
Manufacturer: Amneal Pharmaceuticals of New York, LLC
Sold By: pharmacies; healthcare providers
Manufactured In: India, United States
Units Affected: 69,239 vials
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.