Medications & Supplements/Prescription Drugs

Amneal Vancomycin Hydrochloride Oral Solution Recalled for Superpotency

Agency Publication Date: April 12, 2024

Summary

Amneal Pharmaceuticals has recalled approximately 821 bottles of Vancomycin Hydrochloride for Oral Solution, USP (250 mg per 5 mL) because the bottles were overfilled with drug powder. This overfilling makes the antibiotic superpotent, meaning it contains a higher dose than intended. The recall affects 80 mL, 150 mL, and 300 mL bottles from specific lots with expiration dates in September 2025.

Risk

Taking medication that is stronger than prescribed can lead to drug toxicity and serious adverse health effects. This antibiotic is used to treat specific bacterial infections of the intestines, and superpotency poses a risk of harm to patients.

What You Should Do

This recall affects Vancomycin Hydrochloride for Oral Solution, USP (250 mg per 5 mL) sold in 80 mL, 150 mL, and 300 mL bottles distributed by Amneal Pharmaceuticals LLC.
Identify your product by checking the NDC number and lot code on the bottle label. Affected items include NDC 69238-2261-3 (Lot 22613003A), NDC 69238-2261-7 (Lots 22613004A, 22613005A), and NDC 69238-2261-5 (Lot 22613005B), all with an expiration date of 09/30/2025.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Amneal Pharmaceuticals of New York, LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Vancomycin Hydrochloride for Oral Solution, USP (80 mL)

Variants: 250 mg per 5 mL, 80 mL bottle

UPC Codes:

369238226133

Lot Numbers:

22613003A (Exp 09/30/2025)

NDC:

69238-2261-3

Rx only; Distributed by Amneal Pharmaceuticals LLC

Product: Vancomycin Hydrochloride for Oral Solution, USP (150 mL)

Variants: 250 mg per 5 mL, 150 mL bottle

UPC Codes:

369238226171

Lot Numbers:

22613004A (Exp 09/30/2025)

22613005A (Exp 09/30/2025)

NDC:

69238-2261-7

Rx only; Distributed by Amneal Pharmaceuticals LLC

Product: Vancomycin Hydrochloride for Oral Solution, USP (300 mL)

Variants: 250 mg per 5 mL, 300 mL bottle

UPC Codes:

369238226157

Lot Numbers:

22613005B (Exp 09/30/2025)

NDC:

69238-2261-5

Rx only; Distributed by Amneal Pharmaceuticals LLC

Product Images

Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL, NDC 69238-2261-3

Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL, NDC 69238-2261-7

Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL, NDC 69238-2261-5

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94262

Status: Resolved

Manufacturer: Amneal Pharmaceuticals of New York, LLC

Sold By: Retail Pharmacies; Healthcare Providers

Manufactured In: United States

Units Affected: 821 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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 · FDA Press Release · 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.

Summary

What You Should Do

This recall affects Vancomycin Hydrochloride for Oral Solution, USP (250 mg per 5 mL) sold in 80 mL, 150 mL, and 300 mL bottles distributed by Amneal Pharmaceuticals LLC.

Identify your product by checking the NDC number and lot code on the bottle label. Affected items include NDC 69238-2261-3 (Lot 22613003A), NDC 69238-2261-7 (Lots 22613004A, 22613005A), and NDC 69238-2261-5 (Lot 22613005B), all with an expiration date of 09/30/2025.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Amneal Pharmaceuticals of New York, LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Vancomycin Hydrochloride for Oral Solution, USP (80 mL)

Variants: 250 mg per 5 mL, 80 mL bottle

UPC Codes:

369238226133

Lot Numbers:

22613003A (Exp 09/30/2025)

NDC:

69238-2261-3

Rx only; Distributed by Amneal Pharmaceuticals LLC

Product: Vancomycin Hydrochloride for Oral Solution, USP (150 mL)

Variants: 250 mg per 5 mL, 150 mL bottle

UPC Codes:

369238226171

Lot Numbers:

22613004A (Exp 09/30/2025)

22613005A (Exp 09/30/2025)

NDC:

69238-2261-7

Rx only; Distributed by Amneal Pharmaceuticals LLC

Product: Vancomycin Hydrochloride for Oral Solution, USP (300 mL)

Variants: 250 mg per 5 mL, 300 mL bottle

UPC Codes:

369238226157

Lot Numbers:

22613005B (Exp 09/30/2025)

NDC:

69238-2261-5

Rx only; Distributed by Amneal Pharmaceuticals LLC