---
title: "Amneal: Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL — FDA announcement Mar 27, 2024 | Is It on Recall"
description: "Super potent due to bottles being overfilled"
url: https://isitonrecall.com/recall/fdapress-2ac17743686da5b4-amneal-vancomycin-hydrochloride-for-oral-solution-usp-250-mg-5ml/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA company announcement

# Amneal: Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL — FDA announcement Mar 27, 2024

Reported terminated

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Mar 27, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL
- **Reason**: Super potent due to bottles being overfilled
- **Classification**: Not supplied
- **Recalling firm**: Amneal Pharmaceuticals, LLC.
- **Quantity**: Not supplied
- **Agency-reported status**: Terminated in FDA listing
- **Source record identifier**: 2ac17743686da5b4

[Open the official record](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-nationwide-voluntary-recall-vancomycin-hydrochloride-oral-solution)

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | The Vancomycin HCl for Oral Solution, USP, 250 mg/5mL subject to the recall, are identified by the NDC numbers stated on the product label. The following lot numbers of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL are included in this recall.; Consumers who have Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/mL should examine the bottle, cease using the product if the lot number is listed on the recall and contact Amneal via telephone or email for recall information and for product return instructions. Consumers may call Amneal at 1-833-582-0812 Monday – Friday, 8:00 am – 5:00 pm, EST, or email Vancomycin\_Recall@amneal.com for further information and instructions for the product return. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.; NDC No. \| Lot \| Expiration Date \| Pack Size; 69238-2261-3 \| 22613003A \| 09/2025 \| 80 mL; 69238-2261-7 \| 22613004A \| 09/2025 \| 150 mL; 69238-2261-7 \| 22613005A \| 09/2025 \| 150 mL; 69238-2261-5 \| 22613005B \| 09/2025 \| 300 mL |

Match all identifying details in the current notice. A brand name alone is not enough.

## Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

**FDA company announcement, table 1**

| NDC No. | Lot | Expiration Date | Pack Size |
| --- | --- | --- | --- |
| 69238-2261-3 | 22613003A | 09/2025 | 80 mL |
| 69238-2261-7 | 22613004A | 09/2025 | 150 mL |
| 69238-2261-7 | 22613005A | 09/2025 | 150 mL |
| 69238-2261-5 | 22613005B | 09/2025 | 300 mL |

Announcement retrieved Oct 1, 2026. [Official announcement](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-nationwide-voluntary-recall-vancomycin-hydrochloride-oral-solution).

## Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Fda listing date**: Mar 27, 2024
- **Company announcement date**: Mar 27, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Consumers who have Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/mL should examine the bottle, cease using the product if the lot number is listed on the recall and contact Amneal via telephone or email for recall information and for product return instructions. Consumers may call Amneal at 1-833-582-0812 Monday – Friday, 8:00 am – 5:00 pm, EST, or email Vancomycin\_Recall@amneal.com for further information and instructions for the product return. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. If you would like to report any adverse reactions or quality problems experienced with the use of this product you may contact Amneal Drug Safety by phone at 1-877-835-5472, Monday - Friday, 8:00 am – 6:00 pm, EST, or via e-mail at DrugSafety@amneal.com.

[Read the current instructions](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-nationwide-voluntary-recall-vancomycin-hydrochloride-oral-solution)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [Amneal Pharmaceuticals, LLC records](https://isitonrecall.com/brand/amneal-pharmaceuticals-llc/)