Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807

Superpotent Drug: Due to overfilling of drug powder

Recall #: D-0442-2024
Affected scope: 821 bottles
Initiated: March 21, 2024

Compiled from official public sources by the publisher. · Updated September 2026

Amneal Pharmaceuticals of New York, LLC recalled Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL b… - a critical-severity action.

Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL b… was recalled by Amneal Pharmaceuticals of New York, LLC in April 24, 2024. Reason: Superpotent Drug: Due to overfilling of drug powder. Check the official notice for the remedy. Verify recall #D-0442-2024 with the FDA Drug before acting.

The recall

Amneal Pharmaceuticals of New York, LLC issued this critical-severity FDA Drug recall-Superpotent Drug: Due to overfilling of drug powder.

Critical
severity level: Class I
classification: April 24, 2024
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0442-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807

Reason for recall

Superpotent Drug: Due to overfilling of drug powder

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Critical (Class I)
Status	Terminated
Recall number	D-0442-2024
Date reported	April 24, 2024
Date initiated	March 21, 2024
Recalling firm	Amneal Pharmaceuticals of New York, LLC
Firm location	Brookhaven, NY
Affected scope	821 bottles
Distribution	Nationwide in the USA.

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (D-0442-2024) and product description against the item you own. Search the archive
Confirm the current status with FDA Drug before acting, recall details can be updated.
This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Superpotent Drug: Due to overfilling of drug powder

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on April 24, 2024. Severity: Critical. Recall number: D-0442-2024.

Where was the recalled product distributed? ▼

Distribution: Nationwide in the USA..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Critical), closest by report date among other firms and states.

ConSup North America Inc. Recalls Ready-T… 2024-04-24 BMW 2014-2015: AIR BAGS:SIDE/WINDOW 2024-04-24 Atovaquone Oral Suspension USP, 750 mg pe… 2024-04-24 H&NATURAL TEJOCOTE ROOT Dietary Suppleme… 2024-04-24

Similar Drugs & Medications · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

Digoxin Tablets, USP 62.5 mcg (0.0625 mg)… 2024-04-24 Sterile Diluent, HUMALOG U-100 (insulin l… 2024-04-24 S.P.Labs, Thyroid, Full Strength, Rx only… 2024-04-24 S.P Labs, Thyroid, USP, Rx only, For Manu… 2024-04-24

Compare this recall with Kian Pee Wan Capsules, 30-count bottles → · All Drugs & Medications recalls

This recall: FDA Drug, reported April 24, 2024. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026