Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported April 24, 2024
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
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
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 FDA Drug action (record #D-0442-2024) was formally reported on April 24, 2024, with the manufacturer initiating the action on March 21, 2024. It is classified under Critical severity (Class I), with a current status of Terminated. Amneal Pharmaceuticals of New York, LLC is listed as the recalling firm, operating out of Brookhaven, NY. Federal records list the affected scope as 821 bottles.
The documented reason for this recall is: Superpotent Drug: Due to overfilling of drug powder Distribution data in the federal record shows the product reached: Nationwide in the USA.. Distribution scope 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, 5 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.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
821 bottles
Related Recalls
6
5 from same agency
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
| 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? ▼
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. Recalled by Amneal Pharmaceuticals of New York, LLC. Units affected: 821 bottles.
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0442-2024) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Safecor Health, LLC · 2026-05-27
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fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3…
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FDA Drug Moderate
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported April 24, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.