Vancomycin Hydrochloride for Oral Solution recall
FDA recall D-0442-2024 · initiated Mar 21, 2024
Amneal Pharmaceuticals of New York, LLC recalled Vancomycin Hydrochloride for Oral Solution in Mar 2024 — an FDA Class I recall (D-0442-2024) because Superpotent Drug: Due to overfilling of drug powder.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Superpotent Drug: Due to overfilling of drug powder
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 821 bottles
Details
- Product
- 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
- Recalling company
- Amneal Pharmaceuticals of New York, LLC
- Classification
- Class I
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA.
- Initiated
- Mar 21, 2024
- FDA report date
- Apr 24, 2024
Frequently asked
- Was Vancomycin Hydrochloride for Oral Solution recalled?
- Amneal Pharmaceuticals of New York, LLC recalled Vancomycin Hydrochloride for Oral Solution in Mar 2024 — an FDA Class I recall (D-0442-2024) because Superpotent Drug: Due to overfilling of drug powder. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Vancomycin Hydrochloride for Oral Solution recalled?
- Per the FDA enforcement record, the reason for recall D-0442-2024 was: Superpotent Drug: Due to overfilling of drug powder
- Is a recalled Vancomycin Hydrochloride for Oral Solution dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Vancomycin Hydrochloride for Oral Solution are affected?
- Distributed: Nationwide in the USA.. The recall covers these lots — Lot # (a) 22613003A, Exp. date 09/30/2025; (b) 22613004A, 22613005A, Exp. date 09/30/2025; (c) 22613005B, Exp. date 09/30/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0442-2024.