Vancomycin Hydrochloride Oral Solution Recalled Nationwide for Superpotency Due to Overfilling
Amneal Pharmaceuticals is recalling Vancomycin Hydrochloride Oral Solution nationwide due to manufacturing overfilling causing superpotency with higher-than-labeled concentration. The FDA classified this as Class I.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA classified this as Class I, the highest agency classification, which requires minimum severity score of 4 per the rubric. The hazard is overfilled product containing higher-than-labeled drug concentration, creating risk from elevated dosing.
Plain-English summary
Amneal Pharmaceuticals of New York, LLC is recalling Vancomycin Hydrochloride for Oral Solution, USP 250 mg per 5 mL, distributed nationwide in the United States. The affected product is packaged in 80 mL (NDC 69238-2261-3), 150 mL (NDC 69238-2261-7), and 300 mL (NDC 69238-2261-5) bottles, with approximately 821 bottles involved in the recall.
The product was recalled due to overfilling of drug powder during manufacturing, resulting in superpotent product containing a higher concentration of active ingredient than the labeled strength. The affected lot numbers are 22613003A, 22613004A, 22613005A, and 22613005B, all with an expiration date of September 30, 2025.
The FDA classified this as a Class I recall, indicating the highest level of hazard. Patients taking this medication expect dosing based on the labeled concentration of 250 mg per 5 mL; product with higher actual concentration than labeled creates a serious public health hazard.
The recalled product
- Product
- VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
- Brand
- VANCOMYCIN HYDROCHLORIDE
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Category
- Drug
- Affected units
- 821
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot # (a) 22613003A
- Exp. date 09/30/2025
- (b) 22613004A
- 22613005A
- (c) 22613005B
UPCs (3)
- 0369238226133
- 0369238226157
- 0369238226171
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · VANCOMYCIN HYDROCHLORIDE
- SevereBaxter Recalls Vancomycin Injection Due to CGMP Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Vancomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- CriticalVancomycin Hydrochloride Injection Recalled for Glass Particulate Matter
FDA (Drugs) · 2023-02-01
- ModerateAuroMedics Recalls Vancomycin Hydrochloride Vials Due to Discoloration
FDA (Drugs) · 2019-12-18
- CriticalPfizer Recalls Vancomycin Hydrochloride Vials Due to Glass Particulate Matter
FDA (Drugs) · 2017-12-27
Same manufacturer · Amneal Pharmaceuticals of New York, LLC
See all →- HighAmneal Recalls Exenatide Injection Pens Due to Potential Empty Delivery System
FDA (Drugs) · 2026-09-30
- HighMethylergonovine Maleate tablets recalled for failed dissolution specifications
FDA (Drugs) · 2024-05-08
- HighDivalproex Sodium 250 mg tablets recalled for failed dissolution specifications
FDA (Drugs) · 2024-04-03
- ModerateFDA Recalls Oseltamivir Phosphate Oral Suspension for Out-of-Specification Impurities
FDA (Drugs) · 2024-02-28
- HighAmneal Phenoxybenzamine Hydrochloride Capsules 10mg Recalled Due to Unknown Impurity
FDA (Drugs) · 2024-02-14
Same hazard · superpotency
See all →- CriticalVitruvias Recalls Superpotent Thyroid Tablets Nationwide
FDA (Drugs) · 2026-09-23
- HighAripiprazole 10 mg tablets recalled after testing superpotent in one lot
FDA (Drugs) · 2025-09-24
- ModerateHYDROmorphone Hydrochloride 50 mg Cassettes Recalled for Superpotency
FDA (Drugs) · 2025-04-30
- HighLevothyroxine Sodium Tablets Recalled Nationwide for Potency Variance
FDA (Drugs) · 2024-12-18
- HighLevothyroxine Sodium Tablets Recalled for Subpotent and Superpotent Content
FDA (Drugs) · 2024-12-18
Similar recalls
- SevereActavis Recalls Subpotent Vancomycin Hydrochloride Capsules Nationwide
FDA (Drugs) · 2014-06-25
- SevereActavis Recalls Vancomycin Hydrochloride Capsules Due to Subpotent Drug
FDA (Drugs) · 2015-03-11
- SevereAmneal Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity
FDA (Drugs) · 2020-07-01
- ModerateFDA Recalls Vancomycin HCl Due to Missing Stability Data
FDA (Drugs) · 2018-02-28
- ModeratePharmedium Recalls Vancomycin Bags With Incorrect Volume Labeling
FDA (Drugs) · 2017-06-21
- HighAmneal Phenoxybenzamine Hydrochloride Capsules 10mg Recalled Due to Unknown Impurity
FDA (Drugs) · 2024-02-14