Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0448-2022·Announced 2022-02-02

Vancomycin HCl Oral Solution Recalled for CGMP Deviations

Edge Pharma is voluntarily recalling 6,925 syringes of Vancomycin HCl Oral Solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations discovered during the manufacturing process.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as Class II, and the source text documents CGMP deviations without reporting any illnesses, injuries, or confirmed product harm. This meets the criteria for a Moderate severity score: a voluntary precautionary recall based on manufacturing process deviations rather than confirmed safety incidents.

Plain-English summary

Edge Pharma, LLC is voluntarily recalling Vancomycin HCl Oral Solution (PF) 125 mg / 2.5 mL (50 mg/mL), 2.5 mL per syringe, Single Dose Syringe for Oral Use Only, manufactured in Colchester, Vermont, with NDC 05446-1348-01. A total of 6,925 syringes have been distributed nationwide.

The recall was initiated because Edge Pharma identified Current Good Manufacturing Practice (CGMP) deviations during manufacturing of the affected batches. The affected lot codes are: 09-2021-10@3 (dated 12-09-2021), 09-2021-17@6 (dated 12-16-2021), 09-2021-24@8 (dated 12-23-2021), 09-2021-30@7 (dated 12-29-2021), and 10-2021-13@6 (dated 01-11-2022).

This is a voluntary, firm-initiated Class II recall. Patients taking this medication should consult their healthcare provider or pharmacist about next steps. Healthcare providers should remove the affected lots from inventory and return them through their normal distribution channels.

The recalled product

Product: Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single Dose Syringe for Oral Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01
Manufacturer: Edge Pharma, LLC
Category: Drug — Oral Solution
Hazard: cgmp-deviation
manufacturing-defect
Affected units: 6,925

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 (4)

09-2021-10@3 12-09-2021
09-2021-17@6 12-16-2021
09-2021-24@8 12-23-2021
09-2021-30@7 12-29-2021 & 10-2021-13@6 01-11-2022 .

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 56 recalled by Edge Pharma, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 56 products in this recall →

Same manufacturer · Edge Pharma, LLC

See all →

Moderate
Profound-PE Dental Gel Recalled for Manufacturing Deviations
FDA (Drugs) · 2022-02-02
Severe
MVASI Sterile Ophthalmic Solution Lacks Assured Sterility
FDA (Drugs) · 2022-02-02
Moderate
LET Topical Gel drug recall for CGMP deviations
FDA (Drugs) · 2022-02-02
Severe
Vancomycin HCl Injection Recalled for Sterility Assurance Issues
FDA (Drugs) · 2022-02-02
Moderate
CSF-HC Otic Powder Drug Recalled for Manufacturing Deviations
FDA (Drugs) · 2022-02-02

Same hazard · cgmp deviation