CLASS II Drug recall · Reported 14 Apr 2021 · FDA Enforcement Report
Neomycin Sulfate Tablets, USP 500mg recalled by X-Gen Pharmaceuticals
X-Gen Pharmaceuticals is recalling Neomycin Sulfate Tablets, USP 500mg, distributed nationwide in the US. The recall was initiated on 19 Mar 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0328-2021
- FDA event ID
- 87500
- Recalling firm
- X-Gen Pharmaceuticals, Horseheads, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Mar 2021
- FDA classified
- 8 Apr 2021
- Reported
- 14 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 19 Mar 2021 | Recall initiated by company | |
| 8 Apr 2021 | Classified by FDA | +20 days |
| 14 Apr 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14814. NDC 39822-0310-5
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
Which lots are affected?
Lot # CFMBX, EXP 9/2022
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from X-Gen Pharmaceuticals
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cyclophosphamide for Injection, USP, 500mg/vial recalled | X-Gen Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Cyclophosphamide for Injection, USP, Lyophilized recalled | X-Gen Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Levetiracetam Injection, 500 mg/-use vials recalled | X-Gen Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Clonidine HCL Injection, 1000 mcg/ (100 mcg/mL) Single Dose Vial recalledClonidine | X-Gen Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Nystatin Topical Powder, USP, 100,000 USP units per gram recalled | X-Gen Pharmaceuticals | Particulate Matter | Nationwide |
Other Neomycin recalls
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Neomycin and Polymyxin B Sulfates recalled by Akorn | Akorn | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Neomycin Sulfate Tablets, USP 500 mg recalledNeomycin Sulfate | Teva Pharmaceuticals USA | Foreign Material | Nationwide |
| Drug | CLASS II | Neomycin and Polymyxin B Sulfates recalled by Mckesson Medical-SurgicalNeomycin And Polymyxin B Sulfates And Dexamethasone | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Neomycin Sulf Tablets, USP, 500mg recalled by Cardinal HealthNeomycin Sulfate | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS III | Neomycin and Polymyxin B Sulfates recalled by SandozNeomycin And Polymyxin B Sulfates And Dexamethasone | Sandoz | Packaging Defects | Nationwide |