CLASS II Drug recall · Reported 2 Nov 2022 · FDA Enforcement Report
Pyridostigmine Bromide Oral Solution, USP 60 mg/ Delivers recalled
VistaPharm is recalling Pyridostigmine Bromide Oral Solution, USP 60 mg/ Delivers, distributed nationwide in the US. The recall was initiated on 30 Sep 2022 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-0018-2023
- FDA event ID
- 90943
- Recalling firm
- VistaPharm, Largo, FL
- Manufacturer
- VistaPharm, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Sep 2022
- FDA classified
- 21 Oct 2022
- Reported
- 2 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 30 Sep 2022 | Recall initiated by company | |
| 21 Oct 2022 | Classified by FDA | +21 days |
| 2 Nov 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
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
Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689-406-01
Where it was distributed
USA Nationwide
Questions about this recall
Is Pyridostigmine Bromide Oral Solution, USP 60 mg/ Delivers recalled?
Yes. VistaPharm recalled Pyridostigmine Bromide Oral Solution, USP 60 mg/ Delivers on 30 Sep 2022. The recall is Class II and its status is Terminated. Recall number D-0018-2023.
Why was it recalled?
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Which lots are affected?
Lot#: 832400, Exp 08/2023
Where was it sold?
USA Nationwide
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 21 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 VistaPharm
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|---|---|---|---|---|---|
| Drug | CLASS III | Aminocaproic Acid Oral Solution/mL recalled by VistaPharm | VistaPharm | Packaging Defects | Nationwide |
| Drug | CLASS III | Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL recalledMycophenolate Mofetil | VistaPharm | Other | Nationwide |
| Drug | CLASS I | Sucralfate Oral Suspension per PET bottle) recalled by VistaPharmSucralfate | VistaPharm | Sterility | Nationwide |
| Drug | CLASS II | Sucralfate Oral Suspension per, For Oral Administration Only bottle) recalledSucralfate | VistaPharm | Potency & Assay | Nationwide |
| Drug | CLASS II | Clobazam Oral Suspension 5 mg/mL recalled by VistaPharm | VistaPharm | Potency & Assay | Nationwide |
Other Pyridostigmine Bromide recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pyridostigmine Bromide Tablets USP, 60 mg recalled by Corepharma | Corepharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Pyridostigmine Bromide Tablets 60 mg recalled by Core Pharma | Core Pharma | Potency & Assay | Nationwide |