Pyridostigmine Bromide Oral Solution — Class II drug recall D-0018-2023
Terminated recall by VistaPharm, Inc., reported 2022-11-02, distributed nationwide. cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
| Recall number | D-0018-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | VistaPharm, Inc., Largo, FL, United States |
| Recall initiated | 2022-09-30 |
| Classified | 2022-10-21 |
| Reported by FDA | 2022-11-02 |
| Terminated | 2024-04-30 |
| Distributed | Nationwide (US) |
| Quantity | 1,980 cups |
| Reason classes | potency, cgmp, specification failure |
| NDC | 66689-0406, 66689-0406-01, 66689-0406-10 |
| Lot numbers | 832400 |
| Expiration dates | 2023-08 |
Product
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
Reason for recall
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0018-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.