Cystex Tablet — Class II drug recall D-0555-2022
Terminated recall by ULTRAtab Laboratories, Inc., reported 2022-02-16. CGMP Deviations
| Recall number | D-0555-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ULTRAtab Laboratories, Inc., Highland, NY, United States |
| Recall initiated | 2022-01-26 |
| Classified | 2022-02-09 |
| Reported by FDA | 2022-02-16 |
| Terminated | 2025-01-07 |
| Quantity | 37,464,418 tablets |
| Reason classes | cgmp |
| NDC | 62959-0945-00 |
| Lot numbers | 18J072, 18K030, 18L123, 19A043, 19A093, 19B062, 19C079, 19C080, 19D041, 19E035, 19E087, 19G084, 19H098 |
Product
Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY 62959-945-00
Reason for recall
CGMP Deviations
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-0555-2022. 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.