Recall archive / FDA drug enforcement
Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland,... — FDA record D-0555-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 26, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY 62959-945-00
- Reason
- CGMP Deviations
- Classification
- Class II
- Recalling firm
- ULTRAtab Laboratories, Inc.
- Quantity
- 37,464,418 tablets
- Agency-reported status
- Terminated
- Source record identifier
- D-0555-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Product Codes: M945 Bulk Lots: 18J072, 18K030, 18L123, 19A043, 19A093, 19B062, 19C079, 19C080, 19D041, 19E035, 19E087, 19G084, 19H098 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Bulk product was distributed to 3 distributors who may have distributed finished product.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Feb 16, 2022
- Recall initiation date
- Jan 26, 2022
- Center classification date
- Feb 9, 2022
- Termination date
- Jan 7, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.