---
title: "Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container... — FDA record D-0555-2022 | Is It on Recall"
description: "CGMP Deviations"
url: https://isitonrecall.com/recall/fda-drug-d-0555-2022-cystex-tablet-sodium-salicylate-162-5-mg-methenamine-162-mg-bulk-container-ultratab-laboratories-inc/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## 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

[Open the official record](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0555-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). 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.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0555-2022%22)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [ULTRAtab Laboratories, Inc. records](https://isitonrecall.com/brand/ultratab-laboratories-inc/)