CLASS II Drug recall · Reported 13 Apr 2022 · FDA Enforcement Report
Sucralfate Oral Suspension recalled by DASH Pharmaceuticals
Dash Pharmaceuticals is recalling Sucralfate Oral Suspension, USP, distributed nationwide in the US. The recall was initiated on 11 Mar 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-0749-2022
- FDA event ID
- 89814
- Recalling firm
- Dash Pharmaceuticals, Upper Saddle River, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Mar 2022
- FDA classified
- 6 Apr 2022
- Reported
- 13 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 11 Mar 2022 | Recall initiated by company | |
| 6 Apr 2022 | Classified by FDA | +26 days |
| 13 Apr 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mix-Up
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Sucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit Dose Cups (NDC 69339-148-17) and b) 100 case of 10 mL Unit Dose Cups (NDC 69339-148-19) Rx Only, Dash Pharmaceuticals, Upper Saddle River, NJ 07458.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Labeling: Label Mix-Up
Which lots are affected?
Lot #: a) 376908P40, Exp. Date 02/28/2023; b) 376908P100, Exp. Date 02/28/2023
Where was it sold?
Nationwide within the United States
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Sucralfate recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sucralfate Tablets recalled by Amerisource Health Services | Amerisource Health Services | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sucralfate Tablets recalled by Amerisource Health Services | Amerisource Health Services | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sucralfate Tablets recalled by Nostrum Laboratories | Nostrum Laboratories | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Sucralfate Oral Suspension per PET bottle) recalled by VistaPharmSucralfate | VistaPharm | Other Bacterial Contamination | Nationwide |
| Drug | CLASS II | Sucralfate Oral Suspension per, For Oral Administration Only bottle) recalledSucralfate | VistaPharm | Potency & Assay | Nationwide |