Sucralfate recalls

The FDA has published 6 recalls involving Sucralfate since 2022. The latest was reported on 22 Oct 2025. Most were for manufacturing (cgmp) deviations. Amerisource Health Services has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls6since 2022

Last 12 months0reported

Class I117% of total

Ongoing3latest 22 Oct 2025

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 0 0 0Jun 0 1 1Sep 1 0 0Dec 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0

Severity split

Class I 1 17%Class II 5 83%Class III 0 0%

Why sucralfate is recalled

Companies

By year

2025350%
2023233%
2022117%

Ongoing sucralfate recalls

3 active

Reported	Class	Recall	Company	Reason	Where
22 Oct 2025Drug	CLASS II	Sucralfate Tablets recalled by Amerisource Health Services	Amerisource Health Services	Manufacturing (CGMP) Deviations	Nationwide
3 Sep 2025Drug	CLASS II	Sucralfate Tablets recalled by Amerisource Health Services	Amerisource Health Services	Manufacturing (CGMP) Deviations	Nationwide
6 Aug 2025Drug	CLASS II	Sucralfate Tablets recalled by Nostrum Laboratories	Nostrum Laboratories	Manufacturing (CGMP) Deviations	Nationwide

All sucralfate recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
22 Oct 2025Drug	CLASS II	Sucralfate Tablets recalled by Amerisource Health Services	Amerisource Health Services	Manufacturing (CGMP) Deviations	Nationwide
3 Sep 2025Drug	CLASS II	Sucralfate Tablets recalled by Amerisource Health Services	Amerisource Health Services	Manufacturing (CGMP) Deviations	Nationwide
6 Aug 2025Drug	CLASS II	Sucralfate Tablets recalled by Nostrum Laboratories	Nostrum Laboratories	Manufacturing (CGMP) Deviations	Nationwide
25 Oct 2023Drug	CLASS I	Sucralfate Oral Suspension per PET bottle) recalled by VistaPharmSucralfate	VistaPharm	Other Bacterial Contamination	Nationwide
20 Sep 2023Drug	CLASS II	Sucralfate Oral Suspension per, For Oral Administration Only bottle) recalledSucralfate	VistaPharm	Potency & Assay	Nationwide
13 Apr 2022Drug	CLASS II	Sucralfate Oral Suspension recalled by DASH Pharmaceuticals	Dash Pharmaceuticals	Packaging Defects	Nationwide

Should you stop taking Sucralfate?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.