CLASS II ONGOING Drug recall · Reported 3 Sep 2025 · FDA Enforcement Report

Sucralfate Tablets recalled by Amerisource Health Services

Amerisource Health Services is recalling Sucralfate Tablets, USP, distributed nationwide in the US. The recall was initiated on 29 Jul 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 1015038, Exp Date 07/31/2025, Lot 1015898, Exp Date 09/30/2025; Lot 1016873, Exp Date 10/31/2025 and Lot 1023398, Exp Date 07/31/2026.

Quantity recalled26,992 blister packs

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-0598-2025
FDA event ID: 97361
Recalling firm: Amerisource Health Services, Columbus, OH
Classification: Class II
Status: Ongoing
Recall initiated: 29 Jul 2025
FDA classified: 22 Aug 2025
Reported: 3 Sep 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations

Timeline

29 Jul 2025	Recall initiated by company
22 Aug 2025	Classified by FDA	+24 days
3 Sep 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

Product as listed by the FDA

Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot 1015038, Exp Date 07/31/2025, Lot 1015898, Exp Date 09/30/2025; Lot 1016873, Exp Date 10/31/2025 and Lot 1023398, Exp Date 07/31/2026.

Where was it sold?

Nationwide

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.

More recalls from Amerisource Health Services

All 69

Reported	Class	Recall	Company	Reason	Where
27 May 2026Drug	CLASS III	Primidone Tablets, USP, 250 mg ( unit dose blister) recalledPrimidone	Amerisource Health Services	Packaging Defects	Nationwide
27 May 2026Drug	CLASS III	Primidone Tablets, USP, 50 mg ( unit dose blister) recalledPrimidone	Amerisource Health Services	Packaging Defects	Nationwide
1 Apr 2026Drug	CLASS II	Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) [] recalledMeclizine Hydrochloride	Amerisource Health Services	Packaging Defects	Nationwide
18 Feb 2026Drug	CLASS II	Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride	Amerisource Health Services	Packaging Defects	Nationwide
5 Nov 2025Drug	CLASS II	Prazosin Hydrochloride, Capsules, USP, 1 mg recalledPrazosin Hydrochloride	Amerisource Health Services	Nitrosamine Impurity	Nationwide

Other Sucralfate recalls

All 6

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
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