Sucralfate tablets recalled after bankruptcy left quality program unmonitored
Amerisource Health Services is recalling 27,868 blister packs of Sucralfate Tablets USP 1 gram because, after a Chapter 11 filing, the firm cannot monitor its quality program.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 as a precautionary quality-system action: the record cites an inability to assure quality after a bankruptcy filing, without identifying any defect in the product or reporting harm.
Plain-English summary
Sucralfate Tablets, USP 1 gram, in 100-tablet (10x10) blister packs distributed by American Health Packaging of Columbus, Ohio, are being recalled for CGMP deviations.
The recalling firm filed for Chapter 11 on 30 September 2024. As a result it cannot monitor the quality program and so cannot assure that products meet the identity, strength, quality and purity characteristics they are purported or represented to possess, which renders the products adulterated.
The recall covers 27,868 blister packs from lots 1017392 (expiring 31 January 2026) and 1017415 (expiring 31 December 2025), carrying NDC 60687-695-01. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
The enforcement record identifies no specific defect in the tablets themselves and reports no injuries. Patients holding an affected lot should contact their pharmacy or prescriber about a replacement rather than stopping treatment on their own.
The recalled product
- Product
- 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]
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug — Gastrointestinal
- Affected units
- 27,868
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 1017392
- Exp. Date 01/31/2026
- 1017415
- Exp. Date 12/31/2025.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Amerisource Health Services LLC
See all →- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets 50 mg Recalled for API Cross-Contamination
FDA (Drugs) · 2026-05-27
- HighMeclizine hydrochloride 12.5 mg tablets recalled after failing tablet specifications
FDA (Drugs) · 2026-04-01
- HighOxycodone blister cards recalled over seals that let tablets fall out
FDA (Drugs) · 2026-02-18
- HighUnit dose prazosin 2 mg cartons recalled over nitrosamine impurity
FDA (Drugs) · 2025-11-05
Same hazard · cgmp deviation
See all →- SevereZicam Cold Remedy Nasal Swabs Recalled for Microbiological Testing Failures
FDA (Drugs) · 2026-09-02
- ModerateGolden State Medical Supply Recalls Carbamazepine Tablets Due to CGMP Deviations
FDA (Drugs) · 2026-08-26
- ModerateSildenafil Citrate USP Recalled for CGMP Deviations Noted During FDA Inspection
FDA (Drugs) · 2026-08-19
- ModerateSildenafil Citrate Recall Due to CGMP Deviations
FDA (Drugs) · 2026-08-19
- SevereShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19