A recall is active for Sucralfate Tablets, USP 1 gram distributed by American Health Packaging. The firm filed for Chapter 11 in September 2024, triggering CGMP deviations and questions about product identity, strength, quality and purity. The recall affects 26,992 blister packs distributed nationwide. Stop using the product and contact Amerisource Health Services or your clinician for guidance.
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.
Consumers and healthcare providers should stop using this product immediately. Contact Amerisource Health Services LLC or your healthcare provider for guidance. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Sucralfate tablets are used to treat ulcers and gastritis by creating a protective barrier in the stomach.
CGMP deviations mean the product identity, strength, quality and purity cannot be assured, potentially exposing patients to adulterated medication.
This recall is not described as part of a broader industry pattern in the summary.
Consumers may face ineffective treatment due to adulterated product and potential safety concerns; affected patients should contact providers for guidance.
FDA recall page and enforcement report D-0598-2025 at accessdata.fda.gov
Refunds or replacements coordinated by Amerisource Health Services LLC; timelines not specified
Keep recall notification letters, product packaging, lot numbers, and correspondence with healthcare providers
Product: Sucralfate Tablets, USP 1 gram, 100 tablets per package (10x10). Distributor: American Health Packaging, Columbus, OH 43217. NDC 60687-695-01 carton; Unit Dose NDC 60687-695-11. Quantity recalled: 26,992 blister packs. Distribution: Nationwide. Classification: Class II. Recall date: 2025-07-29. Status: Active.
No specific injuries or incidents are described in the notice. The recall notice uses regulatory language rather than incident counts.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Meclizine Hydrochloride Tablets distributed nationwide by Amerisource Health Services LLC are being recalled. The two affected NDCs are 60687-775-65 and 60687-775-11. The recall is due to failed tablet specifications. Stop using the product and contact a healthcare provider for guidance immediately.
KVK-Tech Inc. recalled 31,676 packages of Oxycodone Hydrochloride Tablets on January 14, 2026. Defective seals may cause tablets to fall out, posing a health risk. Customers should stop using the product immediately and seek guidance from healthcare providers.
27,868 blister packs of Sucralfate Tablets, 1 g, distributed nationwide by American Health Packaging are recalled. The recall stems from CGMP deviations that prevent the firm from assuring product identity, strength, quality and purity. Health providers and consumers should stop using the product immediately and await guidance.
FDA recalls Carbamazepine Extended-Release Tablets, 400 mg, distributed nationwide by American Health Packaging. The recall cites failed dissolution specifications and class II classification. Consumers should stop using and contact healthcare providers for guidance.
A recall of chlorpromazine hydrochloride tablets is active nationwide in the United States. A specific lot of packaging material to coils used in manufacturing contained a foreign substance with a microorganism detected. Tablets themselves tested negative for microorganisms. Consumers and healthcare providers should stop using the product immediately and contact Amerisource Health Services LLC or
Chlorpromazine Hydrochloride tablets distributed nationwide by American Health Packaging are recalled after a polyester coil used in packaging showed presence of a micro-organism in a specific lot. No tablets were contaminated. Consumers and healthcare providers should stop using this product immediately and contact Amerisource Health Services LLC for guidance.
American Health Packaging recalled 873 cartons of Chlorpromazine Hydrochloride Tablets, USP, 200 mg, after foreign substances were detected in product packaging. A specific lot of auxiliary polyester coil contained a micro-organism, posing a high health risk. Consumers should stop using the product immediately and contact their healthcare provider for guidance.
A high-severity recall covers chlorpromazine hydrochloride tablets distributed nationwide by American Health Packaging. A foreign substance linked to a polyester coil packaging component was detected at the manufacturing site. No tablets were contaminated. Stop using the product and contact the distributor for guidance.