FDA Recalls Lansoprazole Delayed-Release Capsules for Manufacturing Practice Deviations
NATCO Pharma Limited is voluntarily recalling 30 bottles of Lansoprazole 15 mg delayed-release capsules due to Current Good Manufacturing Practice deviations. The product was distributed nationwide in the United States.
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: The recall is classified as FDA Class II and was voluntarily initiated by the manufacturer due to CGMP deviations. No illnesses, injuries, or deaths have been reported in association with this product. Per the rubric, FDA Class II recalls without reported hospitalization or illness reports, particularly voluntary precautionary recalls, are classified as Moderate.
Plain-English summary
NATCO Pharma Limited is recalling Lansoprazole Delayed-Release Capsules USP, 15 mg, a medication used to treat frequent heartburn. Each bottle contains 14 capsules. The recalled lot is Lot #411988 with an expiration date of May 31, 2025; a total of 30 bottles were affected.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. This is a Class II recall, voluntarily initiated by the firm on March 27, 2024, and was terminated on February 6, 2026.
The product was distributed nationwide in the United States through Rising Pharma Holdings, Inc., based in East Brunswick, New Jersey. The product was manufactured by NATCO Pharma Limited in Kothur, India.
The recalled product
- Product
- Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
- Manufacturer
- NATCO Pharma Limited
- Category
- Drug — Heartburn / Acid Reducer
- Hazard
- cgmp-violation
- manufacturing-defect
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 (2)
- Lot#: 411988
- Exp date: 05/31/2025
Distribution
Distributed nationwide across the United States.
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