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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 30
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.
Related recalls
Same manufacturer · NATCO Pharma Limited
See all →- HighFDA Recalls Lansoprazole Delayed-Release Capsules Due to Manufacturing Defects
FDA (Drugs) · 2024-02-14
Same hazard · cgmp violation
See all →- Moderatevite20 Antifungal Cream recalled due to stability testing deviations
FDA (Drugs) · 2026-07-08
- ModerateNeuroquell products recalled over current good manufacturing practice violations
FDA (Drugs) · 2025-09-17
- ModerateOptim V Anti-Itch Cream Recalled for Current Good Manufacturing Practice Deviations
FDA (Drugs) · 2025-05-28
- ModerateNature Mint Anticavity Fluoride Toothpaste Recalled for CGMP Deviations
FDA (Drugs) · 2025-05-28
- ModerateRapidol Hydrocortisone 1% Anti-Itch Cream Recalled for CGMP Deviations
FDA (Drugs) · 2025-05-28
Similar recalls
- HighFDA Recalls Lansoprazole Delayed-Release Capsules Due to Manufacturing Defects
FDA (Drugs) · 2024-02-14
- ModerateWockhardt Recalls 15 mg Lansoprazole Capsules Due to CGMP Deviations
FDA (Drugs) · 2015-07-29
- ModerateWockhardt Recalls 15 mg Lansoprazole Capsules Due to Complaint Investigation Failures
FDA (Drugs) · 2015-07-29
- HighLansoprazole Capsules Recalled for Failed Dissolution in Stability Testing
FDA (Drugs) · 2022-04-06
- ModerateWockhardt Recalls Lansoprazole Capsules Due to Inadequate Complaint Investigation
FDA (Drugs) · 2015-07-29
- ModerateGSK Recalls Prevacid 24HR Capsules Due to Manufacturing Deviations
FDA (Drugs) · 2018-10-17