FDA Recalls Lansoprazole Delayed-Release Capsules Due to Manufacturing Defects
The FDA is recalling Lansoprazole Delayed-Release Capsules USP 15 mg due to manufacturing defects including inadequate sealing, capsule damage, and missing product codes. Affected lot 411987 was distributed nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with manufacturing quality deviations affecting seal integrity, capsule structure, and product labeling. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score as High.
Plain-English summary
Lansoprazole Delayed-Release Capsules USP, 15 mg (Lot 411987, expiration 05/2025) manufactured by NATCO Pharma Limited and distributed by Rising Pharma Holdings, Inc. is being recalled. The recall affects 4,260 bottles distributed nationwide in the United States.
The recall was issued due to current Good Manufacturing Practice (CGMP) deviations identified in production. Manufacturing defects include inadequate induction sealing on bottles, capsules with bubbles or holes on the band seal, and foreign spherical material adhering to capsules. Coding information was also missing from one bottle.
These defects could compromise medication integrity and stability. Consumers with this medication should check their lot number against 411987 and contact their pharmacy or healthcare provider if they have questions about whether their supply is from the affected lot.
The recalled product
- Product
- Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count 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
- Affected units
- 4,260
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 (1)
- Lot # 411987 Exp: 05/2025
Distribution
Distributed nationwide across the United States.
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