Lansoprazole Delayed-Release Capsules USP recall
FDA recall D-0318-2024 · initiated Feb 1, 2024
NATCO Pharma Limited recalled Lansoprazole Delayed-Release Capsules USP in Feb 2024 — an FDA Class II recall (D-0318-2024) because CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4260 bottles
Details
- 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
- Recalling company
- Natco Pharma USA
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Feb 1, 2024
- FDA report date
- Feb 14, 2024
Frequently asked
- Was Lansoprazole Delayed-Release Capsules USP recalled?
- NATCO Pharma Limited recalled Lansoprazole Delayed-Release Capsules USP in Feb 2024 — an FDA Class II recall (D-0318-2024) because CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Lansoprazole Delayed-Release Capsules USP recalled?
- Per the FDA enforcement record, the reason for recall D-0318-2024 was: CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
- Is a recalled Lansoprazole Delayed-Release Capsules USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Lansoprazole Delayed-Release Capsules USP are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot # 411987 Exp: 05/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0318-2024.