Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Feb 1, 2024 (3 years ago)

Lansoprazole Delayed-Release Capsules USP

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

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.

Cause type: Packaging defect

Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.

What was recalled

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

Affected NDC 16571-0742-41

Compare with the code on your package — it is the most precise check available.

Drug: Lansoprazole

Recalling firm
NATCO Pharma Limited
NDC code
16571-742-41
Origin
India
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0318-2024 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Lansoprazole recalls

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Other recalls by NATCO Pharma Limited

All 2024 recalls