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Class II Recall — Risk of Temporary or Reversible Adverse Health Consequences
Verified · FDAClass II — Possible RiskMedications

NATCO Pharma Limited Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured Recall 2024

NATCO Pharma LimitedIssued February 1, 2024

NATCO Pharma Limited 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. — recalled per FDA on 2/1/2024. Reason: 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..

Issuing agency
FDA
Issued
Feb 1, 2024
Brand
NATCO Pharma Limited
Distribution
1 states

What to do right now

  1. 1

    Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. 2

    Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. 3

    Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

Verified source

U.S. Food and Drug Administration

Summary of the official FDA notice issued February 1, 2024. Last synced Apr 27, 2026. View on fda.gov

What's 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

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.

Affected products & lot numbers
1 lot called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Lot # 411987 Exp: 05/2025
Where was it sold
1 state

Nationwide in the USA

nationwide
View official FDA notice

View all questions for this recall →

More recalls like this
4 related — by brand, contaminant, and category

Frequently asked questions

Is the NATCO Pharma Limited recall still active?

Yes, this recall is currently active as of February 1, 2024. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot # 411987 Exp: 05/2025. Check the label on your product.

What should I do if I have the recalled NATCO Pharma Limited?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.