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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Over-the-Counter

Rising Pharma Lansoprazole Delayed-Release Capsules Recalled for Sealing Defects

Agency Publication Date: February 8, 2024
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Summary

Rising Pharma Holdings, Inc. is recalling 4,260 bottles of Lansoprazole (15 mg) delayed-release capsules manufactured by Natco Pharma Limited. The recall was initiated due to several manufacturing defects, including improperly sealed bottles, capsules with holes, bubbles on the capsule seals, and some bottles missing required expiration and lot coding information. These defects were discovered during a quality review and affect the 14-count bottles of the medication.

Risk

Inadequate bottle seals and holes in capsules can expose the medication to air and moisture, which may cause the drug to break down and become less effective. Additionally, compromised packaging could lead to potential contamination, posing a risk to patients relying on the medication for heartburn treatment.

What You Should Do

  1. This recall affects 14-count bottles of Lansoprazole Delayed-Release Capsules USP (15 mg) sold under the Rising Pharma label with NDC 16571-742-41 and lot number 411987 (Exp: 05/2025).
  2. If you have health concerns regarding the use of this medication, contact your healthcare provider or pharmacist.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact Rising Pharma Holdings or Natco Pharma Limited for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Lansoprazole Delayed-Release Capsules USP (15 mg, 14-count bottle)
Variants: 15 mg, 14-count bottle
Lot Numbers:
411987 (Exp: 05/2025)
NDC:
16571-742-41

Manufactured by Natco Pharma Limited; Distributed by Rising Pharma Holdings, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93868
Status: Resolved
Manufacturer: NATCO Pharma Limited
Sold By: Pharmacies; Drug stores; Retailers
Manufactured In: India
Units Affected: 4260 bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.