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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/Prescription Drugs

Dr. Reddy's Lansoprazole Delayed-Release Tablets Recalled for Failed Dissolution

Agency Publication Date: May 5, 2022
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Summary

Dr. Reddy's Laboratories, Inc. has voluntarily recalled 252 blister packs of Lansoprazole (lansoprazole) Delayed-Release Orally Disintegrating Tablets, 30 mg. The recall was issued because the tablets failed dissolution testing, which means the medication may not break down and be absorbed by the body as intended. No incidents or injuries related to this issue have been reported to date.

Risk

If the tablets fail to dissolve properly, the medication may not be fully absorbed, potentially resulting in ineffective treatment of gastric conditions like acid reflux or ulcers. No illnesses or adverse events have been reported.

What You Should Do

  1. The recalled product is Dr. Reddy's Lansoprazole (lansoprazole) Delayed-Release Orally Disintegrating Tablets, 30 mg, sold in 100-count blister packs under NDC 43598-561-78.
  2. This recall affects Lot # T2000645 with an expiration date of July 2022 (Exp 07/2022).
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Dr. Reddy's Laboratories, Inc. 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 Orally Disintegrating Tablets (30 mg, 100-count)
Variants: 30 mg, Orally Disintegrating Tablets, 100 Tablets per blister pack
Lot Numbers:
T2000645 (Exp 07/2022)
NDC:
43598-561-78

Recall #: D-0853-2022. Distributed by: Dr. Reddy's Laboratories, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90021
Status: Resolved
Manufacturer: Dr. Reddy's Laboratories, Inc.
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 252 Blister Packs
Distributed To: Ohio

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.