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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

Zydus Pharmaceuticals (USA) Inc: Lansoprazole Delayed-Release Tablets Recalled for Failed Dissolution

Agency Publication Date: December 11, 2020
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Summary

Zydus Pharmaceuticals (USA) Inc. is recalling approximately 37,992 cartons of Lansoprazole Delayed-Release Orally Disintegrating Tablets (15 mg and 30 mg) because the medication failed to meet dissolution specifications during testing. This prescription drug, used to treat stomach acid conditions, may not break down properly in the body, which can prevent the patient from receiving the full intended dose of the medication. Consumers who have these tablets should contact their healthcare provider or pharmacist for guidance on continuing their treatment.

Risk

The tablets failed to dissolve at the required rate, which means the medication may not be absorbed correctly by the body. This could lead to a decrease in the drug's effectiveness, potentially resulting in inadequately managed acid-related gastrointestinal symptoms.

What You Should Do

  1. Check your prescription bottle or blister pack for the product name Lansoprazole Delayed-Release Orally Disintegrating Tablets in 15 mg or 30 mg strengths.
  2. For 15 mg tablets (NDC 68382-771-77), verify if your pack matches lot M915744 (Exp. OCT 2021) or lot M904770 (Exp. FEB 2021).
  3. For 30 mg tablets (NDC 68382-772-77), verify if your pack matches lot M900412 (Exp. December 2020), lot M904772 (Exp. February 2021), or lot M915745 (Exp. October 2021).
  4. If you identify an affected product, contact your healthcare provider or pharmacist immediately to discuss a replacement prescription or alternative treatment.
  5. Return any unused portions of the recalled medication to the pharmacy where it was purchased for a refund and further instructions.
  6. Contact Zydus Pharmaceuticals (USA) Inc. at their Pennington, New Jersey office for additional information regarding this recall.
  7. For further questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack
Model:
NDC 68382-771-77
Recall #: D-0145-2021
Lot Numbers:
M915744 (OCT 2021)
M904770 (FEB 2021)
Product: Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10 unit-dose) blister pack
Model:
NDC 68382-772-77
Recall #: D-0146-2021
Lot Numbers:
M900412 (December 2020)
M904772 (February 2021)
M915745 (October 2021)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86925
Status: Resolved
Manufacturer: Zydus Pharmaceuticals (USA) Inc
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 2 products (15,144 cartons; 22,848 cartons)
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.