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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Teva Pharmaceuticals USA: Lansoprazole Delayed-Release Tablets Recalled for Subpotency

Agency Publication Date: March 15, 2019
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Summary

Teva Pharmaceuticals USA is recalling 7,081 bottles of Lansoprazole (Prevacid) Delayed-Release Orally Disintegrating Tablets, 15 mg, because the medication was found to be subpotent. This means the drug may not have the full strength required to effectively treat acid-related stomach conditions. The affected prescription medication was distributed nationwide in bottles containing 100 tablets (arranged in 10 blister cards). Consumers should contact their doctor or pharmacist to discuss alternative treatments, as this specific lot does not meet quality standards.

Risk

Because this medication is subpotent, it contains less active ingredient than specified, which can lead to ineffective treatment of conditions like acid reflux or stomach ulcers. While the risk of immediate harm is low, the failure to control stomach acid could lead to a return of symptoms or a worsening of the underlying condition.

What You Should Do

  1. Check your prescription bottle for Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg (100-count bottle).
  2. Look for Lot Number 25Q002 with an Expiration Date of 11/2019 and NDC 0093-3008-93 to see if your medication is affected.
  3. If you have the recalled medication, contact your healthcare provider or pharmacist for guidance on how to obtain a replacement and to ensure your treatment remains effective.
  4. Return any unused product from this specific lot to your pharmacy for a refund.
  5. Contact Teva Pharmaceuticals USA at 1-888-838-2872 for further instructions regarding this recall.
  6. For additional information, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmaceutical product return and consultation.

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 (10 blister cards of 10 tablets each)
Model:
NDC 0093-3008-93
Recall #: D-1006-2019
Lot Numbers:
25Q002 (Exp. 11/2019)
Date Ranges: Expiration 11/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82367
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA
Sold By: Pharmacies
Manufactured In: Israel, United States
Units Affected: 7,081 bottles
Distributed To: Nationwide

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.