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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

Nostrum Laboratories Inc: Theophylline Extended-Release Tablets Recalled for Incorrect Lot and Expiration

Agency Publication Date: March 25, 2020
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Summary

Nostrum Laboratories Inc. is recalling 4,722 bottles of Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, which is a prescription medication used to treat asthma and other lung conditions. The recall was initiated because the product was incorrectly labeled with the wrong lot number and expiration date due to manufacturing errors. Consumers who rely on the expiration date for medication potency and safety may be using product that is not accurately tracked or could be older than indicated.

Risk

Incorrect labeling of expiration dates and lot numbers can lead to patients using medication beyond its intended shelf life, potentially resulting in reduced effectiveness or difficulty in tracking specific bottles if other safety issues arise.

What You Should Do

  1. Check your medication bottle for Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, in 100-count bottles with NDC 29033-001-01.
  2. Verify if your bottle belongs to Lot THE190501 with the labeled expiration date of 11/2022.
  3. If you have an affected bottle, contact your healthcare provider or pharmacist immediately for guidance on obtaining a replacement and to ensure your treatment is not interrupted.
  4. Return any unused portion of the affected medication to the pharmacy where it was purchased to receive a refund and ensure proper disposal.
  5. Contact Nostrum Laboratories Inc. directly at their Kansas City facility for further instructions regarding this recall.
  6. For additional questions or to report adverse effects, 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

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

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

Affected Products

Product: Theophylline (Anhydrous) Extended-Release Tablets, 400 mg (100-count bottle)
Model:
NDC 29033-001-01
Recall #: D-1059-2020
Lot Numbers:
THE190501 (Exp 11/2022)
Date Ranges: November 2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85235
Status: Resolved
Manufacturer: Nostrum Laboratories Inc
Manufactured In: United States
Units Affected: 4722 bottles
Distributed To: Tennessee, Missouri

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.