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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

Glenmark Theophylline Extended-Release Tablets Recalled for Dissolution Issues

Agency Publication Date: May 28, 2025
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Summary

Glenmark Pharmaceuticals Inc., USA is recalling 8,520 bottles of Theophylline (Anhydrous) Extended-Release Tablets, 600 mg. This recall was initiated after testing revealed that the tablets failed a dissolution test, meaning the medication may not release into the body as intended. Consumers should contact their healthcare provider or pharmacist to discuss their treatment and determine if they have the affected medication.

Risk

If an extended-release medication fails to dissolve properly, it may release the drug too slowly, making it ineffective, or too quickly, which could lead to toxic levels of the medication in the bloodstream. This is particularly concerning for theophylline, which requires precise dosing to treat respiratory conditions safely.

What You Should Do

  1. This recall affects Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, sold in 100-count bottles under NDC 68462-356-01.
  2. Check your prescription bottle for the following lot numbers and expiration dates: Lots 19234121 and 19234148 (Exp Sep-30-25), or Lots 19242881 and 19242899 (Exp Jun-30-26).
  3. If you have health concerns or are unsure if your medication is affected, contact your healthcare provider or pharmacist immediately.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact Glenmark Pharmaceuticals Inc., USA for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have further questions or wish to report an issue.

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: Theophylline (Anhydrous) Extended-Release Tablets, 600 mg (100-count bottle)by Glenmark
Variants: 600 mg, Extended-Release, Tablet
Lot Numbers:
19234121 (Exp Sep-30-25)
19234148 (Exp Sep-30-25)
19242881 (Exp Jun-30-26)
19242899 (Exp Jun-30-26)
NDC:
68462-356-01

Rx Only; Manufactured by Glenmark Pharmaceuticals Limited in India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96867
Status: Active
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Sold By: Pharmacies; Wholesalers
Manufactured In: India
Units Affected: 8,520 100-count 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.