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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

Ascend Laboratories LLC: Minocycline Hydrochloride Extended-Release Tablets Recalled for Failed Testing

Agency Publication Date: February 5, 2020
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Summary

Ascend Laboratories LLC is recalling 4,728 bottles of Minocycline Hydrochloride Extended-Release Tablets (105 mg), a prescription antibiotic used to treat various infections. The recall was initiated because the tablets failed dissolution testing, which means the medication may not dissolve at the correct rate to be properly absorbed by the body. This issue was identified during routine quality testing. Consumers should contact their healthcare provider or pharmacist for guidance regarding their treatment and return any remaining medication to their pharmacy.

Risk

The tablets failed to meet the required dissolution specifications, which could lead to lower-than-intended levels of the medication being absorbed into the bloodstream. This may result in the medication being less effective at treating the underlying infection.

What You Should Do

  1. Check your prescription bottle to see if you have Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg in a 30-count bottle with NDC 67877-438-30.
  2. Verify the specific batch by looking for Lot Number 19140414 with an expiration date of 12/2020.
  3. If your medication matches the affected lot, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription.
  4. Return any unused tablets from this specific lot to your pharmacy for a refund and further instructions from the manufacturer.
  5. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Healthcare consultation and product return.

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

Affected Products

Product: Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg (30-count bottle)
Model:
NDC 67877-438-30
Lot Numbers:
19140414 (Exp 12/2020)
Date Ranges: Expiration 12/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84750
Status: Resolved
Manufacturer: Ascend Laboratories LLC
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: 4728 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 · 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.