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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/Topical Products

Lupin Pharmaceuticals Inc.: Testosterone Topical Solution Recalled Due to Defective Pump Containers

Agency Publication Date: March 19, 2019
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Summary

Lupin Pharmaceuticals Inc. is recalling 3,200 bottles of Testosterone Topical Solution (30mg/1.5mL) because the delivery pump may not work properly. The recall affects 110mL bottles from lot K700086 with an expiration date of November 2019. This defect was discovered following multiple complaints that the pump mechanism failed to dispense the medication as intended. Because this is a prescription drug, patients should consult their healthcare provider or pharmacist regarding their treatment and return the affected product for a refund.

Risk

A malfunctioning pump can prevent patients from receiving their prescribed dosage of testosterone or cause inconsistent dosing, which may lead to a lack of therapeutic effect. While no injuries have been reported, the repetitive failure of the container's delivery system compromises the reliability of the medication delivery.

What You Should Do

  1. Check your medication bottle to see if it is Testosterone Topical Solution, 30mg/1.5mL in a 110mL bottle with NDC 68180-943-11.
  2. Verify the lot information on the bottle label; this recall specifically affects Lot # K700086 with an expiration date of 11/2019.
  3. Contact your healthcare provider or pharmacist immediately for guidance if you have an affected bottle, as you may need a replacement prescription to ensure your treatment is not interrupted.
  4. Return any unused or defective product from the affected lot to your pharmacy to receive a refund.
  5. Contact Lupin Pharmaceuticals Inc. at their Baltimore, Maryland headquarters or through your dispensing pharmacy for further instructions regarding the return process.
  6. For additional questions or to report a complaint, 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: Testosterone Topical Solution, 30mg/1.5mL (110mL bottle)
Model:
NDC 68180-943-11
Recall #: D-1010-2019
Lot Numbers:
K700086 (Exp 11/2019)
Date Ranges: Expiration 11/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82392
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: wholesale/drug chain distributors; supermarket chain
Manufactured In: United States, India
Units Affected: 3,200 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.