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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

Lupin Pharmaceuticals Inc.: Duloxetine Delayed-Release Capsules Recalled for Failed Dissolution Tests

Agency Publication Date: November 28, 2017
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Summary

Lupin Pharmaceuticals Inc. is recalling 111,648 units of Duloxetine Delayed-Release Capsules USP (30 mg), a prescription medication used to treat depression and anxiety. The recall was initiated because the product failed to meet dissolution specifications during testing, which means the medication may not release properly in the body. Consumers who have these 30-count bottles should contact their healthcare provider or pharmacist for guidance regarding their treatment.

Risk

If a delayed-release medication fails to dissolve as intended, it may release the active ingredient too early or too late, potentially reducing the effectiveness of the drug or causing unexpected side effects.

What You Should Do

  1. Check your prescription bottle for Duloxetine Delayed-Release Capsules USP, 30 mg in 30-count bottles.
  2. Locate the Lot number and expiration date on the side of the bottle label. This recall specifically affects Lot #: G602051 with an expiration date of 12/2017.
  3. Verify the NDC number (68180-295-06) and UPC (368180295068) on the packaging to confirm if your medication is part of the recall.
  4. Contact your healthcare provider or pharmacist immediately for guidance on whether you should continue taking the medication or if you need a replacement prescription.
  5. Return any unused portions of the affected medication to your pharmacy to receive a refund.
  6. For further instructions, contact the manufacturer, Lupin Pharmaceuticals Inc., or for general questions regarding FDA drug recalls, call the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare consultation and pharmacy refund

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

Affected Products

Product: Duloxetine Delayed-Release Capsules USP, 30 mg (30-count bottles)
Model:
NDC 68180-295-06
Recall #: D-0097-2018
UPC Codes:
368180295068
Lot Numbers:
G602051 (Exp. 12/2017)
Date Ranges: Expiration Date 12/2017

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78596
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: pharmacies; healthcare providers
Manufactured In: United States, India
Units Affected: 111,648 units
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.