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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

Teva Pharmaceuticals USA: Dutasteride and Tamsulosin HCl Capsules Recalled for Failed Dissolution

Agency Publication Date: November 2, 2017
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Summary

Teva Pharmaceuticals USA is recalling approximately 140,993 bottles of Dutasteride and Tamsulosin HCl Capsules (0.5 mg/0.4 mg) because the medication may not dissolve properly. These prescription capsules, which are used to treat symptoms of an enlarged prostate, were distributed in 30-count and 90-count bottles nationwide and in Puerto Rico. If the medication does not dissolve as intended, it may not be absorbed correctly by the body, potentially reducing the effectiveness of the treatment.

Risk

The drug failed dissolution specifications, meaning the active ingredients may not be released into the body at the correct rate or amount. This can lead to a decrease in the drug's therapeutic effect, failing to manage the patient's condition as expected.

What You Should Do

  1. Check your prescription bottle for the product name 'Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg'.
  2. Identify if your medication is affected by checking the NDC and lot numbers. For 30-count bottles (NDC 0591-3771-30), look for lot numbers 1089376A, 1089382A, 1095210M, 1117768M, 1117769A (Exp. 11/17) or 1128452A, 1128453A, 1137658A, 1154207A, 1156087A (Exp. 03/18).
  3. For 90-count bottles (NDC 0591-3771-19), look for lot numbers 1089379A, 1091533M, 1125206A (Exp. 11/17) or 1128456A, 1147665A, 1154208A, 1156088A (Exp. 03/18).
  4. Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if you have an affected bottle.
  5. Return any unused or affected medication to your pharmacy to receive a refund.
  6. Contact Teva Pharmaceuticals USA or the distributor, Actavis Pharma, at the contact information provided on your prescription label for further instructions regarding the return process.
  7. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance or to report adverse effects.

Your Remedy Options

💰Full Refund

Return product to 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: Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg (30-count bottle)
Model:
NDC 0591-3771-30
Lot Numbers:
1089376A (Exp. 11/17)
1089382A (Exp. 11/17)
1095210M (Exp. 11/17)
1117768M (Exp. 11/17)
1117769A (Exp. 11/17)
1128452A (Exp. 03/18)
1128453A (Exp. 03/18)
1137658A (Exp. 03/18)
1154207A (Exp. 03/18)
1156087A (Exp. 03/18)
Date Ranges: Exp. 11/17, Exp. 03/18
Product: Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg (90-count bottle)
Model:
NDC 0591-3771-19
Lot Numbers:
1089379A (Exp. 11/17)
1091533M (Exp. 11/17)
1125206A (Exp. 11/17)
1128456A (Exp. 03/18)
1147665A (Exp. 03/18)
1154208A (Exp. 03/18)
1156088A (Exp. 03/18)
Date Ranges: Exp. 11/17, Exp. 03/18

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78364
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 140,993 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 · 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.