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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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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Torrent Pharma Inc: Anagrelide Capsules Recalled Due to Failed Dissolution Specifications

Agency Publication Date: December 1, 2020
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Summary

Approximately 2,496 bottles of Anagrelide Capsules (anagrelide USP), a prescription medication used to treat high platelet counts, are being recalled because the drug may not dissolve properly. When a medication fails dissolution specifications, it may not be absorbed by the body at the correct rate, which can lead to the treatment being less effective than intended. These 1 mg capsules were sold in 100-count bottles across the United States and Puerto Rico. Consumers should consult their healthcare provider or pharmacist for a replacement and to ensure their platelet levels remain managed.

Risk

The capsules failed dissolution testing, meaning the active medication may not release into the body as required. This can result in reduced drug efficacy, which may fail to properly manage platelet levels in patients who rely on this medication.

What You Should Do

  1. Identify the product by checking your prescription bottle for Anagrelide Capsules, USP 1 mg, in 100-count bottles with NDC 13668-462-01.
  2. Check the bottle label for Batch/Lot number BFD1G001 with an expiration date of 12/2021.
  3. Do not stop taking the medication without first consulting your doctor or pharmacist, as abruptly stopping a prescribed treatment can pose health risks.
  4. Contact your pharmacist or healthcare provider immediately to discuss a replacement and to return any affected product for a refund.
  5. Contact the manufacturer, Torrent Pharma Inc., or visit the distributor at 2091 Hartel Ave, Levittown, Pennsylvania, 19057-4506 for additional information regarding the recall.
  6. For further assistance or to report a related health issue, contact the FDA Consumer Complaint hotline at 1-888-SAFEFDA (1-888-723-3332).

Your Remedy Options

๐Ÿ’ฐFull Refund

Return unused product 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: Anagrelide Capsules, USP (1 mg, 100 capsules)
Model:
NDC 13668-462-01
Recall #: D-0166-2021
Lot Numbers:
BFD1G001 (Exp 12/2021)
Date Ranges: Expiration Date 12/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86878
Status: Resolved
Manufacturer: Torrent Pharma Inc
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 2496 Bottles
Distributed To: Nationwide
Agency Last Updated: December 16, 2020

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.