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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

B & B Pharmaceuticals, Inc.: Estradiol (USP) Recalled for Potential Teflon Particle Contamination

Agency Publication Date: April 16, 2020
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Summary

B & B Pharmaceuticals, Inc. has recalled 3,825 grams of Estradiol (USP), a non-micronized hemihydrate medication used in hormone therapy. The recall was initiated because foreign material (Teflon) was introduced into the product during the manufacturing process due to equipment deviations. This recall affects three specific package sizes: 25 grams, 100 grams, and 500 grams, all distributed nationwide in the United States. Consumers who have these products should stop using them and contact their healthcare provider or pharmacist immediately.

Risk

The presence of foreign materials like Teflon in medication can cause physical irritation or unintended chemical exposure if consumed or processed into other medications. This contamination occurred at the production level due to manufacturing deviations.

What You Should Do

  1. Check your medication container for the product name 'Estradiol, USP (Non-Micronized) (Hemihydrate)' and identify the packaging size: 500 grams (NDC 63275-9900-8), 100 grams (NDC 63275-9900-5), or 25 grams (NDC 63275-9900-4).
  2. Locate the Lot Number on the label; the affected product is marked with Lot #: 18K26-BB02-PR00553 and may have a Reassay date of 10/09/2023.
  3. Verify if the container includes Product numbers 700365, 700362, or 700363.
  4. If your product matches these identifiers, stop using it immediately and do not use it for compounding or further manufacturing.
  5. Contact your healthcare provider or pharmacist for guidance regarding your treatment and return any unused product to the place of purchase for a refund.
  6. Contact B&B Pharmaceuticals, Inc. at 800-499-3100 for further instructions regarding the return or disposal of the affected material.
  7. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse events.

Your Remedy Options

๐Ÿ’ฐFull Refund

Refund and guidance from healthcare provider.

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

Affected Products

Product: Estradiol, USP (Non-Micronized) (Hemihydrate) (500 grams)
Model:
NDC 63275-9900-8
Product # 700365
Lot Numbers:
18K26-BB02-PR00553 (Reassay 10/09/2023)
Date Ranges: Reassay 10/09/2023
Product: Estradiol, USP (Non-Micronized) (Hemihydrate) (100 grams)
Model:
NDC 63275-9900-5
Product # 700362
Lot Numbers:
18K26-BB02-PR00553 (Reassay 10/09/2023)
Date Ranges: Reassay 10/09/2023
Product: Estradiol, USP (Non-Micronized) (Hemihydrate) (25 grams)
Model:
NDC 63275-9900-4
Product # 700363
Lot Numbers:
18K26-BB02-PR00553 (Reassay 10/09/2023)
Date Ranges: Reassay 10/09/2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85440
Status: Resolved
Manufacturer: B & B Pharmaceuticals, Inc.
Sold By: B&B Pharmaceuticals, Inc.
Manufactured In: United States
Units Affected: 3,825 grams
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.