Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (NDC 63275-9900-4), Distributed by B&B Pharmaceuticals, Inc. 800-499-3100

Class I - Dangerous
💊 Drugs Recalled: April 14, 2020 B & B Pharmaceuticals Other Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #: 18K26-BB02-PR00553, Reassay 10/09/2023 Product # 700365, 700362 & 700363
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
B & B Pharmaceuticals, Inc.
Reason for Recall:
cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (NDC 63275-9900-4), Distributed by B&B Pharmaceuticals, Inc. 800-499-3100

Product Codes/Lot Numbers:

Lot #: 18K26-BB02-PR00553, Reassay 10/09/2023 Product # 700365, 700362 & 700363

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1244-2020