Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Estradiol Recalled by B & B Pharmaceuticals, Inc. Due to Foreign Object Contamination

Date: April 14, 2020
Company: B & B Pharmaceuticals, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact B & B Pharmaceuticals, Inc. directly.

Affected Products

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

Quantity: 3,825 grams

Why Was This Recalled?

cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About B & B Pharmaceuticals, Inc.

B & B Pharmaceuticals, Inc. has 1 total recall tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report