Reported Apr 22, 2020 · Terminated

Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC…

B & B Pharmaceuticals, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: B & B Pharmaceuticals, Inc. · 8591 Prairie Trail Dr Ste C600 · Englewood, CO · 80112-7075

Is this the product you have?

  • 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
Lot codes and dates
    • Lot #: 18K26-BB02-PR00553
    • Reassay 10/09/2023 Product # 700365
    • 700362 & 700363
Amount recalled
3,825 grams

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new foreign material recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jul 24, 2020 · Data as of Sep 19, 5:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.