Unrated Drug recall · FDA · Published April 14, 2020

B & B Pharmaceuticals Recalls Estradiol Due to Teflon Foreign Material

B & B Pharmaceuticals recalls estradiol products containing foreign Teflon material from specific lots. Consumers should contact the company for details on affected products and next steps.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1244-2020Drug B & B Pharmaceuticals ›

Recall notice

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

Take action

Contact the company

Recalling firmB & B Pharmaceuticals, Inc.8591 Prairie Trail Dr Ste C600 · Englewood, CO 80112-7075

✎ GovInfoNow plain-language explainer

B & B Pharmaceuticals is recalling estradiol products that contain Teflon foreign material from production. This could pose a risk of injury if the material is ingested or causes allergic reactions. The recall affects specific lot numbers and package sizes. Read more at govinfonow.com/recall/37146-b-b-pharmaceuticals-recalls-estradiol-due-to-teflon-foreign-material.

Source Summary by GovInfoNow · govinfonow.com/recall/37146-b-b-pharmaceuticals-recalls-estradiol-due-to-teflon-foreign-material · Updated October 5, 2026 · FDA enforcement record: FDA #D-1244-2020

Cite this page

“B & B Pharmaceuticals Recalls Estradiol Due to Teflon Foreign Material.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37146-b-b-pharmaceuticals-recalls-estradiol-due-to-teflon-foreign-material. Based on FDA recall #D-1244-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1244-2020%22&limit=1).

B & B Pharmaceuticals, Inc. recalled Estradiol, USP (Non-Micronized) (Hemihydrate) due to cGMP deviations involving foreign Teflon material, the FDA said on April 14, 2020. The Class II recall was voluntarily initiated by the firm.

How to tell if you have it

Brand: B & B Pharmaceuticals
Product: Estradiol, USP (Non-Micronized) (Hemihydrate)
NDC 63275-9900-8, 500 grams
NDC 63275-9900-5, 100 grams
NDC 63275-9900-4, 25 grams
Lot #: 18K26-BB02-PR00553
Product # 700365, 700362 & 700363

The hazard

The recall addresses cGMP deviations where foreign material, specifically Teflon, was introduced at the production level. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show other recent recalls of similar products include Teva Clonidine Transdermal System Recall (2026-03-19), Asteria Health ESTRADIOL 20mg Pellet Recall (2026-01-26), and Golden State Baclofen Tablets Recall (2025-11-26).

How to tell if you have this one

Check the product label for NDC numbers 63275-9900-8, 63275-9900-5, or 63275-9900-4. The affected lot number is 18K26-BB02-PR00553.

Brand
B & B Pharmaceuticals
Category
Drug

Based on the official FDA remedy

What to do — step by step

Contact Manufacturer
Reach out to B & B Pharmaceuticals at 800-499-3100 for details on affected products and next steps.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3 months after the firm started it.

Apr 14, 2020Firm started the recall
Apr 16, 2020FDA classified it Class II
Apr 22, 2020Published in FDA’s Enforcement Report
Jul 24, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/37146-b-b-pharmaceuticals-recalls-estradiol-due-to-teflon-foreign-material">B &amp; B Pharmaceuticals Recalls Estradiol Due to Teflon Foreign Material (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-1244-2020 (April 14, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1244-2020 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.