Lower risk Drug recall · FDA · Published January 10, 2020

Letco Medical Estriol USP Micronized Recall: Subpotent Risk

Letco Medical recalls specific estriol USP micronized products due to subpotent risk. Affected lots and sizes include 100 gm, 1 gm, 1 kg, and 25 gm NDCs. No remedy provided in official notice.

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

🇺🇸 FDA recall #D-0780-2020Drug Letco Medical ›

Lower-risk recall

Subpotent

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Contact the company

Recalling firmLetco Medical LLC1316 Commerce Dr · Decatur, AL 35601-7539

✎ GovInfoNow plain-language explainer

Letco Medical is recalling specific estriol USP micronized products that may be subpotent. This means the product might not contain enough active ingredient for intended use, potentially affecting treatment effectiveness. Read more at govinfonow.com/recall/37477-letco-medical-estriol-usp-micronized-recall-subpotent-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/37477-letco-medical-estriol-usp-micronized-recall-subpotent-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0780-2020

Cite this page

“Letco Medical Estriol USP Micronized Recall: Subpotent Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37477-letco-medical-estriol-usp-micronized-recall-subpotent-risk. Based on FDA recall #D-0780-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0780-2020%22&limit=1).

Letco Medical LLC recalled Estriol USP Micronized due to subpotency hazards, according to the FDA on Jan. 10, 2020. The voluntary Class II recall affects multiple lot codes distributed in the United States and other countries.

How to tell if you have it

Brand: Letco Medical
Product: Estriol USP Micronized
NDCs: 62991-2159-04, 62991-2159-01, 62991-2159-06, 62991-2159-03, 62991-2159-05, 62991-2159-02
Lots: 1804030048, 1712270019, 1802160017, 1804300021, 1806270007, 1808090056, 1904290047, 1810190004, 1812200072, 1901250024, 1902190028, 1907260018, 1804030049, 1712270020, 1802160018, 1804300022, 1806270008, 1808090057, 1904290048, 1810190005, 1812200073, 1901250025, 1902190029, 1907260019, 1802160022, 1810190009, 1812200077, 1907260023, 1804030050, 1712270021, 1802160019, 1804300023, 1806270009, 1808090058, 1904290049, 1810190006, 1812200074, 1901250026, 1902190030, 1907260020, 1802160021, 1804300025, 1806270011, 1808090060, 1810190008, 1812200076, 1901250028, 1902190031, 1907260022, 1712270022, 1802160020, 1804030051, 1804300024, 1806270010, 1808090059, 1810190007, 1812200075, 1901250027, 1904290050, 1907260021
Distribution: United States, Australia, Canada, Israel, Philippines, Taiwan

The hazard

The recalled Estriol USP Micronized is subpotent. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Letco Medical LLC has one other recall on record since Sept. 12, 2025, specifically the Espumil Foam Base Recall for labeling issues. Other recent recalls of similar products include Gasco Isopropyl Alcohol 70% Recall (May 29, 2026), Specialty Process Labs Thyroid Product Recall (Jan. 16, 2026), and Gasco Industrial Isopropyl Alcohol 70% Recall (May 29, 2026).

How to tell if you have this one

Check for the product names: Estriol USP Micronized. Look for NDC numbers 62991-2159-01 through 62991-2159-06 and specific expiration dates listed in the recall notice.

Brand
Letco Medical
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the NDC number and expiration date on your estriol USP micronized product to see if it matches the recalled items listed in the notice.

How this recall unfolded

Recall timeline

FDA terminated this recall 15 months after the firm started it.

Jan 10, 2020Firm started the recall
Jan 15, 2020FDA classified it Class II
Jan 22, 2020Published in FDA’s Enforcement Report
Apr 7, 2021FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this product safe to use?

The recall states the product may be subpotent, meaning it might not contain enough active ingredient. It is not safe to use as intended without verification.

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Link to this recall

<a href="https://govinfonow.com/recall/37477-letco-medical-estriol-usp-micronized-recall-subpotent-risk">Letco Medical Estriol USP Micronized Recall: Subpotent Risk (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-0780-2020 (January 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0780-2020 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.