Lower risk Drug recall · FDA · Published December 11, 2019

Spectrum Estriol Micronized: Subpotent Drug Risk

Spectrum Laboratory Products recalls estriol micronized products due to subpotent drug levels. The product may not deliver intended hormone effects. Affected lots expired by April 2021.

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

🇺🇸 FDA recall #D-0628-2020Drug Spectrum Laboratory Products ›

Lower-risk recall

Subpotent Drug: Supplier indicated assay results did not meet specifications.

Take action

Contact the company

Recalling firmSpectrum Laboratory Products14422 S San Pedro St · Gardena, CA 90248-2027

✎ GovInfoNow plain-language explainer

Spectrum Laboratory Products is recalling estriol micronized products because the drug content is lower than specified. This means the product may not work as intended for hormone replacement therapy. Read more at govinfonow.com/recall/37658-spectrum-estriol-micronized-subpotent-drug-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/37658-spectrum-estriol-micronized-subpotent-drug-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0628-2020

Cite this page

“Spectrum Estriol Micronized: Subpotent Drug Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37658-spectrum-estriol-micronized-subpotent-drug-risk. Based on FDA recall #D-0628-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0628-2020%22&limit=1).

The FDA announced on 2019-12-11 that Spectrum Laboratory Products voluntarily recalled Estriol Micronized, USP due to subpotent drug risks. Supplier assay results did not meet specifications for the product distributed nationwide in the USA and Canada.

How to tell if you have it

Brand: Spectrum Laboratory Products
Product: Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP
CAS: 50-27-1
Packaging: 1 G glass bottles, 5 G glass bottles, 25 G glass bottles, 100 G glass bottles, 500 G glass bottles, 1 KG plastic bottles
Lot codes: 1HG0308, 1HH0630, 1HI0854, 4HL0005, 4HL0036, 4IH0032
Expiration date: 04/16/2021
Manufacturer location: Spectrum Chemical Mfg Corp., Gardena, CA 90248

The hazard

The recall was issued because the supplier indicated that assay results for the Estriol Micronized did not meet specifications, resulting in a subpotent drug. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Spectrum Laboratory Products has three other recalls on record since 2014-07-18. Other recent recalls of similar products include Specialty Process Labs Thyroid Product Recall (2026-01-16), CoValence Laboratories Skin Rehab Gel Recall (2026-03-18), and Major Pharmaceuticals Levothyroxine Tablets Recall (2026-07-13).

How to tell if you have this one

Check for glass bottles labeled '1 G', '5 G', '25 G', '100 G', '500 G', or '1 KG' with the lot numbers 1HG0308, 1HH0630, 1HI0854, 4HL0005, 4HL0036, 4IH0032 that expired by April 2021.

Brand
Spectrum Laboratory Products
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the lot numbers listed in the recall notice to confirm if your product is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

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

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 3.7 years after the firm started it.

Dec 11, 2019Firm started the recall
Dec 23, 2019FDA classified it Class II
Jan 1, 2020Published in FDA’s Enforcement Report
Aug 17, 2023FDA 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/37658-spectrum-estriol-micronized-subpotent-drug-risk">Spectrum Estriol Micronized: Subpotent Drug 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-0628-2020 (December 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0628-2020 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.