Asclemed USA Inc. dba Enovachem Pharmaceuticals recalls Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36
Enovachem Pharmaceuticals recalls Estriol tablets with impurity test results out of specification. Consumers should check lot codes and contact the company for details.
Recall notice
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Contact the company & request your remedy
What happened, in plain English
Enovachem Pharmaceuticals is recalling Estriol tablets that failed impurity testing. This could pose a risk of harmful substances in the medication. Read more at govinfonow.com/recall/37660-enovachem-estriol-micronized-tablets-recall-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37660-enovachem-estriol-micronized-tablets-recall-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0650-2020
Cite this page
“Enovachem Estriol Micronized Tablets Recall: Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37660-enovachem-estriol-micronized-tablets-recall-impurity-risk. Based on FDA recall #D-0650-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0650-2020%22&limit=1).
Why it’s dangerous
The tablets contain impurities that did not meet safety standards. This could lead to harmful substances entering the body through medication use.
Who’s affected
Women using Estriol tablets for hormone replacement therapy may be affected. Those with specific lot codes listed in the recall are most at risk.
How to tell if you have this one
Check the lot code on the packaging. The affected lots include 11061901, 04011903, 04221904, 04241904, 06031902, 07301905, 09061903 with expiration dates up to 12/31/2020.
- Brand
Enovachem Pharmaceuticals- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Product was distributed to 6 physician's offices within the state of California.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0650-2020 | Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36; Lot Code/Exp. Date: 11061901, 04011903, 04221904, 04241904, 06031902, 07301905, 09061903, EXP 12/31/2020 | 8.52 gm |
| D-0651-2020 | Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37; Lot Code/Exp. Date: 11061901, 11061803, 11281804, 11291804, 04171902, 05201901, 08121902, EXP 12/31/2020; 08161901, 10111903, EXP 5/31/2021; 11211904, 10161901, EXP 8/31/2021 | 42.12 gm |
| D-0652-2020 | Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38; Lot Code/Exp. Date: 11191804, 12281802, 01211902, 01281901, 02071903, 02221902, 03111903, 03251902, 04011905, 04091903, 04221907, 05211902, 06071902, 06241903, 07111903, 07301902, 08271902, 09061904, 09161902, EXP 12/31/2020; 09161901, 10091905, 10221902, 10311901, EXP 5/31/2021; 11211902, 10311902, EXP 8/31/2021 | 56.4 gm |
What to do — step by step
Check Lot Code
Look for the lot code on the packaging to determine if it is affected.
Questions people ask
What is the product being recalled?
Estriol, USP, (Micronized), 0.06 g tablets distributed by Enovachem Pharmaceuticals.
What lot codes are affected?
Affected lot codes include 11061901, 04011903, 04221904, 04241904, 06031902, 07301905, 09061903 with expiration dates up to 12/31/2020.
What should I do if I have the recalled product?
The recall record does not specify a remedy, so contact Enovachem Pharmaceuticals for further instructions.
Contact Enovachem Pharmaceuticals
We’ve drafted a message you can send Enovachem Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0650-2020 — Enovachem Pharmaceuticals Enovachem Pharmaceuticals Hello, I own a Enovachem Pharmaceuticals that is covered by recall D-0650-2020 from Enovachem Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0650-2020 (December 9, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0650-2020 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.