CLASS II Drug recall · Reported 15 Jan 2020 · FDA Enforcement Report

Estriol, USP, (Micronized) recalled by Asclemed USA

Asclemed USA is recalling Estriol, USP, (Micronized), distributed in California. The recall was initiated on 9 Dec 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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

Quantity recalled56.4 gm

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0652-2020
FDA event ID: 84550
Recalling firm: Asclemed USA, Torrance, CA
Classification: Class II
Status: Terminated
Recall initiated: 9 Dec 2019
FDA classified: 8 Jan 2020
Reported: 15 Jan 2020
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Potency & Assay

Timeline

9 Dec 2019	Recall initiated by company
8 Jan 2020	Classified by FDA	+30 days
15 Jan 2020	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38

Where it was distributed

Product was distributed to 6 physician's offices within the state of California.

California

Questions about this recall

Why was it recalled?

Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.

Which lots are affected?

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

Where was it sold?

Product was distributed to 6 physician's offices within the state of California.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 84550

This product is part of a recall event; the main page for the event is Estriol, USP, (Micronized) recalled by Asclemed USA.

Reported	Class	Recall	Company	Reason	Where
15 Jan 2020	CLASS II	Estriol, USP, (Micronized) recalled by Asclemed USA	Asclemed USA	Potency & Assay	CA
15 Jan 2020	CLASS II	Estriol, USP, (Micronized) recalled by Asclemed USA	Asclemed USA	Potency & Assay	CA

More recalls from Asclemed USA

All 10

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Drug	CLASS III	Lidolog Kit, Kit Contains: Lidocaine HCl Injection recalledLidolog Kit	Asclemed USA	Other	TN
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8 Jul 2026Drug	CLASS II	Accucaine, Kit contains: Lidocaine HCl Injection recalledAccucaine	Asclemed USA	Sterility	Nationwide
10 Jun 2026Drug	CLASS II	Duloxetine DR Capsules, 30 mg, Rx, Relabeled recalled by Asclemed USADuloxetine	Asclemed USA	Nitrosamine Impurity	Nationwide
21 Apr 2021Drug	CLASS III	Asclemed USA products recalled	Asclemed USA	Other	AL, CA, LA

Other Estriol recalls

All 13

Reported	Class	Recall	Company	Reason	Where
13 Jul 2022Drug	CLASS II	Estriol 1mg/gm, Vaginal Cream, 30 gm tube, Qty recalled	Wedgewood Village Pharmacy	Processing Deviation	Nationwide
13 Jul 2022Drug	CLASS II	Estriol 1mg/gm, Vaginal Cream, 60 gm tube, Qty recalled	Wedgewood Village Pharmacy	Processing Deviation	Nationwide
22 Apr 2020Drug	CLASS II	Estriol/Testosterone Vaginal 0.1/0.1% Cream 30 gm, Rx recalled	The Medicine Shoppe Pharmacy	Other	FL
15 Jan 2020Drug	CLASS II	Estriol, USP, (Micronized) recalled by Asclemed USA	Asclemed USA	Potency & Assay	CA
15 Jan 2020Drug	CLASS II	Estriol, USP, (Micronized) recalled by Asclemed USA	Asclemed USA	Potency & Assay	CA