Enovachem Recalls Estriol USP Micronized 0.24 g Due to Impurity Failures
Enovachem Pharmaceuticals is recalling Estriol USP (Micronized) 0.24 g because additional testing revealed out-of-specification impurity results.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a quality control failure (impurities) without reported adverse health consequences, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Asclemed USA Inc. dba Enovachem Pharmaceuticals is recalling Estriol, USP, (Micronized), 0.24 g. The recall was initiated after additional testing identified out-of-specification impurity test results for the product.
The affected product is distributed by Enovachem Pharmaceuticals in Torrance, California, and carries NDC #76420-049-38. The source text does not specify the total quantity of product recalled, but the structured data indicates a product quantity of 56.4 gm. The product was distributed to six physician's offices within the state of California.
Patients who have received this medication should contact their healthcare provider for guidance on next steps. The source text does not provide specific instructions for consumers beyond the standard recall notification.
The recalled product
- Product
- Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38
- Manufacturer
- Asclemed USA Inc. dba Enovachem Pharmaceuticals
- Category
- Drug — Pharmaceutical
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by Asclemed USA Inc. dba Enovachem Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Asclemed USA Inc. dba Enovachem Pharmaceuticals
See all →- LowEnovachem Recalls Methylprednisolone Tablets Due to Illegible Labeling
FDA (Drugs) · 2021-04-21
- SevereEnovachem Recalls Estriol USP 0.06 g Due to Impurity Failures
FDA (Drugs) · 2020-01-15
- ModerateEnovachem Recalls Estriol USP Micronized Due to Impurity Test Failures
FDA (Drugs) · 2020-01-15
Same hazard · impurity
See all →- ModerateAjanta Pharma Recalls Fluphenazine Hydrochloride Tablets Due to Impurity Failure
FDA (Drugs) · 2026-09-16
- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
Similar recalls
- SevereMedisca Recalls Estriol USP Micronized Due to Failed Impurity Specifications
FDA (Drugs) · 2019-12-25
- ModerateTriova Recalls Estriol USP Micronized 5 G Due to Impurities
FDA (Drugs) · 2020-06-10
- ModerateMedisca Recalls Estriol USP Bulk Due to cGMP Deviations
FDA (Drugs) · 2017-04-19
- ModerateSpectrum Laboratory Products Recalls Subpotent Estriol Micronized USP
FDA (Drugs) · 2020-01-01
- ModerateDrug Recall: Estriol USP41 Micro Due to cGMP Deviations
FDA (Drugs) · 2021-08-04
- ModerateFDA Recalls Estriol Micronized Bulk Drug Due to Quality Assurance Failures
FDA (Drugs) · 2017-04-19