Medisca Recalls Estriol USP Micronized Due to Failed Impurity Specifications
Medisca, Inc. is recalling specific lots of Estriol, USP (Micronized) because the product failed impurities and degradation specifications.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the failure of impurity and degradation specifications for a pharmaceutical product.
Plain-English summary
Medisca, Inc. is recalling specific lots of Estriol, USP (Micronized) in various container sizes (1 g, 5 g, 25 g, 100 g, 2000 g, and 1 kg). The recall is being conducted because the product failed impurities and degradation specifications. The affected lots are #156110 A-P, #153328 A-D, and #161726 A-L.
The recall covers a total of 640,325 grams of the product, which was distributed nationwide. The product was packed by Medisca, Inc. in Plattsburgh, NY.
Consumers and healthcare providers should check their inventory for the specific lot numbers listed above. If you have these products, you should stop using them and contact Medisca, Inc. or your supplier for instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Packed by Medisca Inc., Plattsburgh, NY 12901, USA
- Manufacturer
- Medisca, Inc.
- Category
- Drug — Pharmaceutical Ingredient
- 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 (1)
- Lot #156110 A-P Lot #153328 A-D Lot #161726 A-L
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Medisca, Inc.
See all →- ModerateBimatoprost Bulk Powder Recalled by Medisca for CGMP Deviations
FDA (Drugs) · 2025-04-30
- HighBudesonide USP drug ingredient recalled for glass contamination
FDA (Drugs) · 2024-07-10
- ModerateMedisca Recalls Aminocaproic Acid API Due to CGMP Labeling Deviations
FDA (Drugs) · 2017-09-27
- ModerateMedisca Recalls Estradiol API Due to cGMP Deviations
FDA (Drugs) · 2017-04-19
- ModerateMedisca Recalls Estriol USP Bulk Due to cGMP Deviations
FDA (Drugs) · 2017-04-19
Same hazard · impurities
See all →- ModerateCipla Recalls Fosfomycin Tromethamine Due to Impurity Specification Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Specifications
FDA (Drugs) · 2026-10-14
- LowMacleods Recalls Olanzapine Tablets Due to Impurity Levels
FDA (Drugs) · 2026-09-30
Similar recalls
- ModerateMedisca Recalls Estriol USP Bulk Due to cGMP Deviations
FDA (Drugs) · 2017-04-19
- ModerateEnovachem Recalls Estriol USP Micronized 0.24 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
- SevereMedisca Recalls Estrone USP Bulk Due to cGMP Deviations
FDA (Drugs) · 2017-04-19
- SevereEnovachem Recalls Estriol USP 0.06 g Due to Impurity Failures
FDA (Drugs) · 2020-01-15
- ModerateMedisca Recalls Estradiol Bulk Due to cGMP Deviations
FDA (Drugs) · 2017-04-19