FDA Recalls Estradiol Hemihydrate Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Estradiol Hemihydrate USP for prescription compounding because it lacks stability data to support its expiration date.
What this means for you
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, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a documentation and stability data deficiency rather than a confirmed contamination or acute injury risk.
Plain-English summary
American Pharmaceutical Ingredients LLC is recalling Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding. The product is available in 5g, 25g, and 100g packages and is distributed nationwide within the United States. The specific lot number is 083017-1, with an expiration date of 7/22/2022.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacks the stability data and controls necessary to support the assigned retest or expiration date for the product in its current container/closure system.
This recall affects pharmacies and compounding facilities that may have purchased the product. Consumers who have this product should contact their pharmacist or healthcare provider for guidance on whether to discontinue use or obtain a replacement.
The recalled product
- Product
- Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, packaged in a) 5g (NDC 58597-8001-3); b) 25g (NDC 58597-8001-5); c)100 g (NDC 58597-8001-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Pharmaceutical Ingredient
- Affected units
- 4,910
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 (5)
- Lot: #:a) 083017-1
- Exp. 7/22/2022
- b) 083017-1
- c) 083017-1
- Exp. 7/22/2022.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 66 recalled by American Pharmaceutical Ingredients LLC 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.
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