FDA Recalls Testosterone for Compounding Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling Testosterone (Soy) (Micronized) USP for prescription compounding due to a lack of stability data and controls supporting expiration dates.
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 due to CGMP deviations regarding stability data. Per the rubric, this falls under 'voluntary precautionary recalls' or minor labeling/quality errors where no specific illness or injury is reported, aligning with a Moderate severity score.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Testosterone (Soy) (Micronized) USP for prescription compounding, manufactured by American Pharmaceutical Ingredients LLC. The affected product is available in 25g, 100g, 500g, and 1000g packages and is distributed nationwide within the United States. The recall involves specific lot numbers with expiration dates ranging from April 2019 to February 2020.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacked the necessary stability data and controls to support the assigned retest or expiration dates for the product in its container/closure system. This deficiency raises concerns about the product's stability and quality over time.
Healthcare providers and pharmacies should stop using the affected lots immediately. Patients who have received this product should consult their healthcare provider for guidance on whether to discontinue use or obtain a replacement. The FDA classifies this recall as Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Testosterone (Soy) (Micronized) USP for prescription compounding, packaged in a) 25g (NDC 58597-0077-4); b) 100g (NDC 58597-0077-6), c) 500g (NDC 58597-0077-7); d)1000g (NDC 58597-0077-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford…
- Manufacturer
- American Pharmaceutical Ingredients LLC
- Category
- Drug — Pharmaceutical Ingredient
- Affected units
- 33,000
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 (10)
- Lot #: a) 071516-3
- Exp. 04/01/2019
- b) 071516-3
- Exp. 4/1/2019
- c) 071516-1
- 071516-2
- d) 071516-1
- 071516-3
- 032117B-1
- Exp. 2/9/2020.
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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