Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0527-2018·Announced 2018-02-28

FDA Recalls Testosterone Enanthate USP Due to Missing Stability Data

American Pharmaceutical Ingredients LLC is recalling Testosterone Enanthate USP for prescription compounding because the manufacturer lacks stability data to support the assigned 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, which is a moderate risk. The hazard is a documentation and validation issue (lack of stability data) rather than a direct contamination or acute safety defect, and no illnesses or injuries are reported in the source text.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Testosterone Enanthate USP for prescription compounding, manufactured by American Pharmaceutical Ingredients LLC. The product is available in 25g, 100g, 500g, and 1000g packages and is distributed nationwide within the United States.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacks the necessary stability data and controls to support the retest or expiration dates assigned to the product in its container/closure system. This means the assigned expiration dates may not be scientifically validated.

Healthcare professionals and patients who have this product should stop using it and contact their healthcare provider or the manufacturer for further instructions. The recall covers specific lots with expiration dates ranging from January 2019 to April 2019.

The recalled product

Product: Testosterone Enanthate USP for prescription compounding, packaged in a) 25g (NDC 58597-0079-4); b) 100g (NDC 58597-0079-6); c) 500g (NDC 58597-0079-7); d) 1000g (NDC 58597-0079-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI…
Manufacturer: American Pharmaceutical Ingredients LLC
Category: Drug — Prescription Compounding Ingredient
Hazard: mis-labeling
documentation-error
Affected units: 47,500

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 (13)

Lot #: a) 042016-2
Exp. 4/6/2019
b) 041217-1
Exp. 02/09/2019
042016-2
042016-3
c) 041217-1
041217-3
042016-1
Exp. 04/06/2019
d) 041217-3
Exp. 01/09/2019
Exp. 4/6/2019.

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.

See all 66 products in this recall →

Same manufacturer · American Pharmaceutical Ingredients LLC

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Same hazard · mis labeling