The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0526-2018·Announced 2018-02-28

FDA Recalls Testosterone Cypionate Due to Missing Stability Data

American Pharmaceutical Ingredients LLC is recalling Testosterone Cypionate 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 typically associated with a temporary or medically reversible adverse health consequence. The hazard is a lack of stability data, which is a quality control issue rather than a direct contamination or acute safety defect, fitting the 'Moderate' criteria for minor labeling or quality errors without reported illness.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Testosterone Cypionate USP (Micronized) for prescription compounding. The product is packaged in 100g, 500g, and 1000g containers and is packed by American Pharmaceutical Ingredients, LLC. The recall covers specific lots with expiration dates of 01/21/2019 and 10/17/2018, distributed nationwide within the USA.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacks the necessary stability data and controls to support the assigned retest or expiration dates for the product in its container/closure system. This deficiency means the product's stability over time has not been adequately verified.

This recall affects pharmacies and compounding facilities that may have purchased or received these specific lots of Testosterone Cypionate USP. Consumers who have been prescribed or dispensed this medication should consult their healthcare provider or pharmacist for guidance on whether to stop using the product and how to obtain a replacement.

The recalled product

Product
Testosterone Cypionate USP (Micronized) for prescription compounding, packaged in a)100g (NDC 58597-0078-6); b) 500g (NDC 58597-0078-7); c) 1000g (NDC 58597-0078-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Manufacturer
American Pharmaceutical Ingredients LLC
Category
Drug — Pharmaceutical Ingredient
Hazard
Affected units
611,400

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 (14)

  • Lot #: a) 032117A-6
  • Exp. 01/21/2019
  • 112916-2
  • 112916-4
  • Exp. 10/17/2018
  • b) 032117A-4
  • 032117A-5
  • 112916-1
  • c) 032117A-1
  • 032117A-2
  • 032117A-3
  • 032117A-4
  • 112916-3
  • Exp. 10/17/2018.

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 →

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