The Recall Desk
ModerateFDA (Drugs)·D-0528-2018·Announced 2018-02-28

FDA Recalls Testosterone USP Micronized for Prescription Compounding

American Pharmaceutical Ingredients LLC is recalling Testosterone USP (Micronized) (Yam) for prescription compounding due to CGMP deviations regarding stability data and expiration date controls.

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 indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The specific hazard is a CGMP deviation regarding stability data, which is a quality control issue rather than a direct contamination or acute injury risk, fitting the Moderate severity criteria for voluntary precautionary or quality-based recalls without reported injuries.

Plain-English summary

American Pharmaceutical Ingredients LLC is recalling Testosterone USP (Micronized) (Yam) for prescription compounding. The product is available in 25g, 100g, 500g, and 1000g packages and is intended for prescription use only. The recall involves a total quantity of 192,000 grams distributed nationwide within the USA.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm lacked stability data and controls to support the assigned retest or expiration dates in its container/closure system. This deficiency raises concerns about the product's stability and safety over its labeled shelf life.

Consumers and healthcare providers should discontinue use of the affected lots and return the product to the point of purchase or contact the recalling firm for instructions. The affected lot numbers and expiration dates are listed in the structured product information provided by the FDA.

The recalled product

Product
Testosterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 25g (NDC 58597-8546-4); b) 100g (NDC 58597-8546-6); c) 500g (NDC 58597-8546-7); d) 1000g (NDC 58597-8546-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford,
Manufacturer
American Pharmaceutical Ingredients LLC
Category
Drug — Pharmaceutical Ingredient
Hazard
Affected units
192,000

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 (16)

  • Lot #: a) b) 032117C-1
  • Exp. 02/11/2020
  • 070716-2
  • Exp. 03/22/2019
  • 121616-1
  • Exp. 08/20/2019
  • 071516-3
  • Exp. 4/1/2019
  • c) 032117C-1
  • 070716-1
  • Exp. 08/20/2019 d) 032117C-1
  • 061317-1
  • Exp. 4/30/2020
  • 061617-1
  • Exp. 05/01/2020
  • Exp. 8/20/2019.

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 →

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