The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0495-2018·Announced 2018-02-28

FDA Recalls Hydroxyprogesterone Caproate Due to Missing Stability Data

American Pharmaceutical Ingredients LLC is recalling Hydroxyprogesterone Caproate USP for prescription compounding because the manufacturer lacked 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 the rubric associates with moderate severity, particularly when the issue is a manufacturing deviation (lack of stability data) rather than a confirmed high-risk pathogen or immediate physical hazard.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Hydroxyprogesterone Caproate USP intended for prescription compounding. The product is packaged in 25g, 100g, and 500g containers and is packed by American Pharmaceutical Ingredients, LLC. The recall covers specific lots with expiration dates of July 23, 2018, and October 5, 2019.

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 retest or expiration dates assigned to the product in its container/closure system. This means the assigned expiration dates may not accurately reflect the product's stability over time.

The affected product was distributed nationwide within the United States. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be returned to the supplier or disposed of according to local regulations. Patients should consult their healthcare provider regarding alternative treatments if they have been prescribed this specific ingredient.

The recalled product

Product
Hydroxyprogesterone Caproate USP for prescription compounding, packaged in a) 25g (NDC 58597-8051-4); b) 100g (NDC 58597-8051-6); c) 500g (NDC 58597-8051-7), 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
26,500

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 (7)

  • Lot #: a) 081015-1
  • Exp 07/23/2018
  • b) 081015-1
  • 111116-1
  • Exp. 10/05/2019
  • c) 081015-1
  • Exp. 07/23/2018

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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