The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0518-2018·Announced 2018-02-28

Progesterone USP Recalled for Lack of Stability Data and Controls

American Pharmaceutical Ingredients LLC is recalling Progesterone USP for prescription compounding due to CGMP deviations involving missing stability data and controls.

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 typically indicates a situation where use of the product could cause temporary or medically reversible 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 low-risk contamination or voluntary precautionary recalls.

Plain-English summary

American Pharmaceutical Ingredients LLC is recalling specific lots of Progesterone USP (Micronized) (Yam) for prescription compounding. The product is available in various package sizes, including 1g, 10g, 25g, 100g, 500g, 1000g, and 5000g, and is distributed nationwide within the USA. The total quantity involved is 1,050,000 g.

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 quality and safety over time.

Healthcare providers and pharmacies should stop using the affected lots and contact the recalling firm for instructions on return or disposal. Patients who have received prescriptions containing these specific lots should consult their healthcare provider for guidance.

The recalled product

Product
Progesterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8471-1); b) 10g (NDC 58597-8471-3); c) 25g (NDC 58597-8471-4); d) 100g (NDC 58597-8471-6); e) 500g (NDC 58597-8471-7); f) 1000g (NDC 58597-8471-8); g) 5000g (NDC 58597-8471-9), RX…
Manufacturer
American Pharmaceutical Ingredients LLC
Category
Drug — Pharmaceutical Ingredient
Hazard
Affected units
1,050,000

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 (20)

  • Lot #: a) 031115-3
  • Exp. 12/24/2019
  • b) 031115-3
  • Exp. 12/24/2019 c) 031115-3
  • 050815-3
  • Exp. 04/14/2020
  • d) 010716-1
  • 010716-6
  • Exp. 11/10/2018
  • 030116-4
  • Exp. 12/04/2018
  • 031115-2
  • 060116-9
  • Exp. 4/28/2019
  • 080416-1
  • 080416-4
  • Exp. 06/05/2019
  • 080615-4
  • Exp. 07/29/2020
  • 112015-6

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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