The Recall Desk
ModerateFDA (Drugs)·D-0519-2018·Announced 2018-02-28

Sildenafil Citrate USP Recalled Due to Missing Stability Data

American Pharmaceutical Ingredients LLC is recalling Sildenafil Citrate USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.

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 the product may cause temporary or medically reversible health consequences. The specific issue is a lack of stability data to support expiration dates, which is a quality control deviation rather than a direct contamination or mislabeling of an allergen or pathogen.

Plain-English summary

American Pharmaceutical Ingredients LLC is recalling Sildenafil Citrate USP for prescription compounding. The product is available in 5g, 25g, 50g, 100g, 500g, and 1000g packages and is distributed nationwide within the USA. The recall involves a total of 307,500 grams of the product.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacked stability data and controls to support the assigned retest or expiration dates in the firm's container/closure system. This means the expiration dates printed on the product may not be scientifically validated.

The affected lots include various lot numbers with expiration dates ranging from March 31, 2020, to December 31, 2021. Consumers and pharmacies should stop using the affected product and contact the manufacturer or their pharmacist for further instructions.

The recalled product

Product
Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 58597-8088-2);b) 25g (NDC 58597-8088-4); c) 50g (NDC 58597-8088-5); d) 100g (NDC 58597-8088-6); e) 500g (NDC 58597-8088-7); f)1000g (NDC 58597-8088-8), RX only, packed by American Pharmaceutical Ingredien
Manufacturer
American Pharmaceutical Ingredients LLC
Category
Drug — Pharmaceutical Ingredient
Hazard
Affected units
307,500

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 (20)

  • Lot #: a) 021317-4
  • Exp. 12/31/2021
  • b) 021317-2R
  • 021317-4
  • 050115-4
  • Exp. 3/31/2020
  • 101915-5
  • Exp. 08/31/2020 c) 050115-3
  • Exp. 03/31/2020
  • d) 021317-3R
  • Exp 12/31/2021
  • 050115-2
  • 050115-3
  • 101915-3
  • 101915-4
  • Exp. 08/31/2020
  • e) 021317-2R
  • exp. 03/31/2020
  • 101915-1
  • 101915-2

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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