The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0026-2015·Announced 2014-10-22

Valeant Recalls Subpotent Locoid Hydrocortisone Butyrate Cream Tubes

Valeant Pharmaceuticals is recalling 1,663 tubes of Locoid cream because the active ingredient and preservatives were subpotent at the 18-month stability test point.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 III, which typically corresponds to a low risk of adverse health consequences. The hazard is subpotency, which is a quality issue rather than a direct safety hazard like contamination or mislabeling of a common allergen.

Plain-English summary

Valeant Pharmaceuticals International is recalling 1,663 tubes of Locoid (hydrocortisone butyrate 0.1%) cream, 15 gm tubes. The product is prescription-only and was manufactured for Onset Dermatologics, LLC by Ferndale Laboratories, Inc. The specific lot number is 13052B, with an expiration date of 03/2015 and NDC 16781-382-15.

The recall was initiated because the active ingredient (hydrocortisone butyrate) and the preservatives propylparaben and butylparaben were found to be subpotent at the 18-month stability test point. Subpotent levels mean the product may not contain the full amount of the active ingredient or preservatives required to ensure efficacy and safety.

The affected product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should discontinue use of the recalled product and contact their healthcare provider for guidance on alternative treatments. The recall is classified as Class III by the FDA, indicating a low risk of adverse health consequences.

The recalled product

Product
Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, Manufactured for: Onset Dermatologics, LLC, Cumberland, RI 02864 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 16781-382-15
Manufacturer
Valeant Pharmaceuticals International
Category
Drug — Topical Steroid
Hazard
Affected units
1,663

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 (3)

  • Lot number 13052B
  • Exp. 03/2015
  • NDC16781-382-15

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Valeant Pharmaceuticals International 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 2 products in this recall →

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