The Recall Desk
ModerateFDA (Drugs)·D-0086-2021·Announced 2020-11-25

Milbar Recalls DCL SA Scalp Therapy Shampoo Due to GMP Deviations

Milbar Laboratories is recalling 1,815 bottles of DCL SA Scalp Therapy Shampoo due to Good Manufacturing Practice (GMP) deviations.

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 due to GMP deviations, which falls under the 'voluntary precautionary recalls' or 'low-risk contamination' criteria for a Moderate severity score, as no specific injuries or illnesses are reported in the source text.

Plain-English summary

Milbar Laboratories, Inc. is voluntarily recalling 1,815 bottles of DCL SA Scalp Therapy Shampoo (Salicylic Acid 3%), 300 ml/10.1 fl.oz. The recall was initiated on October 9, 2020, and was classified as Class II by the FDA. The reason for the recall is Good Manufacturing Practice (GMP) deviations.

The affected product is identified by Lot # KV092-3 (Expiration Date Nov-21) and Lot # FX456-7 (Expiration Date Jun-23). The product was distributed throughout the United States, including Puerto Rico, and internationally. The recall was terminated on January 4, 2023.

Consumers who have this product should stop using it and contact Milbar Laboratories for further instructions or a refund. The recall was initiated by the firm and notified via letter.

The recalled product

Product
DCL SA Scalp Therapy Shampoo (Salicylic Acid 3%) 300 ml/10.1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 357486503120
Manufacturer
Milbar Laboratories, Inc.
Category
Drug — Topical Dermatologic
Hazard
Affected units
1,815

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 #: KV092-3
  • Exp. Date Nov-21 Lot #: FX456-7
  • Exp. Date Jun-23

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 14 recalled by Milbar Laboratories, Inc. 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 14 products in this recall →

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