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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Topical Products

Allergan PLC: Skin Medica Acne Treatment Lotion and Kits Recalled for Low Potency

Agency Publication Date: July 27, 2020
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Summary

Allergan PLC is recalling approximately 12,573 units of Skin Medica Acne Treatment Lotion and Acne Systems because the products are subpotent, meaning they failed testing for active ingredient levels at the 12 and 24-month marks. This recall includes 4,018 individual 2 oz bottles of the Benzoyl Peroxide 2.5% lotion and 8,555 Acne System kits containing various salicylic acid and benzoyl peroxide treatments. These products were distributed nationwide across the United States. If you have these products, you should contact your healthcare provider or pharmacist for guidance regarding their effectiveness.

Risk

The drug products failed assay results, meaning they do not contain the expected amount of active ingredients required to effectively treat acne. Using a subpotent medication may result in the failure of the treatment to manage the skin condition as intended.

What You Should Do

  1. Check your individual 2 oz bottle of Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%) for NDC 0023-4965-02 and any of the following lot numbers: 087293 (Exp. 06/30/2020), 091356 (Exp. 03/31/2021), 093770 (Exp. 07/31/2021), or 093771 (Exp. 07/31/2021).
  2. Check your Skin Medica Acne System kit for UPC 300234966005 and any of the following lot numbers: 090645A, 090645B (Exp. 07/31/2020); 090645C (Exp. 08/31/2020); 090757A (Exp. 02/29/2020); 093199A, 093199B, 093199C, 093199D (Exp. 12/31/2020); 096375A, 096375B (Exp. 06/30/2021); 097455A (Exp. 04/30/2021); or 097612A (Exp. 04/30/2021).
  3. Contact your healthcare provider or pharmacist for guidance if you have used these subpotent products and have concerns about your treatment.
  4. Return any unused or expired product to the place of purchase for a refund and contact Allergan PLC at their Irvine, CA office for further instructions.
  5. Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or wish to report an issue.

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug potency issue remedy

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%) (2 Oz bottle)
Model:
NDC 0023-4965-02
Lot Numbers:
087293 (Exp. 06/30/2020)
091356 (Exp. 03/31/2021)
093770 (Exp. 07/31/2021)
093771 (Exp. 07/31/2021)
Date Ranges: Exp. Date 06/30/2020, Exp. Date 03/31/2021, Exp. Date 07/31/2021
Product: Skin Medica Acne System (Kits)
UPC Codes:
300234966005
Lot Numbers:
090645A (Exp. 07/31/2020)
090645B (Exp. 07/31/2020)
090645C (Exp. 08/31/2020)
090757A (Exp. 02/29/2020)
093199A (Exp. 12/31/2020)
093199B (Exp. 12/31/2020)
093199C (Exp. 12/31/2020)
093199D (Exp. 12/31/2020)
096375A (Exp. 06/30/2021)
096375B (Exp. 06/30/2021)
097455A (Exp. 04/30/2021)
097612A (Exp. 04/30/2021)
Date Ranges: Exp. Date 07/31/2020, Exp. Date 08/31/2020, Exp. Date 02/29/2020, Exp. Date 12/31/2020, Exp. Date 06/30/2021, Exp. Date 04/30/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85924
Status: Resolved
Manufacturer: Allergan PLC
Manufactured In: United States
Units Affected: 2 products (4,018 bottles; 8,555 kits)
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.