Denison Pharmaceuticals recalls

4 official recalls and safety alerts involving Denison Pharmaceuticals since 2023-06, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Denison Pharmaceuticals or the relevant agency.

  1. 2025-03-19
  2. US
    Drugs & medicalClass II

    Denison Pharmaceuticals, LLC recalls Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE,…

    Chemical Contamination: Presence of benzene.

    FDA · DrugDenison Pharmaceuticals, LLCNationwide within the USAOfficial notice →
  3. 2024-11-13
  4. US
    Drugs & medicalClass III

    Denison Pharmaceuticals, LLC recalls Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package…

    Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

    FDA · DrugDenison Pharmaceuticals, LLCProduct was distributed to two accounts that may have distributed the product…Official notice →
  5. 2024-06-26
  6. US
    Drugs & medicalClass II

    Denison Pharmaceuticals, LLC recalls Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products…

    cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.

    FDA · DrugDenison Pharmaceuticals, LLCRecalled units were distributed to one customer. 100% recovered (113,544…Official notice →
  7. 2023-06-07
  8. US
    Drugs & medicalClass II

    Denison Pharmaceuticals, LLC recalls Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Incorporated,…

    CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

    FDA · DrugDenison Pharmaceuticals, LLCProduct was distributed Nationwide.Official notice →