Lincoln, RI, United States
Denison Pharmaceuticals, LLC recalls
4 recalls recorded since 2018, most recently on 24 February 2025. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)3
Terminated or completed1
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 24 February 2025
- Reason
- Chemical Contamination: Presence of benzene.
- Distribution
- Nationwide within the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0273-2025
- Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 801 Broad St Ste 200, Chattanooga, TN 37402. NDC 71687-0011-1
Ongoing Class III Drugs
- Recall started
- 25 September 2024
- Reason
- Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
- Distribution
- Product was distributed to two accounts that may have distributed the product further to the Retail Level.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0033-2025, D-0034-2025
- Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code
- Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code#
Terminated Class II Drugs
- Recall started
- 28 May 2024
- Terminated
- 26 August 2025
- Reason
- cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
- Distribution
- Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0557-2024
- Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc., Tarrytown, NY 10591, NDC 63029-103-02
Ongoing Class II Drugs
- Recall started
- 3 May 2023
- Reason
- CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
- Distribution
- Product was distributed Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0774-2023, D-0775-2023, D-0773-2023, D-0772-2023
- Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Incorporated, 333 Strawberry Field Road, Warwick, RI 05886. NDC 70309-080-02
- Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
- Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.
- Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.