--- title: "Denison Pharmaceuticals, LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Denison Pharmaceuticals, LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/denison-pharmaceuticals-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Denison Pharmaceuticals, LLC recall records **7** reported ongoing 8 records in this archive. Latest source date Feb 24, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Feb 24, 2025 FDA drug enforcement ### [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 3740...](https://isitonrecall.com/recall/fda-drug-d-0273-2025-zapzyt-acne-treatment-gel-10-benzoyl-peroxide-gel-packaged-in-1-oz-28-35g-tube-distributed-by-focus/) Chemical Contamination: Presence of benzene. Class II Reported ongoing Distribution: Nationwide within the USA [Official source for Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0273-2025%22) Sep 25, 2024 FDA drug enforcement ### [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., Alant...](https://isitonrecall.com/recall/fda-drug-d-0033-2025-adult-cough-and-chest-congestion-dextromethorphan-hbr-usp-20-mg-guaifenesin-usp-400mg-packaged-in-4/) Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles. Class III Reported ongoing Distribution: Product was distributed to two accounts that may have distributed the product further to the Retail Level. [Official source for Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), package...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0033-2025%22) Sep 25, 2024 FDA drug enforcement ### [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., Ala...](https://isitonrecall.com/recall/fda-drug-d-0034-2025-kids-cough-and-chest-congestion-dextromethorphan-hbr-usp-5mg-guaifenesin-usp-100-mg-packaged-in-4-oz/) Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles. Class III Reported ongoing Distribution: Product was distributed to two accounts that may have distributed the product further to the Retail Level. [Official source for Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packag...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0034-2025%22) May 28, 2024 FDA drug enforcement ### [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](https://isitonrecall.com/recall/fda-drug-d-0557-2024-little-remedies-gas-relief-drops-simethicone-antigas-packaged-in-1-fl-oz-30-ml-bottle-with-dropper-d/) cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error. Class II Reported terminated Distribution: Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals. [Official source for Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0557-2024%22) May 3, 2023 FDA drug enforcement ### [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.](https://isitonrecall.com/recall/fda-drug-d-0772-2023-safe-tussin-dm-day-time-cough-relief-dextromethorphan-hbr-usp-10mg-guaifenesin-usp-100mg-4-0-fl-oz-1/) CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Class II Reported ongoing Distribution: Product was distributed Nationwide. [Official source for Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0772-2023%22) May 3, 2023 FDA drug enforcement ### [Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.](https://isitonrecall.com/recall/fda-drug-d-0773-2023-colic-calm-colic-gas-reflux-homeopathic-medicine-2-fl-oz-59-ml-bottle-distributed-by-ketomi-llc-1215/) CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Class II Reported ongoing Distribution: Product was distributed Nationwide. [Official source for Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ke...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0773-2023%22) May 3, 2023 FDA drug enforcement ### [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. ...](https://isitonrecall.com/recall/fda-drug-d-0774-2023-pin-away-pyrental-pamoate-pyrantel-base-50-mg-ml-pinworm-treatment-2-fl-oz-60-ml-bottle-distributed/) CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Class II Reported ongoing Distribution: Product was distributed Nationwide. [Official source for Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, D...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0774-2023%22) May 3, 2023 FDA drug enforcement ### [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 08...](https://isitonrecall.com/recall/fda-drug-d-0775-2023-safe-tussin-pm-night-time-cough-relief-dextromethorphan-hbr-usp-7-5mg-doxylamine-succinate-3-125mg-4/) CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Class II Reported ongoing Distribution: Product was distributed Nationwide. [Official source for Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0775-2023%22) ## Reasons in these listed records - Chemical Contamination: Presence of benzene. - Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles. - cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error. - CGMP Deviations: Use of non-food grade lubricant in mixing vessel. These examples come from this result page and are not a ranking of every recall reason. ## Checking Denison Pharmaceuticals, LLC ### Is there a recall on denison pharmaceuticals, llc right now? This archive contains 8 records, including 7 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Denison Pharmaceuticals, LLC](https://isitonrecall.com/check/?q=Denison%20Pharmaceuticals%2C%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)