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. Source coverage and dates.

Records and reported status

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...

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

Class IIIReported 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...
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...

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

Class IIIReported 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...
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

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

Class IIReported 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...

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 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 and the agency's current notices.

Where can I find older records?

Use monthly 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.

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