Yes — there is an active recall. 47 ongoing FDA recalls mention Zinc (156 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Zinc. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Unapproved new drug
Lack of sterility assurance.
Lack of sterility assurance.
Lack of sterility assurance.
Lack of Assurance of Sterility
Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
Microbial Contamination of Non-Sterile Products: sample tested positive for Staphylococcus aureus.
Incorrect Product Formulation: wrong sunscreen product in the package.
Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
Subpotent
GMP Deviations
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