Severe Congestion Nasal Spray
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Yes — there is an active recall. 51 ongoing FDA recalls mention Menthol (132 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Menthol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found within the Red Cross Oral Pain blister pack. The cotton pellet box states that the product contains "Natural Eugenol Oil" in which it does not.
CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.
Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
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