Class II · Moderate risk Ongoing
PReye Vitamin See Antioxidant Preservative Free Eye Drops
Reason Lack of Assurance of Sterility
Is Gold recalled?
Yes — there is an active recall. 12 ongoing FDA recalls mention Gold (45 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Gold. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Class II · Moderate risk Ongoing
Deodorant: a) Axe
Reason CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk Ongoing
Trinity Gold Nutrition
Reason Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
Class I · High risk Ongoing
Gold Hard Steel Plus Liquid
Reason Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Class II · Moderate risk Ongoing
Natural Pain Relieving Cream
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk Ongoing
Natural Pain Relieving Cream
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk Ongoing
Natural Pain Relieving Cream
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk Ongoing
Natural Pain Relieving Cream
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk Terminated
Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Naproxen Sodium Tablets
Reason CGMP Deviations
Class II · Moderate risk Terminated
Naproxen Sodium Tablets
Reason CGMP Deviations
Class I · High risk Terminated
PremierZEN Gold 7000 capsule
Reason Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class II · Moderate risk Ongoing
Imperial Gold 2000
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class II · Moderate risk Ongoing
Triple SupremeZen Gold 3500
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Class I · High risk Terminated
Goldenseal POWDER
Reason Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Class I · High risk Terminated
Goldenseal Root Powder Organic
Reason Microbial Contamination of Non-Sterile Products: FDA laboratory analysis found product to be contaminated with various microorganisms including Enterobacter cloacae, Cronobacter sakazakii, Cronobacter dublinensis, among others.
Class III · Low risk Terminated
Clobetasol Propionate Cream
Reason Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Class III · Low risk Terminated
Clobetasol Propionate Cream USP
Reason Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Class II · Moderate risk Terminated
Purple Gold Balm
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk Terminated
Purple Gold Balm
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class I · High risk Terminated
Silver Bullet
Reason Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.
Class I · High risk Terminated
Blissful Remedies Gold Series Ultra Enhanced Indo
Reason Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Class I · High risk Terminated
Gaia Kratom
Reason Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class II · Moderate risk Terminated
Alka-Seltzer Gold
Reason Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
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