Class II · Moderate risk
Valsartan 80 mg tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
FDA Drug Recalls
198 recalls, newest first
Class II · Moderate risk
Valsartan tablets 160 mg
Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan HCTZ
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Unit Dose Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Unit Dose Valsartan Tablets
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan/HCTZ 320mg/12.5 mg tablet
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Valsartan/HCTZ 160 mg/12.5 mg tablet
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class I · High risk
XCEL ADVANCED Capsules
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Class I · High risk
XCEL Capsules
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared fluoxetine, an FDA approved drug used to treat depression, anxiety, panic attacks, obsessive-compulsive disorder, or bulimia and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Class I · High risk
Prime Capsules
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Class I · High risk
Oasis Capsules
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Class I · High risk
La' Trim Plus Capsules
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Class I · High risk
Jenesis Capsules
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Class I · High risk
EVOLVE BEE POLLEN Capsules
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Class I · High risk
Asset BOLD Capsules
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.