Class II · Moderate risk Terminated
Rugby Diocto Syrup
Reason Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Rugby Diocto Liquid
Reason Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Class III · Low risk Terminated
Glipizide Extended-Release Tablets
Reason Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
Class I · High risk Terminated
Natural Herbal Coffee Ampt
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil and tadalafil and undeclared milk. The presence of sildenafil and tadalafil makes AMPT Natural Herbal Coffee an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Additionally, this product has been found to contain undeclared milk, milk is recognized as one of the foods reported to have caused deaths due to anaphylactic shock in persons with underlying hypersensitivities.
Class II · Moderate risk Terminated
Famotidine USP 20 mg
Reason Failed Tablet/Capsule Specification: out of specification for tablet weight.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason Presence of Particulate Matter; stainless steel
Class II · Moderate risk Terminated
Hydromorphone Hydrochloride Injection
Reason Presence of Particulate Matter: Silicone oil
Class II · Moderate risk Terminated
Hydromorphone Hydrochloride Injection
Reason Presence of Particulate Matter: Silicone oil
Class II · Moderate risk Terminated
Hydromorphone Hydrochloride Injection
Reason Presence of Particulate Matter: Silicone oil
Class III · Low risk Terminated
Albuterol Sulfate Inhalation Solution
Reason Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
Class II · Moderate risk Terminated
Famotidine Tablets USP
Reason Failed Tablet/Capsule Specification; out of specification for tablet weight
Class I · High risk Terminated
LaBri's Body Health XPLODE 30 capsules Exclusively distribute…
Reason Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
Class I · High risk Terminated
LaBri's Body Health Atomic 60 Capsules Exclusively distributed…
Reason Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
Class I · High risk Terminated
Super Panther 7K Capsules 1250 mg blend
Reason Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil
Class II · Moderate risk Terminated
Entecavir Tablets 0.5 mg
Reason Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Class III · Low risk Terminated
Voriconazole Tablets
Reason Failed impurities/degradation specifications: Out of specification for a related compound C.
Class I · High risk Terminated
New Kopi Jantan Tradisional Natural Herbs Coffee
Reason Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk.
Class III · Low risk Terminated
Make Up Perfect terra
Reason Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk Terminated
Make Up Perfect dark tan
Reason Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk Terminated
Make Up Perfect sand
Reason Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk Terminated
Make Up Perfect pastel
Reason Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk Terminated
Make Up Perfect ivory
Reason Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk Terminated
Make Up Transparent terra
Reason Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk Terminated
Make Up Transparent dark tan
Reason Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.
Class III · Low risk Terminated
Make Up Perfect caramel
Reason Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.