All recalls7,877 total
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Undeclared milk
Undeclared milk
Undeclared milk
Undeclared Milk. During an FDA investigation the manufacturer was notified that the label does not list the allergen milk in the ingredient statement.
Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Product may have Listeria Monocytogenes.
Product may have Listeria Monocytogenes.
Presence of cathine in product
LABELING: LABEL MIX-UP
LABELING: LABEL MIX-UP
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Potential contamination of undeclared allergen peanuts
Ingredient (mustard seeds) tested positive for Salmonella
Failed Dissolution Specifications:
Undeclared allergens (Wheat and Soy)
Failed Impurities/Degradation Specifications
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
Product may contain spoilage organisms.
Potential for premature product spoilage during shelf life.
Presence of Foreign Tablets/Capsules
Product contains undeclared FD&C Yellow 5 and FD&C Yellow 6.
Possible Salmonella contamination of affected product.
Cucumbers may be contaminated with Salmonella.
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Potential for packaging failures that could compromise the sterility of the product, resulting in spoilage.
Products may contain foreign objects (plastic).
Foreign material (plastic)
Due to the presence of Toxic yellow oleander
Products may contain foreign objects (plastic).