1,739 recalls · Class I, newest first
Reason Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 bottle labeled as Rugby label Enteric Coated Aspirin…
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibutramine and phenolphthalein, two active ingredients…
Reason Non-Sterility: The firm's contract testing laboratory found sterility failures.
Reason The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free…
Reason The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free…
Reason Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.
Reason Presence of Particulate Matter: Found during examination of retention samples.
Reason Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety…
Reason Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety…
Reason Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were…
Reason Non-Sterility; contract laboratory identified Staphylococcus warneri in the product
Reason Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Reason Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of…
Reason Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of…
Reason Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat…
Reason Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat…
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and…
Reason Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and…
Reason Non-Sterility
Reason Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control…
Reason Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control…
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain sulfoaildenafil, an analogue of sildenafil which is an ingredient in…
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain hydroxythiohomosildenafil, an analogue of sildenafil which is an…
Reason Presence of Particulate Matter: reports of small grey/brown particles found in the primary container identified as brass particulates
Reason Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.