FDA News Feed
Latest press releases and announcements directly from the FDA
Recall: Medinatura New Mexico, inc. - ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. ...
Status: Ongoing. Reason: Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Read official releaseRecall: SpecGx, LLC - Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 10...
Status: Ongoing. Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Read official releaseRecall: Imprimis NJOF, LLC - Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0...
Status: Ongoing. Reason: Presence of particulate matter - Glass like particles.
Read official releaseRecall: Medinatura New Mexico, inc. - ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distribut...
Status: Ongoing. Reason: Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Read official releaseRecall: Signature Formulations, LLC - ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per b...
Status: Ongoing. Reason: cGMP Deviations
Read official releaseRecall: AvKARE - Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 1...
Status: Ongoing. Reason: Out of specification for dissolution.
Read official releaseRecall: SpecGx, LLC - Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, ...
Status: Ongoing. Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Read official releaseRecall: Signature Formulations, LLC - ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml),...
Status: Ongoing. Reason: cGMP Deviations
Read official releaseRecall: Alembic Pharmaceuticals Limited - Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Ta...
Status: Ongoing. Reason: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Read official releaseRecall: Imprimis NJOF, LLC - Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, ...
Status: Ongoing. Reason: Presence of particulate matter - Glass like particles.
Read official releaseRecall: Imprimis NJOF, LLC - Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intr...
Status: Ongoing. Reason: Presence of particulate matter - Glass like particles.
Read official releaseRecall: Zydus Pharmaceuticals (USA) Inc - traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, ...
Status: Ongoing. Reason: Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Read official releaseRecall: Glenmark Pharmaceuticals Inc., USA - Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tabl...
Status: Ongoing. Reason: Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Read official releaseRecall: Novo Nordisk Inc. - Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose P...
Status: Ongoing. Reason: Presence of Particulate Matter: Hair was found in a prefilled syringe
Read official releaseRecall: Novo Nordisk Inc. - Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose...
Status: Ongoing. Reason: Presence of Particulate Matter: Hair was found in a prefilled syringe
Read official releaseRecall: CareFusion 213, LLC - BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (C...
Status: Ongoing. Reason: Lack of Assurance of Sterlity
Read official release