Medicamentos y Fármacos Recalls
Pharmaceutical recall notices, chemical impurities, and biological contamination.
FDA DrugsWegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4501-14
Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4501-14
Presence of Particulate Matter: Hair was found in a prefilled syringe
FDA DrugstraZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
FDA DrugsWegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4505-14
Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4505-14
Presence of Particulate Matter: Hair was found in a prefilled syringe
FDA DrugsOndansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13
Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-157-13
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.
FDA DrugsBD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29
BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29
Lack of Assurance of Sterlity
AustraliaSubstitutions approved for shortage of Catapres (clonidine) 150 mcg tablets
Substitutions approved for shortage of Catapres (clonidine) 150 mcg tablets
The initial Serious Scarcity Substitution Instrument (SSSI) has been extended - refer to new medicine shortage alert: "Extension of substitution approval for shortage of Catapres (clonidine) 150 mcg t...
UKMHRA Safety Roundup: December 2025
MHRA Safety Roundup: December 2025
Summary of the latest safety advice for medicines and medical device users...
AustraliaShortage of Creon (pancreatic extract) capsules extended
Shortage of Creon (pancreatic extract) capsules extended
Supply constraints will apply to Creon 25,000 unit and 35,000 unit capsules until 30 June 2026....
UKClass 3 Medicines Recall: Activase Pharmaceuticals Limited, Prednisolone 5mg Soluble Tablets, EL(25)A/54
Class 3 Medicines Recall: Activase Pharmaceuticals Limited, Prednisolone 5mg Soluble Tablets, EL(25)A/54
Activase Pharmaceuticals Limited is recalling two batches of Prednisolone 5mg Soluble Tablets as a precautionary measure due to a limited number of reports of blister pockets becoming swollen over tim...
UKClass 2 Medicines Recall: Hameln Pharma Ltd, Clarithromycin 500 mg powder for concentrate for solution for infusion, EL(25)A/53
Class 2 Medicines Recall: Hameln Pharma Ltd, Clarithromycin 500 mg powder for concentrate for solution for infusion, EL(25)A/53
Hameln Pharma Ltd is recalling certain batches of Clarithromycin 500 mg powder for concentrate for solution for infusion....
UKClass 4 Medicines Defect Notification: Flamingo Pharma UK Ltd, Amitriptyline Hydrochloride 10mg, 25mg, 50mg Tablets, EL(25)A/52
Class 4 Medicines Defect Notification: Flamingo Pharma UK Ltd, Amitriptyline Hydrochloride 10mg, 25mg, 50mg Tablets, EL(25)A/52
Flamingo Pharma UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the products listed in this notification do not contain all the required safety information....
AustraliaBrahmi Vati tablets (Ayurvedic medicine)
Brahmi Vati tablets (Ayurvedic medicine)
Brahmi Vati tablets pose a serious risk to your health and should not be taken....
AustraliaManasamitra Vadakam tablets (Ayurvedic medicine)
Manasamitra Vadakam tablets (Ayurvedic medicine)
Manasamitra Vakakam tablets pose a serious risk to your health and should not be taken....
AustraliaKumar Kalyan Rasa tablets (Ayurvedic medicine)
Kumar Kalyan Rasa tablets (Ayurvedic medicine)
Kumar Kalyan Rasa tablets pose a serious risk to your health and should not be taken....
AustraliaProduct warnings updated for GLP-1 RA class
Product warnings updated for GLP-1 RA class
We have updated the product warnings for GLP-1 and dual GIP/GLP-1 receptor agonists for two separate safety issues. This relatively new and high-profile class of medicines is used to treat type 2 diab...
UKMHRA Safety Roundup: November 2025
MHRA Safety Roundup: November 2025
Summary of the latest safety advice for medicines and medical device users...
UKClass 4 Medicines Defect Notification: Special Concept Development UK Limited, Baclofen 10mg Tablets, EL(25)A/51
Class 4 Medicines Defect Notification: Special Concept Development UK Limited, Baclofen 10mg Tablets, EL(25)A/51
Special Concept Development UK Limited has informed the MHRA that the Patient Information Leaflet (PIL) for the batches listed in this notification do not contain the correct safety information....
UKClass 4 Medicines Defect Notification: Lexon UK Ltd, Moclobemide 150mg tablets, EL(25)A/50
Class 4 Medicines Defect Notification: Lexon UK Ltd, Moclobemide 150mg tablets, EL(25)A/50
Lexon UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification is missing important updated safety information....
UKClass 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Fingolimod SUN 0.5mg hard capsules, EL(25)A/49
Class 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Fingolimod SUN 0.5mg hard capsules, EL(25)A/49
Sun Pharma UK Limited is conducting a precautionary recall of a single batch of Fingolimod SUN 0.5 mg hard capsules due to reports of capsule breakage on removing from the blister. No other batches of...
UKClass 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Atorvastatin 20mg and 80mg Film-coated Tablets, EL(25)A/48
Class 3 Medicines Recall: Sun Pharmaceutical Industries Limited, Atorvastatin 20mg and 80mg Film-coated Tablets, EL(25)A/48
Sun Pharma UK Limited are recalling the batches of tablets specified in the table as a precautionary measure due to failing dissolution test results reported during ongoing stability studies....
UKClass 3 Medicines Recall: Zambon SpA, Emylif 50mg orodispersible film, EL(25)A/47
Class 3 Medicines Recall: Zambon SpA, Emylif 50mg orodispersible film, EL(25)A/47
Zambon SpA is recalling an affected batch as a precautionary measure due to out of specification results for unknown impurities during ongoing stability testing....
UKMHRA Safety Roundup: October 2025
MHRA Safety Roundup: October 2025
Summary of the latest safety advice for medicines and medical device users...
UKClass 2 Medicines Recall: Baxter Healthcare Limited, Compound Sodium Lactate Solution for Infusion BP (Hartmann's Solution for infusion) in Viaflo 1000ml, EL(25)A/46
Class 2 Medicines Recall: Baxter Healthcare Limited, Compound Sodium Lactate Solution for Infusion BP (Hartmann's Solution for infusion) in Viaflo 1000ml, EL(25)A/46
Baxter Healthcare is recalling one batch of Compound Sodium Lactate (Hartmann’s Solution) 1000mL. This is due to a packaging error where some cartons labelled as Hartmann’s Solution may contain Ringer...
UKClass 4 Medicines Defect Notification: Relonchem Ltd, Various Products, EL(25)A/44
Class 4 Medicines Defect Notification: Relonchem Ltd, Various Products, EL(25)A/44
Relonchem Ltd has informed the MHRA that duplicate GTIN numbers have been assigned to certain Losartan potassium/Hydrochlorothiazide coated tablets in error and a duplicate EAN number has been assigne...