Arzneimittel & Medikamente Recalls
Pharmaceutical recall notices, chemical impurities, and biological contamination.
UKMHRA Safety Roundup: January 2026
MHRA Safety Roundup: January 2026
Summary of the latest safety advice for medicines and medical device users...
AustraliaNew Presolol (labetalol) tablet shortage: substitution instrument and overseas-registered alternative approved
New Presolol (labetalol) tablet shortage: substitution instrument and overseas-registered alternative approved
PRESOLOL 200 TABLET SHORTAGE HAS RESOLVED....
FDA DrugsTYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM, 50CT; e) SINUS SEVERE, 2PK, 50CT
TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM, 50CT; e) SINUS SEVERE, 2PK, 50CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DrugsPersonal Care, Vaporizing Chest Rub, 4 oz, 12 count, UPC 048155903319
Personal Care, Vaporizing Chest Rub, 4 oz, 12 count, UPC 048155903319
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DrugsMOTRIN 2'S DISP.- 50CT
MOTRIN 2'S DISP.- 50CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DrugsEXCEDRIN MIGRAINE 2'S- 25 CT
EXCEDRIN MIGRAINE 2'S- 25 CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DrugsAleve 1's, 60 CT
Aleve 1's, 60 CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DrugsTUMS a) Assorted, 12 Ct.; b) Extra Strength (EX) Assorted Berries, 12-count #1194A *05/27; c)Extra Strength (EX) Assorted Fruit, 12-count, #1194C *03/27
TUMS a) Assorted, 12 Ct.; b) Extra Strength (EX) Assorted Berries, 12-count #1194A *05/27; c)Extra Strength (EX) Assorted Fruit, 12-count, #1194C *03/27
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
UKClass 3 Medicines Recall: Glenmark Pharmaceuticals Europe Limited, Fingolimod Glenmark 0.5 mg Hard Capsules, EL(26)A/02
Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Limited, Fingolimod Glenmark 0.5 mg Hard Capsules, EL(26)A/02
Glenmark Pharmaceuticals Europe Limited is recalling one batch after stability testing showed out-of-specification results. The batch is being recalled as a precautionary measure following test result...
FDA DrugsNYQUIL COLD & FLU -32CT/2PK
NYQUIL COLD & FLU -32CT/2PK
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DrugsPersonal Care, Ice Gel, 8oz, 12 count, UPC 048155903463
Personal Care, Ice Gel, 8oz, 12 count, UPC 048155903463
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DrugsEXCEDRIN 2'S DISP.- 30 CT
EXCEDRIN 2'S DISP.- 30 CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DrugsPEPCID COMPLETE - 25CT
PEPCID COMPLETE - 25CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DrugsCHILDREN NYQUIL, COLD&FLU, BERRY, 8oz, 12ct
CHILDREN NYQUIL, COLD&FLU, BERRY, 8oz, 12ct
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DrugsHalls Cough Drops a) BAGS, MENTHOL, 12CT; b) BAGS, HONEY LEM, 12CT; c) BAGS, DEFENSE CITRUS, 12CT; d) BAGS, CHERRY, 12CT; e) M. CHERRY, 20 STK; f) BRAZIL, Cherry, 21CT/27.5G; f) LEMON. HONEY, 20CT #1180E; g) LIME FRESH, 20CT, #1182; h) MENTHOL BLUE, 20CT, #1180A; i) BRAZIL, Menthol, 21CT/27.5G, j) M . STRAWBERRY, 20 STK; k) DEFENSE, VITAMIN C, 20CT, #1181
Halls Cough Drops a) BAGS, MENTHOL, 12CT; b) BAGS, HONEY LEM, 12CT; c) BAGS, DEFENSE CITRUS, 12CT; d) BAGS, CHERRY, 12CT; e) M. CHERRY, 20 STK; f) BRAZIL, Cherry, 21CT/27.5G; f) LEMON. HONEY, 20CT #1180E; g) LIME FRESH, 20CT, #1182; h) MENTHOL BLUE, 20CT, #1180A; i) BRAZIL, Menthol, 21CT/27.5G, j) M . STRAWBERRY, 20 STK; k) DEFENSE, VITAMIN C, 20CT, #1181
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DrugsLevothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah, IA, 51601 USA, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC: 47781-662-10.
Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah, IA, 51601 USA, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC: 47781-662-10.
Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
FDA DrugsFluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
FDA DrugsPEPTO BISMOL 32CT
PEPTO BISMOL 32CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DrugsAQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each
AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each
cGMP deviations.
FDA DrugsLIQUID NYQUIL a) regular, 12/8oz; b) cherry, 12/8oz
LIQUID NYQUIL a) regular, 12/8oz; b) cherry, 12/8oz
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DrugsClaritin, 20 Count, UPC: 655708016305
Claritin, 20 Count, UPC: 655708016305
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DrugsAlka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packet in 36 count box, UPC: 016500594932
Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packet in 36 count box, UPC: 016500594932
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA DrugsLanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67
Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67
Presence of Particulate Matter.
FDA DrugsBayer 2Pk- 25 CT
Bayer 2Pk- 25 CT
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.