FDA Drug Recalls in 2026

99 recalls found

January 2026

FDA

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

LIQUID DAYQUIL 12/8oz

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA

EXCEDRIN MIGRAINE 2'S- 25 CT

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA

Swan, White Clear Alcohol, 50%, 16oz, 12 count

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA

Petroleum jelly: a) Vaseline Petroleum Jelly, 1.75, 12CT, UPC: 6001085120946; b) Vaseline Men Cooling Petroleum Jelly, 100ML, 12CT, UPC: 60022141; c) Vaseline Vitamin E, Petroleum Jelly, 100ML, 12CT, UPC: 6001085121028; MEN FRESH PETROLEUM JELLY, 100ML, 12CT, UPC: 60022127; d) Lucky Petroleum Jelly, 6 OZ, 12 PK, UPC: 808829081466;048155903562; e) Lucky Petroleum Jelly, COCOA, 6oz, 12ct, UPC: 808829081572, 048155922150; f) Personal Care, CREAMY PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155908642; g)

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA

Personal Care, Vaporizing Chest Rub, 4 oz, 12 count, UPC 048155903319

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA

Aleve 1's, 60 CT

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA

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.
FDA

MOTRIN 2'S DISP.- 50CT

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA

LUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA

Personal Care, Ice Gel, 8oz, 12 count, UPC 048155903463

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA

EXCEDRIN 2'S DISP.- 30 CT

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA

Toothpaste: a) COLGATE, TOOTHPASTE, WHITENING, 2.5oz, 24ct; UPC: 035000511065; b) COLGATE, TOOTHPASTE, Regular, 2.5oz, 24ct, UPC: 035000511058; c) COLGATE, TOOTHPASTE, TRIPLE, 2.5oz, 24ct, UPC: 035000512109; d) COLGATE, TOOTHPASTE, MINT ZING, 24CT, 2.5oz, UPC: 035000744609; COLGATE, MAXFRESH, SPICY FRESH, RED TOOTH PASTE, 72CT, 150G; e) CREST, TOOTHPASTE, 40CT, 8.2OZ, UPC: 037000247081

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA

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

Deodorant: a) Axe, Body Spray, Wild Spice, 6CT, 150ML, UPC: 600108736469; b) LUCKY MENS STICK DEODORANT, SPRING FRESH, 24CT, 2.5 OZ, UPC: 808829111668; c) LUCKY MENS STICK DEODORANT, FRESH COMFORT, 24CT, 1.6 OZ, UPC: 808829089103; d) LADY DEODORANT, CHERRY BLOSSOSM, 24CT, 1.8oz, UPC: 048155921092; e) AXE, BODY SPRAY, APOLLO, 6CT, 150ML; f) AXE, BODY SPRAY, BLACK, 6CT, 150ML; g) AXE, BODY SPRAY, DARK TEMPTATION, 6CT, 150ML; h) AXE, BODY SPRAY, GOLD, 6CT, 150ML; i) AXE, BODY SPRAY, EXCITE, 6CT, 1

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA

CHILDREN NYQUIL, COLD&FLU, BERRY, 8oz, 12ct

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA

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

Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual packets, UPC: 305730154895; b) PM, Ibuprofen, Dispenser Pack, 2 Caplet packets in box containing 50 packets, UPC: 305730164559

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA

PEPTO BISMOL 32CT

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA

Carmex a) jar, 12 count, UPC: 083078123154, 083078113155; b) Tube, PEG, 12 count, UPC: 083078123147, 083078113148

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA

AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each

cGMP deviations.
FDA

LIQUID NYQUIL a) regular, 12/8oz; b) cherry, 12/8oz

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA

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

NYQUIL COLD & FLU -32CT/2PK

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA

Claritin, 20 Count, UPC: 655708016305

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA

TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01

Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
FDA

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

Bayer 2Pk- 25 CT

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA

PEPCID COMPLETE - 25CT

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA

DAYQUIL COLD & FLU, 32CT/2PK

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA

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

Benadryl, 25'S 2PK Box, UPC 815556020316

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA

Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC# 51672-4081-4

Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
FDA

ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4006-9, UPC 787647101887

Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
FDA

Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.

Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
FDA

Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06.

Presence of particulate matter - Glass like particles.
FDA

ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4005-9, UPC 787647101863

Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
FDA

ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA

cGMP Deviations
FDA

Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493

Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
FDA

ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA

cGMP Deviations
FDA

Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15

Out of specification for dissolution.
FDA

Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
FDA

Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01.

Presence of particulate matter - Glass like particles.
FDA

Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1

Presence of particulate matter - Glass like particles.
FDA

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

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

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

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

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