Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on February 06, 2026 and include a total of 17370 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0294-2026 | 01-16-2026 | Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-02 | Subpotent Drug | Specialty Process Labs LLC / 58 gms | Class II | Ongoing |
| D-0293-2026 | 01-10-2026 | Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ 08816, Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, India, NDC 64980-563-10. Package NDCs: 64980-562-01; 64980-562-10; 64980-563-01; 64980-563-10; 64980-564-01; 64980-564-50 | Presence of Foreign Substance | Graviti Pharmaceuticals Private Limited / 4212 bottles | Class II | Ongoing |
| D-0260-2026 | 01-06-2026 | AQ 120 GFEW, Aquarion Preserved Cartridges (2) 3.7 Gallons each | cGMP deviations. | Encon Safety Products Co / 7677 bags | Class II | Ongoing |
| D-0290-2026 | 01-02-2026 | 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 Package NDCs: 69097-880-67; 69097-890-67; 69097-870-67 | Presence of Particulate Matter. | Cipla USA, Inc. / 15,221 syringes | Class II | Ongoing |
| D-0259-2026 | 12-31-2025 | 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. Package NDCs: 47781-640-90; 47781-640-10; 47781-643-90; 47781-643-10; 47781-646-90; 47781-646-10; 47781-649-90; 47781-649-10; 47781-651-90; 47781-651-10; 47781-654-90; 47781-654-10; 47781-657-90; 47781-657-10; 47781-659-90; 47781-659-10; 47781-662-90; 47781-662-10; 47781-665-90; 47781-665-10; 47781-668-90; 47781-668-10; 47781-671-90; 47781-671-10 | Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets. | Alvogen, Inc / | Class II | Ongoing |
| D-0292-2026 | 12-31-2025 | 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 Package NDCs: 50268-709-11; 50268-709-15; 50268-710-11; 50268-710-15; 50268-711-11; 50268-711-15 | Out of specification for dissolution. | AvKARE / 7,991 5x10 cartons | Class II | Ongoing |
| D-0295-2026 | 12-30-2025 | Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07 | Subpotent Drug: Due oxidation caused by leakage of the contents of the Icosapent Ethyl 1g capsules. Use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients. | Zydus Pharmaceuticals (USA) Inc / 22,896 bottles | Class II | Ongoing |
| D-0256-2026 | 12-30-2025 | 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 Package NDCs: 51672-1365-2; 51672-1365-4 | Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D. | SUN PHARMACEUTICAL INDUSTRIES INC / 24,624 bottles | Class III | Ongoing |
| D-0246-2026 | 12-30-2025 | 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 Package NDCs: 68462-105-33; 68462-105-30; 68462-106-33; 68462-106-30; 68462-157-13; 68462-158-11; 68462-158-13 | 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. | Glenmark Pharmaceuticals Inc., USA / 96,948 packs | Class II | Ongoing |
| D-0275-2026 | 12-26-2025 | PEPTO BISMOL 32CT | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0261-2026 | 12-26-2025 | 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. | GOLD STAR DISTRIBUTION INC / Unkown | Class II | Ongoing |
| D-0278-2026 | 12-26-2025 | 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. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0271-2026 | 12-26-2025 | MOTRIN 2'S DISP.- 50CT | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0270-2026 | 12-26-2025 | EXCEDRIN MIGRAINE 2'S- 25 CT | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0277-2026 | 12-26-2025 | 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. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0283-2026 | 12-26-2025 | Personal Care, Vaporizing Chest Rub, 4 oz, 12 count, UPC 048155903319 | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / Unknown | Class II | Ongoing |
| D-0276-2026 | 12-26-2025 | PEPCID COMPLETE - 25CT | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0279-2026 | 12-26-2025 | 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. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0280-2026 | 12-26-2025 | Swan, White Clear Alcohol, 50%, 16oz, 12 count | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / Unknown | Class II | Ongoing |
| D-0284-2026 | 12-26-2025 | LUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989 | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / Unknown | Class II | Ongoing |
| D-0287-2026 | 12-26-2025 | 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. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0286-2026 | 12-26-2025 | 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, 150ML; j) AXE, BODY SPRAY, ICE CHILL, 6CT, 150ML; k) AXE, BODY SPRAY, MUSK, 6CT, 150ML; l) AXE, DEODORANT SPRAY, ADRENALIN, 6CT, 150ML | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0282-2026 | 12-26-2025 | 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. | GOLD STAR DISTRIBUTION INC / Unknown | Class II | Ongoing |
| D-0285-2026 | 12-26-2025 | 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) Personal Care, CREAMY COCOA PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155922242; h) SOFTEE, PETROLEUM JELLY, 5oz, 12CT, UPC: 096002007208 | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / Unknown | Class II | Ongoing |
| D-0268-2026 | 12-26-2025 | LIQUID DAYQUIL 12/8oz | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0273-2026 | 12-26-2025 | NYQUIL COLD & FLU -32CT/2PK | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0262-2026 | 12-26-2025 | Aleve 1's, 60 CT | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0266-2026 | 12-26-2025 | Claritin, 20 Count, UPC: 655708016305 | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / Unknown | Class II | Ongoing |
| D-0281-2026 | 12-26-2025 | Personal Care, Ice Gel, 8oz, 12 count, UPC 048155903463 | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / Unknown | Class II | Ongoing |
| D-0272-2026 | 12-26-2025 | LIQUID NYQUIL a) regular, 12/8oz; b) cherry, 12/8oz | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0267-2026 | 12-26-2025 | DAYQUIL COLD & FLU, 32CT/2PK | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / Unknown | Class II | Ongoing |
| D-0269-2026 | 12-26-2025 | EXCEDRIN 2'S DISP.- 30 CT | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0263-2026 | 12-26-2025 | 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. | GOLD STAR DISTRIBUTION INC / Unknown | Class II | Ongoing |
| D-0274-2026 | 12-26-2025 | CHILDREN NYQUIL, COLD&FLU, BERRY, 8oz, 12ct | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0265-2026 | 12-26-2025 | Bayer 2Pk- 25 CT | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0264-2026 | 12-26-2025 | Benadryl, 25'S 2PK Box, UPC 815556020316 | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC / | Class II | Ongoing |
| D-0291-2026 | 12-22-2025 | Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39 Package NDCs: 76282-103-39 | Failed PH Specifications | Cipla USA, Inc. / 92,376 tubes | Class III | Ongoing |
| D-0245-2026 | 12-19-2025 | 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 Package NDCs: 0169-4525-01; 0169-4525-14; 0169-4525-90; 0169-4525-94; 0169-4505-01; 0169-4505-14; 0169-4501-01; 0169-4501-14; 0169-4517-01; 0169-4517-14; 0169-4524-01; 0169-4524-14; 0169-4415-31; 0169-4415-92; 0169-4404-31; 0169-4409-31; 0169-4425-31 | Presence of Particulate Matter: Hair was found in a prefilled syringe | Novo Nordisk Inc. / N/A | Class II | Ongoing |
| D-0244-2026 | 12-19-2025 | 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 Package NDCs: 0169-4525-01; 0169-4525-14; 0169-4525-90; 0169-4525-94; 0169-4505-01; 0169-4505-14; 0169-4501-01; 0169-4501-14; 0169-4517-01; 0169-4517-14; 0169-4524-01; 0169-4524-14; 0169-4415-31; 0169-4415-92; 0169-4404-31; 0169-4409-31; 0169-4425-31 | Presence of Particulate Matter: Hair was found in a prefilled syringe | Novo Nordisk Inc. / N/A | Class II | Ongoing |
| D-0247-2026 | 12-19-2025 | 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 Package NDCs: 68382-805-01; 68382-805-30; 68382-805-77; 68382-805-05; 68382-805-10; 68382-805-06; 68382-805-16; 68382-806-06; 68382-806-16; 68382-806-01; 68382-806-05; 68382-806-10; 68382-806-30; 68382-806-77; 68382-807-06; 68382-807-16; 68382-807-01; 68382-807-05; 68382-807-10; 68382-807-30; 68382-807-77; 68382-808-06; 68382-808-16; 68382-808-01; 68382-808-05; 68382-808-10; 68382-808-30; 68382-808-77; 68382-609-01; 68382-609-05; 68382-609-10; 68382-610-01; 68382-610-05; 68382-610-10 | Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface. | Zydus Pharmaceuticals (USA) Inc / 2,136 1000-count bottles | Class III | Ongoing |
| D-0251-2026 | 12-18-2025 | 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. | Imprimis NJOF, LLC / 314 boxes of 6,280 pre-filled syringes | Class II | Ongoing |
| D-0250-2026 | 12-18-2025 | 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. | Imprimis NJOF, LLC / 596 boxes of 11,920 pre-filled syringes | Class II | Ongoing |
| D-0249-2026 | 12-18-2025 | 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. | Imprimis NJOF, LLC / 778 boxes of 15,540 pre-filled syringes | Class II | Ongoing |
| D-0243-2026 | 12-17-2025 | 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 Package NDCs: 54365-401-28; 54365-401-29 | Lack of Assurance of Sterlity | CareFusion 213, LLC / 106,400 units | Class II | Ongoing |
| D-0248-2026 | 12-16-2025 | 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 Package NDCs: 62332-175-30; 62332-175-90; 62332-175-91; 62332-175-10; 62332-176-30; 62332-176-90; 62332-176-91; 62332-176-10; 2405003360 | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. | Alembic Pharmaceuticals Limited / | Class III | Ongoing |
| D-0254-2026 | 12-16-2025 | Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01. Package NDCs: 0406-0512-01; 0406-0512-05; 0406-0512-62; 0406-0512-23; 0406-0512-91; 0406-0522-01; 0406-0522-62; 0406-0522-05; 0406-0522-23; 0406-0523-01; 0406-0523-62; 0406-0523-05; 0406-0523-23 | Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. | SpecGx, LLC / 287,988 Bottles. | Class II | Ongoing |
| D-0255-2026 | 12-16-2025 | 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 Package NDCs: 0406-0512-01; 0406-0512-05; 0406-0512-62; 0406-0512-23; 0406-0512-91; 0406-0522-01; 0406-0522-62; 0406-0522-05; 0406-0522-23; 0406-0523-01; 0406-0523-62; 0406-0523-05; 0406-0523-23; 0406052201 | Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. | SpecGx, LLC / 74,544 bottles | Class II | Ongoing |
| D-0288-2026 | 12-12-2025 | 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 Package NDCs: 62795-4005-9; 7876471018 | Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter. | Medinatura New Mexico, inc. / | Class I | Ongoing |
| D-0289-2026 | 12-12-2025 | 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 Package NDCs: 62795-4006-9; 7876471018 | Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter. | Medinatura New Mexico, inc. / | Class I | Ongoing |
| D-0241-2026 | 12-12-2025 | Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Only, Manufactured for: Merck Sharpe & Dohme LLC, Rahway, NJ 07065, USA, Manufactured by: Novo Nordisk Production Ireland Limited Athlone, Ireland, NDC 0006-3066-03 Package NDCs: 0006-0461-02; 0006-0461-01; 0006-0461-06; 0006-0461-12; 0006-0462-01; 0006-0462-06; 0006-3862-03; 0006-3862-13; 0006-0464-01; 0006-0464-10; 0006-0464-05; 0006-3066-01; 0006-3066-03 | Presence of particulate matter: potential presence of metal particulates in the product. | Merck Sharp & Dohme LLC / 3 - single dose kits | Class II | Ongoing |
| D-0242-2026 | 12-12-2025 | Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg, 8 packets per carton, Rx Only, Manufactured for: Merck Sharp & Doohme LLC, Rahway, NJ 07056 USA, Manufactured by: N.V. Organon, 5349 AB Oss, The Netherlands, a subsidiary of Organon & Co., Jersey City, NJ 07302, USA NDC 0085-2224-02. Package NDCs: 0085-1328-01; 0085-4324-02; 0085-4331-01; 0085-2224-01; 0085-2224-02 | Presence of particulate matter: potential presence of metal particulates in the product. | Merck Sharp & Dohme LLC / 845 kits | Class II | Ongoing |
| D-0240-2026 | 12-09-2025 | Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08 | Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint | SUN PHARMA /TARO / 17,664 units | Class II | Ongoing |
| D-0252-2026 | 12-08-2025 | ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA | cGMP Deviations | Signature Formulations, LLC / 570 bottles | Class II | Ongoing |
| D-0253-2026 | 12-08-2025 | ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA | cGMP Deviations | Signature Formulations, LLC / 1,458 containers | Class II | Ongoing |
| D-0236-2026 | 11-26-2025 | Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-dose 5 mL vial NDC 70069-141-01; 10x5 mL single dose vial per Carton NDC 70069-141-10. Package NDCs: 70069-141-01; 70069-141-10; 70069-151-01; 70069-151-10 | Subpotent product:out of specification assay results observed during long term stability testing. | SOMERSET THERAPEUTICS LLC / 52,340 5mL vials | Class III | Ongoing |
| D-0238-2026 | 11-26-2025 | Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial, NDC 70069-161-01; 10x10mL Multiple-dose vials per Carton, NDC 70069-161-01. Package NDCs: 70069-161-01; 70069-161-10 | Subpotent product:out of specification assay results observed during long term stability testing. | SOMERSET THERAPEUTICS LLC / 71,310 10mL vials | Class III | Ongoing |
| D-0223-2026 | 11-26-2025 | Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, Winder, GA 30680. NDC: 75826-131-01 Package NDCs: 75826-129-05; 75826-129-17; 75826-130-05; 75826-130-17; 75826-131-15; 75826-131-04; 75826-131-01 | Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton. | Winder Laboratories, LLC / 3,528 30 mL Bottles | Class III | Ongoing |
| D-0257-2026 | 11-26-2025 | 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 Package NDCs: 51672-4081-3; 51672-4081-4 | Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay. | SUN PHARMACEUTICAL INDUSTRIES INC / | Class III | Ongoing |
| D-0237-2026 | 11-26-2025 | Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70069-151-01; 10 x 20 Single dose vials per Carton, NDC 70069-151-10. Package NDCs: 70069-141-01; 70069-141-10; 70069-151-01; 70069-151-10 | Subpotent product:out of specification assay results observed during long term stability testing. | SOMERSET THERAPEUTICS LLC / 28,660 20mL vials | Class III | Ongoing |
| D-0235-2026 | 11-26-2025 | Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10 Package NDCs: 51407-972-01; 51407-973-01; 51407-973-10; 51407-974-01; 51407-974-10 | Presence of Foreign Tablets/Capsules | Golden State Medical Supply Inc. / 2472 HDPE Bottles | Class II | Ongoing |
| D-0216-2026 | 11-24-2025 | Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10. Package NDCs: 51991-746-06; 51991-746-90; 51991-746-05; 51991-747-33; 51991-747-90; 51991-747-10; 51991-748-33; 51991-748-90; 51991-748-10; 51991-750-33; 51991-750-90; 51991-750-05; 51991-750-10 | CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit | Breckenridge Pharmaceutical, Inc. / 7389 bottles | Class II | Ongoing |
| D-0215-2026 | 11-24-2025 | Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10. Package NDCs: 82009-029-05; 82009-030-10; 82009-032-10; 82009-031-30; 82009-031-90 | CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit | Breckenridge Pharmaceutical, Inc. / 3397 bottles | Class II | Ongoing |
| D-0199-2026 | 11-21-2025 | Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. Package NDCs: 68462-878-30; 68462-878-01; 68462-878-05; 68462-879-30; 68462-879-01; 68462-879-05; 68462-880-30; 68462-880-01; 68462-880-05 | Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe | Glenmark Pharmaceuticals Inc., USA / 11,136 bottles | Class III | Ongoing |
| D-0221-2026 | 11-20-2025 | Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67226. NDC: 71266-8240-01 | Incorrect Product Formulation | Fagron Compounding Services / 2980 syringes | Class II | Ongoing |
| D-0222-2026 | 11-18-2025 | Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 38478, Product of Italy, NDC 42291-874-90. Package NDCs: 42291-871-30; 42291-872-90; 42291-873-90; 42291-874-90 | Cross Contamination with Other Products | Glenmark Pharmaceuticals Inc., USA / 672 90-count bottles | Class III | Ongoing |
| D-0239-2026 | 11-17-2025 | Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited, Repackaged by Preferred Pharmaceuticals NDC 68788-8666-01 | 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. | Preferred Pharmaceuticals, Inc. / 575 1x10 Foil Blister Packs | Class II | Ongoing |
| D-0224-2026 | 11-14-2025 | Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02 Package NDCs: 69097-410-02; 69097-411-02; 69097-412-02 | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. | Cipla USA, Inc. / 63,504 bottles | Class II | Ongoing |
| D-0225-2026 | 11-14-2025 | Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02 Package NDCs: 69097-410-02; 69097-411-02; 69097-412-02 | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. | Cipla USA, Inc. / 15,744 bottles | Class II | Ongoing |
| D-0226-2026 | 11-14-2025 | Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02 Package NDCs: 69097-410-02; 69097-411-02; 69097-412-02 | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. | Cipla USA, Inc. / 12,576 bottles | Class II | Ongoing |
| D-0220-2026 | 11-13-2025 | Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-274-01 Package NDCs: 70748-274-01 | Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity. | Lupin Pharmaceuticals Inc. / 32736 vials | Class II | Ongoing |
| D-0179-2026 | 11-12-2025 | Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, NDC 0363-3114-01 | Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis | Medical Products Laboratories, Inc. / 41,328 bottles | Class II | Ongoing |
| D-0219-2026 | 11-11-2025 | Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56 Package NDCs: 43598-907-56; 43598-908-56; 43598-023-53; 43598-022-56 | Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit. | Dr. Reddy's Laboratories, Inc. / 4800 54-count bottles | Class III | Ongoing |
| D-0198-2026 | 11-07-2025 | Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17. Package NDCs: 0591-2921-18; 0591-2921-02; 0591-3216-17; 0591-3216-30; 0591-3217-26; 0591-3217-30 | Defective Container - A defect in the side-seal which allows leakage of product. | Teva Pharmaceuticals USA, Inc / 15,944 cartons | Class III | Ongoing |
| D-0182-2026 | 11-06-2025 | Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale). Package NDCs: 63323-739-11; 63323-739-12 | Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. | Fresenius Kabi USA, LLC / 2,199,850 vials | Class I | Ongoing |
| D-0227-2026 | 11-05-2025 | Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09. Package NDCs: 68180-351-08; 68180-351-06; 68180-351-09; 68180-351-03; 68180-351-01; 68180-352-11; 68180-352-01; 68180-352-03; 68180-352-06; 68180-352-09; 68180-352-02; 68180-352-05; 68180-353-11; 68180-353-01; 68180-353-03; 68180-353-02; 68180-353-06; 68180-353-09; 68180-353-05; 68180-978-01; 68180-978-02; 68180-978-03; 68180-986-04; 68180-986-02; 68180-986-01; 68180-986-03; 68180-992-04; 68180-992-01; 68180-992-02; 68180-992-03 | Defective container - seal not adhering to bottles | Lupin Pharmaceuticals Inc. / 52,128 bottles | Class II | Ongoing |
| D-0203-2026 | 10-31-2025 | Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA, Made in India, NDC 67777-402-01. Package NDCs: 67777-402-01; 67777-402-02 | cGMP deviations | Blossom Pharmaceuticals / 18912 containers | Class II | Ongoing |
| D-0206-2026 | 10-31-2025 | Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, Manufactured for: Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, NDC 75834-170-15. Package NDCs: 75834-170-01; 75834-170-02; 75834-170-15 | cGMP deviations | Blossom Pharmaceuticals / 912 containers | Class II | Ongoing |
| D-0229-2026 | 10-31-2025 | Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Patterson Dental Supply, Inc., 1031 Mendota Heights Road, Saint Paul, MN55120, Manufactured by: Novocol Pharmaceutical of Canada, Inc., NDC 50227-1030-5. Package NDCs: 50227-1030-5 | Defective container: cracked/broken cartridges | Novocol Pharmaceutical of Canada, Inc. / 12,033 cartons | Class II | Ongoing |
| D-0232-2026 | 10-31-2025 | Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distributed by Benco Dental 295 Center Point Blvd, Pittston, PA 18640, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66975-406-51. Package NDCs: 66975-406-51 | Defective container: cracked/broken cartridges | Novocol Pharmaceutical of Canada, Inc. / | Class II | Ongoing |
| D-0233-2026 | 10-31-2025 | Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Single-Dose Cartridges, 1.7 mL, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0753-05. Package NDCs: 0362-0753-05 | Defective container: cracked/broken cartridges | Novocol Pharmaceutical of Canada, Inc. / 40 cartons | Class II | Ongoing |
| D-0231-2026 | 10-31-2025 | darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66467-9760-5. Package NDCs: 66467-9760-5 | Defective container: cracked/broken cartridges | Novocol Pharmaceutical of Canada, Inc. / 5,520 Cartons | Class II | Ongoing |
| D-0234-2026 | 10-31-2025 | OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Rx only, Made in Canada by Novocol Pharmaceutical of Canada, Inc., Distributed by Septodont, Inc., Louisville, Co, 80027, NDC 0362-0101-10 Package NDCs: 0362-0101-10 | Defective container: cracked/broken cartridges | Novocol Pharmaceutical of Canada, Inc. / 1,636 cartons | Class II | Ongoing |
| D-0208-2026 | 10-31-2025 | Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in India, NDC 75834-170-01. Package NDCs: 75834-170-01; 75834-170-02; 75834-170-15 | cGMP deviations | Blossom Pharmaceuticals / 13536 containers | Class II | Ongoing |
| D-0211-2026 | 10-31-2025 | Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, USA, NDC 69396-087-55. Package NDCs: 69396-087-01; 69396-087-55 | cGMP deviations | Blossom Pharmaceuticals / 14700 bottles | Class II | Ongoing |
| D-0209-2026 | 10-31-2025 | Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, Made in India, NDC 75834-170-02. Package NDCs: 75834-170-01; 75834-170-02; 75834-170-15 | cGMP deviations | Blossom Pharmaceuticals / 7920 bottles | Class II | Ongoing |
| D-0201-2026 | 10-31-2025 | Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 USA, Made in India, UPC 616784126319. | cGMP deviations | Blossom Pharmaceuticals / 9600 containers | Class II | Ongoing |
| D-0205-2026 | 10-31-2025 | WeCare, Zinc Oxide Ointment, Net Wt. 15 oz/425 g, Manuactured for: Dynarex Corporation, 11 Dynarex Drive, Middletown, NY 10941, Made in India, NDC 67777-223-05. Package NDCs: 67777-223-01; 67777-223-11; 67777-223-02; 67777-223-03; 67777-223-13; 67777-223-04; 67777-223-05; 67777-223-06 | cGMP deviations | Blossom Pharmaceuticals / 2592 bottles | Class II | Ongoing |
| D-0204-2026 | 10-31-2025 | Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for: Dynarex Corporation, 16 Glenshaw Street, Orangeburg, NY 10962, UPC 61784128016. | cGMP deviations | Blossom Pharmaceuticals / 8184 bottles | Class II | Ongoing |
| D-0210-2026 | 10-31-2025 | Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301 USA, Made in India, NDC 69396-087-01. Package NDCs: 69396-087-01; 69396-087-55 | cGMP deviations | Blossom Pharmaceuticals / 12150 bottles | Class II | Ongoing |
| D-0207-2026 | 10-31-2025 | Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10852, USA, Made in India, NDC 67777-407-03. Package NDCs: 67777-407-01; 67777-407-02; 67777-407-03; 67777-407-10; 67777-407-04; 67777-407-11 | cGMP deviations | Blossom Pharmaceuticals / 7944 containers | Class II | Ongoing |
| D-0212-2026 | 10-31-2025 | Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceuticals USA 101 NE, Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, NDC 69396-086-02. Package NDCs: 69396-086-02 | cGMP deviations | Blossom Pharmaceuticals / 33000 containers | Class II | Ongoing |
| D-0202-2026 | 10-31-2025 | Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA, Made in India, NDC 67777-407-04. Package NDCs: 67777-407-01; 67777-407-02; 67777-407-03; 67777-407-10; 67777-407-04; 67777-407-11 | cGMP deviations | Blossom Pharmaceuticals / 1560 containers | Class II | Ongoing |
| D-0213-2026 | 10-31-2025 | Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04. Package NDCs: 67777-234-02; 67777-234-01; 67777-234-04; 67777-234-03 | cGMP deviations | Blossom Pharmaceuticals / 2400 containers | Class II | Ongoing |
| D-0197-2026 | 10-31-2025 | Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc. Warren, NJ 07059. Vial NDC# 69097-708-31; Carton NDC 69097-708-96 Package NDCs: 69097-709-96; 69097-708-96; 69097-708-31 | Failed Stability Specifications: Observed OOS results: eg results for colour index | Cipla Limited / 4,438 10x1mL cartons | Class II | Ongoing |
| D-0230-2026 | 10-31-2025 | 3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-441-16. Package NDCs: 66312-441-16 | Defective container: cracked/broken cartridges | Novocol Pharmaceutical of Canada, Inc. / 5,825 | Class II | Ongoing |
| D-0228-2026 | 10-31-2025 | 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-176-16. Package NDCs: 66312-181-16; 66312-176-16 | Defective container: cracked/broken cartridges | Novocol Pharmaceutical of Canada, Inc. / 18,789 cartons- 50 cartridges /carton | Class II | Ongoing |
| D-0181-2026 | 10-29-2025 | POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26 Package NDCs: 0990-7074-26; 0990-7075-14; 0990-7075-26; 0990-7077-14; 0990-7077-26 | Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq | Otsuka ICU Medical LLC / | Class I | Ongoing |
| D-0180-2026 | 10-29-2025 | POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7077-14 Package NDCs: 0990-7074-26; 0990-7075-14; 0990-7075-26; 0990-7077-14; 0990-7077-26 | Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq | Otsuka ICU Medical LLC / 21,696 50mL flexible containers | Class I | Ongoing |
| D-0150-2026 | 10-28-2025 | Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-052-88. Package NDCs: 57664-047-88; 57664-046-88; 57664-048-88; 57664-049-88; 57664-050-88; 57664-051-88; 57664-052-88; 57664-083-88; 57664-084-88; 57664-085-88; 57664-086-88; 57664-087-88; 57664-088-88 | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. | SUN PHARMACEUTICAL INDUSTRIES INC / N/A | Class II | Ongoing |
| D-0144-2026 | 10-28-2025 | Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-046-88. Package NDCs: 57664-047-88; 57664-046-88; 57664-048-88; 57664-049-88; 57664-050-88; 57664-051-88; 57664-052-88; 57664-083-88; 57664-084-88; 57664-085-88; 57664-086-88; 57664-087-88; 57664-088-88 | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. | SUN PHARMACEUTICAL INDUSTRIES INC / N/A | Class II | Ongoing |
