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 October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| 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-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-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-0332-2026 | 12-22-2025 | Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313 | CGMP Deviations: product found to contain lead. | HANDELNINE GLOBAL LLC / 4 bottles /30 capsules each | Class I | 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-0296-2026 | 12-22-2025 | Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02. Package NDCs: 0338-0003-44; 0338-0003-46; 0338-0003-47; 0338-0004-02; 0338-0004-03; 0338-0004-04; 0338-0004-05 | Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution | Baxter Healthcare Corporation / 125,496 bottles | Class II | 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 | 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 | 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-0298-2026 | 12-19-2025 | INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01 Package NDCs: 49873-402-01 | Failed Disintegration Specifications: above the time expected. | Sato Pharmaceutical Co., Ltd / 3,640 bottles | Class II | 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-0300-2026 | 12-15-2025 | Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854, NDC 72205-070-72 Package NDCs: 72205-070-72 | Failed Impurities/Degradation Specifications | NOVADOZ PHARMACEUTICALS LLC / N/A | Class III | Ongoing |
| D-0397-2026 | 12-15-2025 | MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7 | Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil | StuffbyNainax / 4 | 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-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-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-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-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-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-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-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-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-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-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-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-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. | 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-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-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-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-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-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-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-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; 67777-407-12; 67777-407-13 | cGMP deviations | Blossom Pharmaceuticals / 7944 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; 67777-407-12; 67777-407-13 | cGMP deviations | Blossom Pharmaceuticals / 1560 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-0145-2026 | 10-28-2025 | Lisdexamfetamine Dimesylate Capsules, 20 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 57664-047-88. 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-0146-2026 | 10-28-2025 | Lisdexamfetamine Dimesylate Capsules, 30 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 57664-048-88. 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 |
| 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-0149-2026 | 10-28-2025 | Lisdexamfetamine Dimesylate Capsules, 60 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 57664-051-88. 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-0147-2026 | 10-28-2025 | Lisdexamfetamine Dimesylate Capsules, 40 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 57664-049-88. 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-0148-2026 | 10-28-2025 | Lisdexamfetamine Dimesylate Capsules, 50 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 57664-050-88. 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-0345-2026 | 10-28-2025 | Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 850065597027 | Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren | Agebox / N/A | Class II | Ongoing |
| D-0344-2026 | 10-28-2025 | Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX Inc., Wilmington, DE 19801 USA, UPC 8 50065 59701 0 | Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren | Agebox / 665 bottles | Class II | Ongoing |
| D-0143-2026 | 10-27-2025 | 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37 Package NDCs: 0990-7730-36; 0990-7730-37; 0990-7983-61; 0990-7983-02; 0990-7983-03; 0990-7983-09; 0990-7983-55; 0990-7983-53; 0990-7984-37; 0990-7984-20; 0990-7984-13; 0990-7984-23; 0990-7984-36; 0990-7985-02; 0990-7985-03; 0990-7985-09 | Lack of Assurance of Sterility: Potential for flexible container leaks. | Otsuka ICU Medical LLC / 509,360 100 mL bags | Class II | Ongoing |
| D-0218-2026 | 10-24-2025 | Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33422, Carton NDC 76282-478-90; Bottle NDC 76282-478-13. Package NDCs: 76282-476-45; 76282-476-90; 76282-477-15; 76282-477-90; 76282-478-13; 76282-478-90 | Failed stability specifications: Out of specification for hardness test | Cipla USA, Inc. / N/A | Class II | Ongoing |
| D-0217-2026 | 10-24-2025 | Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-936-98. Package NDCs: 69097-934-57; 69097-934-98; 69097-935-89; 69097-935-98; 69097-936-65; 69097-936-98 | Failed stability specifications: Out of specification for hardness test | Cipla USA, Inc. / 1180 boxes | Class II | Ongoing |
| D-0159-2026 | 10-23-2025 | Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. NDC 68382-110-06 Package NDCs: 68382-110-06; 68382-110-01 | Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules. | Zydus Pharmaceuticals (USA) Inc / 36,624 bottles | Class II | Ongoing |
| D-0154-2026 | 10-22-2025 | clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Package NDCs: 16714-849-02; 16714-849-01; 16714-849-03; 16714-850-01; 16714-850-03; 16714-850-02; 16714-851-01; 16714-851-03; 16714-851-02 | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0153-2026 | 10-22-2025 | clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India Package NDCs: 16714-849-02; 16714-849-01; 16714-849-03; 16714-850-01; 16714-850-03; 16714-850-02; 16714-851-01; 16714-851-03; 16714-851-02 | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0152-2026 | 10-22-2025 | clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India Package NDCs: 16714-849-02; 16714-849-01; 16714-849-03; 16714-850-01; 16714-850-03; 16714-850-02; 16714-851-01; 16714-851-03; 16714-851-02 | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0121-2026 | 10-21-2025 | TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034, NDC: 50580-378-04. Package NDCs: 50580-378-01; 50580-378-02; 50580-378-03; 50580-378-04; 50580-378-05; 50580-378-06; 50580-378-07; 50580-378-08; 50580-378-37 | Defective Container | Kenvue Brands LLC / 3,816 bottles | Class II | Ongoing |
| D-0097-2026 | 10-21-2025 | Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squibb Company, Princeton, NJ 08543, NDC 0003-7125-11 Package NDCs: 0003-7125-11 | Lack of Assurance of Sterility. | Bristol-Myers Squibb Company / 12,778 total vials | Class II | Ongoing |
| D-0158-2026 | 10-20-2025 | NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals, Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274. Packaged by GSMS, Incorporated, Carmarillo, CA 93012. NDC: 51407-268-90 Package NDCs: 51407-267-90; 51407-268-90 | Failed Dissolution Specifications | Golden State Medical Supply Inc. / 24,869 bottles | Class II | Ongoing |
| D-0388-2026 | 10-20-2025 | SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China | Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam. | ANTHONY TRINH, 123Herbals LLC / N/A | Class I | Ongoing |
| D-0157-2026 | 10-20-2025 | Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bottle, Rx only, Mfg by: Imprimis NJOF, LLC, 1705 Route 46 West, Ledgewood, NJ 07852, NDC 71384-514-05 | Subpotent Drug | Imprimis NJOF, LLC / 67,091 bottles | Class III | Ongoing |
| D-0155-2026 | 10-17-2025 | Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for AERO HEALTHCARE US, Valley-Cottage, NY, 10989, NDC 55305-135-01 Package NDCs: 55305-135-01; 55305-135-02; 55305-135-03 | Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg. | Aero Healthcare / N/A | Class II | Ongoing |
| D-0103-2026 | 10-16-2025 | Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, carton NDC 60687-572-32, Individual unit dose: NDC 60687-572-33 Package NDCs: 60687-572-33; 60687-572-32 | Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit | Amerisource Health Services LLC / 3,410 cartons | Class II | Ongoing |
| D-0102-2026 | 10-16-2025 | Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-997-01, Individual unit dose: NDC 68084-997-11 Package NDCs: 68084-996-11; 68084-996-01; 68084-997-11; 68084-997-01 | Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit | Amerisource Health Services LLC / 1,818 cartons | Class II | Ongoing |
| D-0101-2026 | 10-16-2025 | Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-996-01. Individual unit dose: NDC 68084-996-11 Package NDCs: 68084-996-11; 68084-996-01; 68084-997-11; 68084-997-01 | Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit | Amerisource Health Services LLC / 1,970 cartons | Class II | Ongoing |
| D-0114-2026 | 10-15-2025 | Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09 | Lack of Assurance of Sterility | ProRx LLC / 2,809 vials | Class II | Ongoing |
| D-0115-2026 | 10-15-2025 | Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-04 | Lack of Assurance of Sterility | ProRx LLC / 8,400 vials | Class II | Ongoing |
| D-0116-2026 | 10-15-2025 | Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-08 | Lack of Assurance of Sterility | ProRx LLC / 8,310 vials | Class II | Ongoing |
| D-0119-2026 | 10-15-2025 | Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-02 | Lack of Assurance of Sterility | ProRx LLC / 2,805 vials | Class II | Ongoing |
| D-0120-2026 | 10-15-2025 | Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-209-03 | Lack of Assurance of Sterility | ProRx LLC / 2,761 vials | Class II | Ongoing |
