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-0117-2026 | 10-15-2025 | Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL 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 / 11,119 vials | Class II | Ongoing |
| D-0118-2026 | 10-15-2025 | Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-06 | Lack of Assurance of Sterility | ProRx LLC / 2,649 vials | Class II | Ongoing |
| D-0124-2026 | 10-14-2025 | Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0387-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 829 pellets | Class II | Ongoing |
| D-0125-2026 | 10-14-2025 | Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0383-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 829 pellets | Class II | Ongoing |
| D-0123-2026 | 10-14-2025 | Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0389-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 1,329pellets | Class II | Ongoing |
| D-0133-2026 | 10-14-2025 | Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0365-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 64,924 pellets | Class II | Ongoing |
| D-0130-2026 | 10-14-2025 | Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0363-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 18,124 pellets | Class II | Ongoing |
| D-0135-2026 | 10-14-2025 | Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0382-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 21,324 pellets | Class II | Ongoing |
| D-0129-2026 | 10-14-2025 | Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0402-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 14,329 pellets | Class II | Ongoing |
| D-0136-2026 | 10-14-2025 | Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0367-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 103,444 pellets | Class II | Ongoing |
| D-0127-2026 | 10-14-2025 | Testosterone 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0381-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 4,929 pellets | Class II | Ongoing |
| D-0128-2026 | 10-14-2025 | Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0401-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 4,829 pellets | Class II | Ongoing |
| D-0134-2026 | 10-14-2025 | Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0366-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 31,124 pellets | Class II | Ongoing |
| D-0126-2026 | 10-14-2025 | Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0386-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 529 pellets | Class II | Ongoing |
| D-0132-2026 | 10-14-2025 | Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0380-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 43,424 Pellets | Class II | Ongoing |
| D-0137-2026 | 10-14-2025 | Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0364-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 264,664 pellets | Class II | Ongoing |
| D-0131-2026 | 10-14-2025 | Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0379-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 36,924 pellets | Class II | Ongoing |
| D-0151-2026 | 10-13-2025 | Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-2277-7. | Subpotent drug; Clavulanate Potassium component | Teva Pharmaceuticals USA, Inc / 4680 cartons | Class II | Ongoing |
| D-0214-2026 | 10-10-2025 | Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26605. NDC: 67457-426-12 with Safecor Health LLC KITCHECK RFID Tag attached with incorrect serial numbers: KITCHECK 8001-03A3,00000000,003A-2560, and 8001-03A3,00000000,003A-2D3B. Package NDCs: 67457-426-00; 67457-426-12 | Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm. | Safecor Health, LLC / 800 1mL vials | Class II | Ongoing |
| D-0096-2026 | 10-10-2025 | Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 62175-322-46 Package NDCs: 62175-320-46; 62175-320-43; 62175-322-46; 62175-322-43 | Failed Dissolution Specifications | Lannett Company Inc. / 46,848 90-count bottles | Class II | Ongoing |
| D-0142-2026 | 10-10-2025 | Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-119-91 | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Endo USA, Inc. / 2,035 cartons | Class III | Ongoing |
| D-0140-2026 | 10-10-2025 | Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91 | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Endo USA, Inc. / 1,866 cartons | Class III | Ongoing |
| D-0156-2026 | 10-10-2025 | Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30 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; 2405006633 | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. | Alembic Pharmaceuticals Limited / 4,884 30-count bottles | Class III | Ongoing |
| D-0193-2026 | 10-10-2025 | Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-048-17, UPC 8 10145 82007 0 | CGMP Deviations | CA BOTANA International, Inc. / 3295 bottles | Class II | Ongoing |
| D-0190-2026 | 10-10-2025 | Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist. By: Gabriel Cosmetics, Inc., Redmond, WA USA 98052, NDC: 35192-044-01, UPC 7 07060 9592 1 | CGMP Deviations | CA BOTANA International, Inc. / 1617 tubes | Class II | Ongoing |
| D-0113-2026 | 10-10-2025 | R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. INJECTION FOR PERIARTICULAR USE; Not for IV Use. THIS IS A COMPOUNDED DRUG. QuVA Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, TX 77478. NDC 70092-1433-50 | Presence of Particulate Matter | QuVa Pharma, Inc. / 75,885 syringes | Class II | Ongoing |
| D-0194-2026 | 10-10-2025 | Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-050-17, UPC 6 7229 99913 8 | CGMP Deviations | CA BOTANA International, Inc. / N/A | Class II | Ongoing |
| D-0196-2026 | 10-10-2025 | Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC, Palm Desert, CA 92211. NDC: 35192-052-18, UPC 8 18204 02513 8 | CGMP Deviations | CA BOTANA International, Inc. / 4890 bottles | Class II | Ongoing |
| D-0186-2026 | 10-10-2025 | Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-017-05 | CGMP Deviations | CA BOTANA International, Inc. / 470 tubes | Class II | Ongoing |
| D-0139-2026 | 10-10-2025 | Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-125-91 | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Endo USA, Inc. / 6,655 cartons | Class III | Ongoing |
| D-0099-2026 | 10-10-2025 | HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured by: SAMSUN BIOEPIS Co., Ltd, Incheon, Republic of Korea, NDC 78206-183-01. | Lack of Assurance of Sterility. | Samsung Bioepis Co., Ltd. / 5,518 packs (11,036 Syringes) 2 syringes/carton) | Class II | Ongoing |
| D-0187-2026 | 10-10-2025 | Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-011-02 | CGMP Deviations | CA BOTANA International, Inc. / 874 tubes | Class II | Ongoing |
| D-0188-2026 | 10-10-2025 | Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica, Menthol 5%, 4.2 oz./120 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-020-02 | CGMP Deviations | CA BOTANA International, Inc. / 810 tubes | Class II | Ongoing |
| D-0185-2026 | 10-10-2025 | Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-016-05 | CGMP Deviations | CA BOTANA International, Inc. / 555 tubes | Class II | Ongoing |
| D-0195-2026 | 10-10-2025 | CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC: 35192-046-17 | CGMP Deviations | CA BOTANA International, Inc. / 4890 bottles | Class II | Ongoing |
| D-0189-2026 | 10-10-2025 | Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% and Octinoxate 4%, 4 oz./113.4 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-012-02 | CGMP Deviations | CA BOTANA International, Inc. / 805 tubes | Class II | Ongoing |
| D-0183-2026 | 10-10-2025 | Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA 92123. NDC: 35192-042-02 | CGMP Deviations | CA BOTANA International, Inc. / 1167 tubes | Class II | Ongoing |
| D-0191-2026 | 10-10-2025 | Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT. 5 oz/ 141.7 g per tube, Dist. By: Beauty4Pros LLC, Palm Desert, CA 92211. NDC: 35192-033-16, UPC 8 18204 02572 5 | CGMP Deviations | CA BOTANA International, Inc. / 1492 tubes | Class II | Ongoing |
| D-0184-2026 | 10-10-2025 | Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21%, 2.1 oz/61 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-043-17 | CGMP Deviations | CA BOTANA International, Inc. / 1401 tubes | Class II | Ongoing |
| D-0192-2026 | 10-10-2025 | Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 OZ (93 G) per tube, Dist. By: Sugared+Bronzed, 929 Montana Ave, Santa Monica, CA 90403. NDC: 35192-055-18, UPC 8 50047 92223 6 | CGMP Deviations | CA BOTANA International, Inc. / 2090 tubes | Class II | Ongoing |
| D-0141-2026 | 10-10-2025 | Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-128-91 | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Endo USA, Inc. / 935 cartons | Class III | Ongoing |
| D-0031-2026 | 10-10-2025 | Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag). Package NDCs: 55154-3363-0; 55154-7992-0; 55154-7993-0; 0904-6665-61 | Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . | The Harvard Drug Group LLC / | Class II | Ongoing |
| D-0030-2026 | 10-10-2025 | Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 | Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . | The Harvard Drug Group LLC / | Class II | Ongoing |
| D-0098-2026 | 10-09-2025 | Taoscare Motion Sickness Patches 36-count box, Henan Xinyongtal Medical Technology., Ltd., Address: he nan sheng zhou kou shi huai yang xian gong ye yuan qu, X003SR097N | Marketed Without an Approved NDA/ANDA | ibspot / 3 boxes | Class II | Ongoing |
| D-0025-2026 | 10-09-2025 | FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0102-05. | Labeling: Incorrect or Missing Lot and/or Exp Date | STAQ Pharma, Inc. / | Class III | Ongoing |
| D-0027-2026 | 10-09-2025 | Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose] | CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated. | Amerisource Health Services LLC / 27,868 blister packs | Class II | Ongoing |
| D-0100-2026 | 10-09-2025 | Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922. 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: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm. | Breckenridge Pharmaceutical, Inc. / 172,263 bottles | Class II | Ongoing |
| D-0034-2026 | 10-09-2025 | Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rouge, LA 70810, NDC 70512-0520-05 | Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit. | USV Private Limited / 8,952 bottles | Class II | Ongoing |
| D-0024-2026 | 10-09-2025 | Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02. | Labeling: Incorrect or Missing Lot and/or Exp Date | STAQ Pharma, Inc. / | Class III | Ongoing |
| D-0023-2026 | 10-09-2025 | Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0104-05. | Labeling: Incorrect or Missing Lot and/or Exp Date | STAQ Pharma, Inc. / | Class III | Ongoing |
| D-0396-2026 | 10-08-2025 | Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distributed by: Max Nutrition Inc. UPC 6 78945 36675 0 | Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule). | Mohamed Hagar / 125 boxes | Class I | Ongoing |
| D-0028-2026 | 10-08-2025 | Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden, Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. NDC 0310-1730-30 Package NDCs: 0310-1730-30; 0310-1730-85; 0310-1830-30; 0310-1830-85; 0310-1745-01; 0310-1745-95 | Lack of Assurance of Sterility: | ASTRAZENECA PHARMACEUTICALS / 916 pre-filled syringes | Class II | Ongoing |
| D-0029-2026 | 10-07-2025 | Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ, 08816, Manufactured by Suven Pharmaceuticals Limited, Pashamylaram, Telangana, 205307, India. NDC# 16571-691-01 Package NDCs: 16571-689-01; 16571-690-01; 16571-691-01; 16571-692-01; 16571-693-01; 16571-694-01 | Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg). | Rising Pharma Holding, Inc. / 2,064 100-count bottles | Class II | Ongoing |
| D-0104-2026 | 10-07-2025 | Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4067-01, b) 1000 Capsules, NDC 0093-4067-10 Package NDCs: 0093-4067-01; 0093-4067-10; 0093-4068-01; 0093-4068-10; 0093-4069-01; 0093-4069-52; 0093-4069-05 | CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots. | Teva Pharmaceuticals USA, Inc / 181,659 bottles | Class II | Ongoing |
| D-0106-2026 | 10-07-2025 | Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4069-01, b) 250 Capsules, NDC 0093-4069-52, c) 500 Capsules, NDC 0093-4069-05 Package NDCs: 0093-4067-01; 0093-4067-10; 0093-4068-01; 0093-4068-10; 0093-4069-01; 0093-4069-52; 0093-4069-05 | CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots. | Teva Pharmaceuticals USA, Inc / 107,673 | Class II | Ongoing |
| D-0105-2026 | 10-07-2025 | Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10 Package NDCs: 0093-4067-01; 0093-4067-10; 0093-4068-01; 0093-4068-10; 0093-4069-01; 0093-4069-52; 0093-4069-05 | CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots. | Teva Pharmaceuticals USA, Inc / 291,512 bottles | Class II | Ongoing |
| D-0109-2026 | 10-06-2025 | Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. Package NDCs: 23155-578-01; 23155-579-01; 23155-580-01; 23155-581-01; 23155-582-01; 23155-583-25 | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. | Heritage Pharmaceuticals Inc / 5880 bottles. | Class II | Ongoing |
| D-0110-2026 | 10-06-2025 | Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. Package NDCs: 23155-578-01; 23155-579-01; 23155-580-01; 23155-581-01; 23155-582-01; 23155-583-25 | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. | Heritage Pharmaceuticals Inc / 2,418 bottles. | Class II | Ongoing |
| D-0016-2026 | 10-06-2025 | Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-102-04. Package NDCs: 72578-102-04 | Discoloration | VIONA PHARMACEUTICALS INC / 13080 bottles | Class II | Ongoing |
| D-0112-2026 | 10-06-2025 | Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. Package NDCs: 23155-578-01; 23155-579-01; 23155-580-01; 23155-581-01; 23155-582-01; 23155-583-25 | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. | Heritage Pharmaceuticals Inc / 3,750 bottles. | Class II | Ongoing |
| D-0107-2026 | 10-06-2025 | Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. Package NDCs: 23155-578-01; 23155-579-01; 23155-580-01; 23155-581-01; 23155-582-01; 23155-583-25 | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. | Heritage Pharmaceuticals Inc / 6,979 bottles. | Class II | Ongoing |
| D-0111-2026 | 10-06-2025 | Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. Package NDCs: 23155-578-01; 23155-579-01; 23155-580-01; 23155-581-01; 23155-582-01; 23155-583-25 | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. | Heritage Pharmaceuticals Inc / 5,882 bottles. | Class II | Ongoing |
| D-0108-2026 | 10-06-2025 | Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. Package NDCs: 23155-578-01; 23155-579-01; 23155-580-01; 23155-581-01; 23155-582-01; 23155-583-25 | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. | Heritage Pharmaceuticals Inc / 8,754 bottles. | Class II | Ongoing |
| D-0258-2026 | 10-03-2025 | 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. | Advanced Pharmaceutical Technology, Inc. / 22,843 pellets | Class II | Ongoing |
| D-0095-2026 | 10-01-2025 | ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628, NDC 10237-469-25 Package NDCs: 10237-469-25; 10237-469-22 | Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient. | Church & Dwight Co., Inc. / 21,912 bottles | Class II | Ongoing |
| D-0036-2026 | 10-01-2025 | Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Telangana - 502281, INDIA., U.S. Contact Number: 1-866-495-1995, NDC 31722-307-25 (Carton), 31722-307-02 (Vial label). Package NDCs: 31722-305-25; 31722-305-10; 31722-306-25; 31722-307-25; 31722-307-02 | Presence of Particulate Matter: Particulate matter identified as glass | Aspiro Pharma Limited / | Class II | Ongoing |
| D-0005-2026 | 09-29-2025 | AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersburg, PA 17201, Toll Free: 800-345-1329, Package Configuration: a) 4x1 Gallon Case, 5 Gallon Pail, 55 Gallon Drum. | cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded. | Acuity Specialty Products, Inc. / | Class II | Ongoing |
| D-0004-2026 | 09-29-2025 | Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Development Avenue, Chambersburg, PA 17210, Toll Free: 800-345-1329, Package Configurations: a) 6x1000mL Case, b) 4x1 Gallon Case, c) 5 Gallon Pail, d) 55 Gallon Drum. | cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded. | Acuity Specialty Products, Inc. / | Class II | Ongoing |
| D-0035-2026 | 09-29-2025 | Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL, 60093 USA, NDC 55329-811-30. | Subpotent Drug | Medline Industries, LP / 222,800 eaches | Class II | Ongoing |
| D-0014-2026 | 09-29-2025 | Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05. Package NDCs: 42192-501-50; 42192-501-05 | Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications. | Acella Pharmaceuticals, LLC / 4,680 500-count bottles | Class II | Ongoing |
| D-0008-2026 | 09-26-2025 | Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Intramuscular use, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540. NDC: 43598-666-25 Package NDCs: 43598-666-11; 43598-666-25 | Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration. | Dr. Reddy's Laboratories, Inc. / 571 vials | Class II | Ongoing |
| D-0022-2026 | 09-25-2025 | Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 112, Eden Prairie, Minnesota 55344 | cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing. | SV Labs Prescott Corporation / 11,386 tubes | Class II | Ongoing |
| D-0002-2026 | 09-24-2025 | Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06. Package NDCs: 68382-920-06; 68382-920-16; 68382-920-01; 68382-920-30; 68382-920-77; 68382-921-06; 68382-921-16; 68382-921-01; 68382-921-30; 68382-921-77 | Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity | Zydus Pharmaceuticals (USA) Inc / 600 30-count bottles | Class II | Ongoing |
| D-0001-2026 | 09-24-2025 | Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06. Package NDCs: 68382-920-06; 68382-920-16; 68382-920-01; 68382-920-30; 68382-920-77; 68382-921-06; 68382-921-16; 68382-921-01; 68382-921-30; 68382-921-77 | Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity | Zydus Pharmaceuticals (USA) Inc / 912 30-count bottles | Class II | Ongoing |
| D-0178-2026 | 09-23-2025 | Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1. | CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results. | Park Avenue Compounding / 189 bags | Class II | Ongoing |
| D-0122-2026 | 09-23-2025 | Sting Relief Swabs, First Aid Only, 10 Swabs per box, part number 19-001, Manufactured for: Acme United Corporation, 1 Waterview Dr. Shelton, CT, Made in the USA UPC 738743190015 | Product Mix-up | ACME UNITED CORPORATION / 2338 boxes | Class II | Ongoing |
| D-0003-2026 | 09-22-2025 | Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436. | Lack of assurance of sterility. | RC Outsourcing, LLC / 2,669 syringes | Class II | Terminated |
| D-0020-2026 | 09-19-2025 | Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054 Package NDCs: 67877-511-90; 67877-511-05; 67877-511-10; 67877-511-55; 67877-511-33; 67877-511-38; 67877-512-90; 67877-512-05; 67877-512-10; 67877-512-44; 67877-512-33; 67877-512-38; 67877-513-90; 67877-513-05; 67877-513-10; 67877-513-23; 67877-513-33; 67877-513-38; 67877-514-90; 67877-514-05; 67877-514-10; 67877-514-33; 67877-514-38 | Failed Dissolution Specifications | Ascend Laboratories, LLC / | Class II | Ongoing |
| D-0017-2026 | 09-19-2025 | Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. Package NDCs: 67877-511-90; 67877-511-05; 67877-511-10; 67877-511-55; 67877-511-33; 67877-511-38; 67877-512-90; 67877-512-05; 67877-512-10; 67877-512-44; 67877-512-33; 67877-512-38; 67877-513-90; 67877-513-05; 67877-513-10; 67877-513-23; 67877-513-33; 67877-513-38; 67877-514-90; 67877-514-05; 67877-514-10; 67877-514-33; 67877-514-38 | Failed Dissolution Specifications | Ascend Laboratories, LLC / 141,984 bottles | Class II | Ongoing |
| D-0018-2026 | 09-19-2025 | Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. Package NDCs: 67877-511-90; 67877-511-05; 67877-511-10; 67877-511-55; 67877-511-33; 67877-511-38; 67877-512-90; 67877-512-05; 67877-512-10; 67877-512-44; 67877-512-33; 67877-512-38; 67877-513-90; 67877-513-05; 67877-513-10; 67877-513-23; 67877-513-33; 67877-513-38; 67877-514-90; 67877-514-05; 67877-514-10; 67877-514-33; 67877-514-38 | Failed Dissolution Specifications | Ascend Laboratories, LLC / | Class II | Ongoing |
| D-0019-2026 | 09-19-2025 | Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. Package NDCs: 67877-511-90; 67877-511-05; 67877-511-10; 67877-511-55; 67877-511-33; 67877-511-38; 67877-512-90; 67877-512-05; 67877-512-10; 67877-512-44; 67877-512-33; 67877-512-38; 67877-513-90; 67877-513-05; 67877-513-10; 67877-513-23; 67877-513-33; 67877-513-38; 67877-514-90; 67877-514-05; 67877-514-10; 67877-514-33; 67877-514-38 | Failed Dissolution Specifications | Ascend Laboratories, LLC / | Class II | Ongoing |
| D-0662-2025 | 09-17-2025 | Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52 Package NDCs: 68462-626-52 | CGMP Deviations: Market complaints received for gritty texture (grainy) | Glenmark Pharmaceuticals Inc., USA / 13824 tubes | Class II | Ongoing |
| D-0200-2026 | 09-17-2025 | Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 83863-0104-1. | CGMP Deviations | Park Avenue Compounding / 858 syringes | Class II | Ongoing |
| D-0015-2026 | 09-16-2025 | Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota Ave Se, Minneapolis, MN 55414-2842 NDC 71139-0012-1 | Subpotent Drug: Testing revealed there was no oxytocin in the IV bag. | IntegraDose Compounding Services LLC / 853/500 mL bags | Class I | Ongoing |
| D-0006-2026 | 09-16-2025 | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15. Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range. | ACCORD HEALTHCARE, INC. / 54,432 bottles | Class II | Ongoing |
| D-0675-2025 | 09-15-2025 | Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11) Package NDCs: 60687-583-11; 60687-583-21; 60687-594-11; 60687-594-21 | Failed Dissolution Specifications. | Amerisource Health Services LLC / 360 cartons | Class II | Ongoing |
| D-0037-2026 | 09-15-2025 | Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03. Package NDCs: 16571-862-03; 16571-862-09; 16571-862-50; 16571-862-10; 16571-862-12; 16571-863-03; 16571-863-09; 16571-863-50; 16571-863-10 | Failed Tablet/Capsule Specifications | Graviti Pharmaceuticals Private Limited / 46,512/30 count bottles | Class II | Ongoing |
| D-0138-2026 | 09-12-2025 | Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604 | Labeling: Not Elsewhere Classified | Letco Medical LLC / 173 500 ml bottles | Class III | Ongoing |
| D-0033-2026 | 09-12-2025 | Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-50 Package NDCs: 16571-402-10; 16571-402-30; 16571-402-50 | Tablet/Capsules Imprinted with Wrong ID | JB Chemicals and Pharmaceuticals Ltd / 13,440 bottles | Class III | Ongoing |
| D-0032-2026 | 09-12-2025 | Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-10. Package NDCs: 16571-402-10; 16571-402-30; 16571-402-50 | Tablet/Capsules Imprinted with Wrong ID | JB Chemicals and Pharmaceuticals Ltd / 9936 bottles | Class III | Ongoing |
| D-0013-2026 | 09-12-2025 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61, UPC (01)00309047133611 NDC 0904-7133-61 | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 1394 blister packs | Class II | Ongoing |
| D-0010-2026 | 09-12-2025 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-61, UPC (01)00309047130610 | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 1256 blister packs | Class II | Ongoing |
| D-0009-2026 | 09-12-2025 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UPC (01)00309047130061 | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 2064 blister packs | Class II | Ongoing |
| D-0012-2026 | 09-12-2025 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7132-61, UPC (01)00309047132614 | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 866 blister packs | Class II | Ongoing |
| D-0011-2026 | 09-12-2025 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61, UPC (01)00309047131617 | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 506 blister packs | Class II | Ongoing |
| D-0666-2025 | 09-12-2025 | mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, 201 g Mel Skin Rx Beverly Hills, CA 90210 | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. | Private Label Skin Care Inc. / N/A | Class II | Ongoing |
| D-0664-2025 | 09-12-2025 | Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7 oz (201 g), Monika Kiripolsky, MD Beverly Hills, CA, 90211 | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. | Private Label Skin Care Inc. / N/A | Class II | Ongoing |
| D-0663-2025 | 09-12-2025 | ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz (201 g), Artisan of Skin Beverly Hills, CA 90210 | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. | Private Label Skin Care Inc. / 125 | Class II | Ongoing |
| D-0665-2025 | 09-12-2025 | Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl Peroxide 10%) 7oz (201 g), Torreypines.com | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. | Private Label Skin Care Inc. / N/A | Class II | Ongoing |
| D-0668-2025 | 09-12-2025 | edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) Uptown Medi Spa, Phoenix, AZ. | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. | Private Label Skin Care Inc. / N/A | Class II | Ongoing |
