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 August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0375-2026 | 01-20-2026 | Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-01 Package NDCs: 67777-245-01; 67777-245-11; 67777-245-02; 67777-245-14; 67777-245-04; 67777-245-15; 67777-245-05; 67777-245-06; 67777-245-16; 67777-245-08; 67777-245-18; 67777-245-07; 67777-245-17 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0363-2026 | 01-20-2026 | Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towelette, 4x7, Max Packaging, Made in the USA, NDC 59647-750-01 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0358-2026 | 01-20-2026 | First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes, NDC 0924-7116-04 Package NDCs: 0924-7116-00; 0924-7116-04; 0924-7116-05; 0924-7116-03; 0924-7116-01; 0924-7116-02 | CGMP Deviations | ACME UNITED CORPORATION / 212,607,900 containers | Class II | Ongoing |
| D-0370-2026 | 01-20-2026 | Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0243-00. Package NDCs: 0924-0243-00; 0924-0243-01 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0376-2026 | 01-20-2026 | Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-04. Package NDCs: 67777-245-01; 67777-245-11; 67777-245-02; 67777-245-14; 67777-245-04; 67777-245-15; 67777-245-05; 67777-245-06; 67777-245-16; 67777-245-08; 67777-245-18; 67777-245-07; 67777-245-17 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0378-2026 | 01-20-2026 | Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Custom Packaging Co., Inc, Louisville, KY 4023, NDC 0924-251-00. | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0377-2026 | 01-20-2026 | Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chloride 0.13%), 1000 per case, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0366-2026 | 01-20-2026 | Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr, Shelton, CT 06481, NDC 0924-0246-01. Package NDCs: 0924-0246-00; 0924-0246-01; 0924-0246-02; 0924-0246-03 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0369-2026 | 01-20-2026 | Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA Made in USA, NDC 67777-244-02 Package NDCs: 67777-244-02; 67777-244-01 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0368-2026 | 01-20-2026 | Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.13%), Manufactured for: CFS Brands DBA WipesPlus, 4711 E. Heiner Rd. Oklahoma City, OK 73331, NDC 67151-333-01. | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| D-0364-2026 | 01-20-2026 | Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 towelette, 4 x 7, R&R Enterprise, NDC 59647-749-02 | CGMP Deviations | ACME UNITED CORPORATION / N/A | Class II | Ongoing |
| 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-0353-2026 | 01-16-2026 | UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63 Package NDCs: 69448-025-63; 69448-026-63; 69448-027-63 | Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment. | McKesson / 116 cartons | Class I | Ongoing |
| D-0299-2026 | 01-15-2026 | methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977. NDC 59762-4440-2 Package NDCs: 59762-4440-3; 59762-4440-2; 59762-0049-1; 59762-0050-1; 59762-0051-1 | Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil. | Greenstone Llc / 3456 cartons | Class II | Ongoing |
| D-0338-2026 | 01-14-2026 | Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this package is from NDC # 10702-018, KVK-Tech Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-354-01; Blister NDC 68084-354-11 Package NDCs: 68084-354-11; 68084-354-01; 68084-968-11; 68084-968-01; 68084-975-11; 68084-975-01; 68084-983-11; 68084-983-01 | Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities. | Amerisource Health Services LLC / 31,676 packages | Class II | Ongoing |
| D-0445-2026 | 01-12-2026 | Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435-15 (carton), NDC 0591-2435-45 (blister pack). Package NDCs: 0591-2433-45; 0591-2433-15; 0591-2434-45; 0591-2434-15; 0591-2451-45; 0591-2451-15; 0591-2435-45; 0591-2435-15; 0591-2501-45; 0591-2501-15; 0591-2436-45; 0591-2436-15 | Superpotent and Subpotent | Teva Pharmaceuticals USA, Inc / 21984 packages | Class II | Ongoing |
| D-0446-2026 | 01-12-2026 | Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack). Package NDCs: 0591-2433-45; 0591-2433-15; 0591-2434-45; 0591-2434-15; 0591-2451-45; 0591-2451-15; 0591-2435-45; 0591-2435-15; 0591-2501-45; 0591-2501-15; 0591-2436-45; 0591-2436-15 | Superpotent and Subpotent | Teva Pharmaceuticals USA, Inc / 8376 packages | 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-0348-2026 | 12-31-2025 | Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa PVT. LTD., H-881, Phase 3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ 85260, NDC 77790-003-10. Package NDCs: 77790-003-10 | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. | Wizcure Pharmaa Private Limited / 11,520 cartons | Class II | Ongoing |
| D-0346-2026 | 12-31-2025 | Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10. | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. | Wizcure Pharmaa Private Limited / 5,760 cartons | Class II | Ongoing |
| D-0347-2026 | 12-31-2025 | Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-002-10. Package NDCs: 77790-002-10 | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. | Wizcure Pharmaa Private Limited / 17,280 cartons | Class II | Ongoing |
| D-0350-2026 | 12-31-2025 | CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India, Package NDCs: 83851-100-10; 83851-100-30; 83851-100-05 | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. | Wizcure Pharmaa Private Limited / 10,080 boxes | Class II | Ongoing |
| D-0352-2026 | 12-31-2025 | BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:[email protected], Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11. | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. | Wizcure Pharmaa Private Limited / 184,320 containers | Class II | Ongoing |
| D-0349-2026 | 12-31-2025 | Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15. Package NDCs: 77790-022-15 | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. | Wizcure Pharmaa Private Limited / 139,104 cartons | Class II | Ongoing |
| D-0351-2026 | 12-31-2025 | Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:[email protected], Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30. | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. | Wizcure Pharmaa Private Limited / 50,400 Boxes | 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 to oxidation caused by leakage of the contents of the capsules | Zydus Pharmaceuticals (USA) Inc / 22,896 bottles | Class II | 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-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-0524-2026 | 12-27-2025 | TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90670 | Incorrect Product Formulation: product did not contain insulin as listed in the label. | Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles / 1 bag | 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-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-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-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-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-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-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-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-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-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-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-0297-2026 | 12-26-2025 | parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by Haleon, Warren, NJ 07059. NDC 0135-0651-02 Package NDCs: 0135-0651-02; 0135-0651-03; 0135-0650-01 | Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles. | Haleon US Holdings LLC / 84,764 bottles | Class III | 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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. 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-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 |
