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-0652-2026 | 06-11-2026 | BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-34, catalog number 930700NS. Package NDCs: 54365-400-34 | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel | CareFusion 213, LLC / 100 units | Class II | Ongoing |
| D-0663-2026 | 06-11-2026 | Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 80090 2 FL OZ (59 mL) NDC 53329-159-13 4 FL OZ (118 mL) NDC 53329-159-04 | Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification. | BioMed Laboratories, LLC. / 509,652 tubes | Class II | Ongoing |
| D-0650-2026 | 06-11-2026 | BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 25 x 26 mL applicators/case, NDC 54365-400-39, catalog number 930825NS, b) 50 x 26 mL applicators/case, NDC 54365-400-39, bulk catalog number 930825NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. Package NDCs: 54365-400-39 | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel | CareFusion 213, LLC / 125 units | Class II | Ongoing |
| D-0651-2026 | 06-11-2026 | BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31, bulk catalog number 930480NSB Package NDCs: 54365-400-31 | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel | CareFusion 213, LLC / 18,000 units | Class II | Ongoing |
| D-0648-2026 | 06-11-2026 | BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as: a) 25 x 26 mL applicators/case, NDC 54365-400-38, calatog number 930815NS: b) 50 x 26 mL appliactors/case, bulk catalog number 930815NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. Package NDCs: 54365-400-38 | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel | CareFusion 213, LLC / 400 units | Class II | Ongoing |
| D-0645-2026 | 06-11-2026 | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b) 250 x 3ml applicators/case, NDC 54365-400-32, bulk Catalog 930500NSB, Sterile Solution, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. Package NDCs: 54365-400-32 | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel | CareFusion 213, LLC / 146,600 units | Class II | Ongoing |
| D-0647-2026 | 06-11-2026 | BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 3 mL applicators/case, NDC 54365-400-33, calatog 930415NS: b) 250 x 3mL applicators/case, bulk catalog number 930415NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. Package NDCs: 54365-400-33 | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel | CareFusion 213, LLC / 7,650 units | Class II | Ongoing |
| D-0646-2026 | 06-11-2026 | ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-30, Catalog number 930599NSB Package NDCs: 54365-400-30 | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel | CareFusion 213, LLC / 10,500 units | Class II | Ongoing |
| D-0643-2026 | 06-11-2026 | BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applicators/case, Catalog Number bulk 930715NSB, NDC 54365-400-35; STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co. Package NDCs: 54365-400-35 | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel | CareFusion 213, LLC / 1,800 units | Class II | Ongoing |
| D-0644-2026 | 06-11-2026 | BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co, Catalog Number 960120NSB; NDC 54365-014-42. Package NDCs: 54365-014-42; 54365-014-41 | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel | CareFusion 213, LLC / N/A | Class II | Ongoing |
| D-0649-2026 | 06-11-2026 | BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5 mL Applicators/case, NDC 54365-400-36, catalog number 930725NS; b) 100 x 10.5 mL Applicators/case, bulk catalog number 930725NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. Package NDCs: 54365-400-36 | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel | CareFusion 213, LLC / 1,200 units | Class II | Ongoing |
| D-0653-2026 | 06-10-2026 | IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA, Manufactured at: Catalent Indiana, LLC, 1300 S. Patterson Drive, Bloomington, IN 47403, USA, NDC 69448-019-26. Package NDCs: 69448-018-63; 69448-017-63; 69448-019-26 | Lack of assurance of Sterility: | ACCORD BIOPHARMA INC / 326 vials | Class II | Ongoing |
| D-0714-2026 | 06-10-2026 | Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany; Distributed by: Hikma, Berkeley Heights, NJ 07922. NDC: 0143-9341-01 Package NDCs: 0143-9340-01; 0143-9341-01; 0143-9342-01 | Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment. | McKesson / 74 units | Class II | Ongoing |
| D-0656-2026 | 06-08-2026 | Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: lntas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-458-15. 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 Drug | ACCORD HEALTHCARE, INC. / 6432 bottles | Class II | Ongoing |
| D-0658-2026 | 06-08-2026 | Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-715-01. Package NDCs: 76420-715-01 | Lack of Assurance of Sterility | Asclemed USA Inc. / N/A | Class II | Ongoing |
| D-0659-2026 | 06-08-2026 | Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 85766-187-01. Package NDCs: 85766-187-01; 85766-187-25 | Lack of Assurance of Sterility | Asclemed USA Inc. / N/A | Class II | Ongoing |
| D-0662-2026 | 06-07-2026 | Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-893-31 Package NDCs: 23155-893-31 | Failed Impurities/Degradation Specifications | ONESOURCE SPECIALTY PHARMA LIMITED / 4284 vials | Class II | Ongoing |
| D-0610-2026 | 06-05-2026 | Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA. Distributed by: Risiong Pharma Holdings, Inc., East Brunswick, NJ 08816. NDC 100-tablet bottle: 64980-599-01; NDC 1000-tablet bottle: 64980-599-10 Package NDCs: 64980-599-01; 64980-599-10; 64980-600-01 | Failed Dissolution Specifications | Inventia Healthcare Limited / 11,460 bottles | Class II | Ongoing |
| D-0627-2026 | 06-04-2026 | Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, NDC 57511-0611-1. Package NDCs: 57511-0611-1 | sub potency | Elevate Oral Care / 8132 6-packs & 2262 2-packs | Class II | Ongoing |
| D-0595-2026 | 06-04-2026 | Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059. | Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process. | Haleon US Holdings LLC / 35,883 boxes/carton | Class I | Ongoing |
| D-0616-2026 | 06-04-2026 | Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. NDC 55513-075-30 Package NDCs: 55513-073-30; 55513-074-30; 55513-075-30 | CGMP Deviations | Amgen, Inc. / N/A | Class II | Ongoing |
| D-0583-2026 | 06-04-2026 | Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, 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: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Breckenridge Pharmaceutical, Inc. / 359,676 bottles | Class II | Ongoing |
| D-0614-2026 | 06-04-2026 | Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30 Package NDCs: 55513-073-30; 55513-074-30; 55513-075-30 | CGMP Deviations | Amgen, Inc. / N/A | Class II | Ongoing |
| D-0613-2026 | 06-04-2026 | Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30 Package NDCs: 55513-073-30; 55513-074-30; 55513-075-30 | CGMP Deviations | Amgen, Inc. / 9565 bottles | Class II | Ongoing |
| D-0582-2026 | 06-04-2026 | Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10 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 FDA recommended interim limit | Breckenridge Pharmaceutical, Inc. / 14,729 bottles. | Class II | Ongoing |
| D-0655-2026 | 06-04-2026 | prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: Lupin Limited, Pithampur (M.P) 454 775, INDIA Package NDCs: 70748-332-03; 70748-332-02; 70748-332-04 | Presence of Foreign Substance | Lupin Pharmaceuticals Inc. / 2,530,182 bottles | Class II | Ongoing |
| D-0626-2026 | 06-04-2026 | Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-813-60. Package NDCs: 31722-812-60; 31722-812-18; 31722-812-05; 31722-812-32; 31722-813-60; 31722-813-18; 31722-813-05; 31722-813-32; 31722-814-60; 31722-814-18; 31722-814-05; 31722-814-32; 31722-815-60; 31722-815-18; 31722-815-05; 31722-815-32 | Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg. | Annora Pharma Private Limited / 31,392 60-count bottles | Class II | Ongoing |
| D-0612-2026 | 06-04-2026 | Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. Package NDCs: 55513-800-60; 55513-800-99; 55513-810-60; 55513-813-01; 55513-813-28 | Presence of Foreign Substance. | Amgen, Inc. / 934577 bottles | Class II | Ongoing |
| D-0615-2026 | 06-04-2026 | Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60 Package NDCs: 55513-800-60; 55513-800-99; 55513-810-60; 55513-813-01; 55513-813-28 | Presence of Foreign Substance. | Amgen, Inc. / N/A | Class II | Ongoing |
| D-0585-2026 | 06-03-2026 | Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01 Package NDCs: 53746-544-01; 53746-544-10; 53746-544-05; 53746-545-01; 53746-545-10; 53746-545-05 | Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer. | Amneal Pharmaceuticals, LLC / 27,936 100-count bottles | Class III | Ongoing |
| D-0631-2026 | 06-02-2026 | Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g) tubes, Product manufactured for Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC 1 94283 65181 0. | CGMP Deviations; deficiencies observed during FDA inspection | Dabur India Limited / 2420 tubes | Class II | Ongoing |
| D-0634-2026 | 06-02-2026 | Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 52924 00683 1. | CGMP Deviations; deficiencies observed during FDA inspection | Dabur India Limited / 84 tubes | Class II | Ongoing |
| D-0619-2026 | 06-02-2026 | hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10 Package NDCs: 70954-912-10 | Presence of foreign substance | ANI Pharmaceuticals, Inc. / 6564 bottles | Class III | Ongoing |
| D-0639-2026 | 06-02-2026 | Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 305061. | CGMP Deviations; deficiencies observed during FDA inspection | Dabur India Limited / 4,738 tubes | Class II | Ongoing |
| D-0638-2026 | 06-02-2026 | Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 524103 0244 2. | CGMP Deviations; deficiencies observed during FDA inspection | Dabur India Limited / 5755 tubes | Class II | Ongoing |
| D-0642-2026 | 06-02-2026 | Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 5 mg, Polymyxin B 5000 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30255 8. | CGMP Deviations; deficiencies observed during FDA inspection | Dabur India Limited / 8996 tubes | Class II | Ongoing |
| D-0636-2026 | 06-02-2026 | Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30354 8. | CGMP Deviations; deficiencies observed during FDA inspection | Dabur India Limited / 4374 tubes | Class II | Ongoing |
| D-0641-2026 | 06-02-2026 | Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units), Neomycin Sulfate 5 mg, Polymixin B 5000 units, 0.9g packets, 144 packets per box, 130g, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 1 03 52410 30253 1. | CGMP Deviations; deficiencies observed during FDA inspection | Dabur India Limited / 3006 tubes | Class II | Ongoing |
| D-0633-2026 | 06-02-2026 | Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 3.5 mg, Polymyxin-B Sulfate 5,000 units, net wt. 2oz (57g) tubes, Distributed by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 10096 77162 9. | CGMP Deviations; deficiencies observed during FDA inspection | Dabur India Limited / 84 tubes | Class II | Ongoing |
| D-0640-2026 | 06-02-2026 | Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0. | CGMP Deviations; deficiencies observed during FDA inspection | Dabur India Limited / 4,944 tubes | Class II | Ongoing |
| D-0635-2026 | 06-02-2026 | Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 count box, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30352 4. | CGMP Deviations; deficiencies observed during FDA inspection | Dabur India Limited / 1087 tubes | Class II | Ongoing |
| D-0618-2026 | 06-02-2026 | Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Boston, 55 6th Rd Woburn, Massachusetts 01801-1767. | Incorrect product formulation: bag did not contain copper and famotidine per label. | Central Admixture Pharmacy Services, Inc. / One (1) patient-specific TPN prescription. | Class II | Ongoing |
| D-0629-2026 | 06-02-2026 | Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g) Tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10461 5. | CGMP Deviations; deficiencies observed during FDA inspection | Dabur India Limited / 1102 tubes | Class II | Ongoing |
| D-0632-2026 | 06-02-2026 | Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g), Product distributed by: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC 3 66715 97310 8. | CGMP Deviations; deficiencies observed during FDA inspection | Dabur India Limited / 1225 tubes | Class II | Ongoing |
| D-0630-2026 | 06-02-2026 | Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomycin sulphate 3.5 mg, polymyxin B sulphate 5000 units, Net Wt. 0.5 oz (14g) tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10372 4. | CGMP Deviations; deficiencies observed during FDA inspection | Dabur India Limited / 2503 tubes | Class II | Ongoing |
| D-0637-2026 | 06-02-2026 | Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC X004WB4LKT. | CGMP Deviations; deficiencies observed during FDA inspection | Dabur India Limited / 1185 tubes | Class II | Ongoing |
| D-0654-2026 | 06-01-2026 | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-561-30 | Failed Impurities/Degradation Specifications | SUN PHARMACEUTICAL INDUSTRIES INC / 9,048 bottles | Class III | Ongoing |
| D-0620-2026 | 06-01-2026 | BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle, Manufactured For: Beekeeper's Naturals USA Inc., Covina, CA 91789. | Microbial Contamination of Non-Sterile Products | BEEKEEPER'S NATURALS USA INC. / 1680 bottles | Class I | Ongoing |
| D-0597-2026 | 06-01-2026 | Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-644-30 Package NDCs: 67877-578-14; 67877-578-30; 67877-578-01; 67877-578-05; 67877-576-14; 67877-576-30; 67877-576-01; 67877-576-05; 67877-577-14; 67877-577-30; 67877-577-01; 67877-577-05; 67877-643-14; 67877-643-30; 67877-643-01; 67877-643-05; 67877-644-14; 67877-644-30; 67877-644-01; 67877-644-05; 67877-436-14; 67877-436-30; 67877-436-01; 67877-436-05; 67877-437-14; 67877-437-30; 67877-437-01; 67877-437-05; 67877-438-14; 67877-438-30; 67877-438-01; 67877-438-05 | Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis | Ascend Laboratories, LLC / 360 30-count bottles | Class II | Ongoing |
| D-0608-2026 | 06-01-2026 | Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31 Package NDCs: 66758-240-01; 66758-240-31; 66758-239-01; 66758-239-31; 66758-241-01; 66758-241-31; 66758-242-01; 66758-242-31; 66758-237-01; 66758-237-31; 66758-235-01; 66758-235-31; 66758-236-01; 66758-236-31; 66758-238-01; 66758-238-31 | Labeling: Incorrect or Missing Lot and/or Exp Date | Sandoz Inc / 7,803 bottles | Class III | Ongoing |
| D-0669-2026 | 05-29-2026 | Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924, UPC 69685696529 | Subpotent drug | Gasco Industrial Corp. / N/A | Class II | Ongoing |
| D-0670-2026 | 05-29-2026 | Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana Llana Rio Piedras, PR 00924, UPC 659685696567. | Subpotent drug | Gasco Industrial Corp. / N/A | Class II | Ongoing |
| D-0668-2026 | 05-29-2026 | Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter), Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924 | Subpotent drug | Gasco Industrial Corp. / N/A | Class II | Ongoing |
| D-0587-2026 | 05-29-2026 | GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett, Inc., Seymour, IN 47274, Packaged by GSMS Incorporated, Camarillo, CA 93012. NDC 51407-268-90. Package NDCs: 51407-267-90; 51407-268-90 | Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint. | Golden State Medical Supply Inc. / 2,961 bottles | Class II | Ongoing |
| D-0667-2026 | 05-29-2026 | Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7 87302 12363 6. | Subpotent drug | Gasco Industrial Corp. / N/A | Class II | Ongoing |
| D-0665-2026 | 05-29-2026 | Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: Gasco Industrial Corp., PO Box 1360 Gurabo PR 00778 Made in USA UPC 7 87302 13044 3 | Subpotent drug | Gasco Industrial Corp. / N/A | Class II | Ongoing |
| D-0666-2026 | 05-29-2026 | Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured by: Gasco Industrial Corp., PO Box 1360, Gurabo, PR 00778, Made in USA | Subpotent drug | Gasco Industrial Corp. / N/A | Class II | Ongoing |
| D-0607-2026 | 05-29-2026 | Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Baska Ujeti Road, Ujeti Halol-289350, Gujarat, India, NDC 47335-633-49. Package NDCs: 47335-631-48; 47335-631-49; 47335-632-48; 47335-632-49; 47335-633-48; 47335-633-49 | Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution | SUN PHARMACEUTICAL INDUSTRIES INC / N/A | Class II | Ongoing |
| D-0622-2026 | 05-28-2026 | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31. Package NDCs: 54365-400-31 | Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. | CareFusion 213, LLC / N/A | Class II | Ongoing |
| D-0611-2026 | 05-28-2026 | Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120-04. Package NDCs: 27241-118-04; 27241-118-05; 27241-119-04; 27241-119-05; 27241-120-04; 27241-120-05 | CGMP Deviations | Ajanta Pharma USA Inc / 3648 bottles | Class II | Ongoing |
| D-0562-2026 | 05-28-2026 | Extra strength Antacid Calcium Carbonate 750 mg, chewable tablets, 96-count bottle, DISTRIBUTED BY CASEY'S MARKETING COMPANY, ANKENY, IA 50521, UPC: 0 98437 24361 9. | Presence of foreign substance: small metallic particles in chewable tablets. | Guardian Drug Co. Inc. / | Class II | Ongoing |
| D-0563-2026 | 05-28-2026 | 24/7 life BY 7-ELEVEN, Extra strength Antacid Tablets, Calcium Carbonate 750 mg, 96 chewable tablets, DISTRIBUTED BY 7-ELEVEN, IRVING, TX 75063, UPC 0 5254863573 2. | Presence of foreign substance: small metallic particles in chewable tablets. | Guardian Drug Co. Inc. / | Class II | Ongoing |
| D-0577-2026 | 05-28-2026 | EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-171-68. Package NDCs: 41163-171-75; 41163-171-68 | Presence of foreign substance: small metallic particles in chewable tablets. | Guardian Drug Co. Inc. / | Class II | Ongoing |
| D-0570-2026 | 05-28-2026 | Harris Teeter, ULTRA STRENGTH ANTACID, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, Distributed by: Harris Teeter, LLC.,MATTHEWS, NC 28105, UPC: 0 72036-73108-1. | Presence of foreign substance: small metallic particles in chewable tablets. | Guardian Drug Co. Inc. / | Class II | Ongoing |
| D-0558-2026 | 05-28-2026 | HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle, Haleon, Warren, NJ 07059, UPC 3 07660 74610 2. | Presence of foreign substance: small metallic particles in chewable tablets. | Guardian Drug Co. Inc. / | Class II | Ongoing |
| D-0576-2026 | 05-28-2026 | EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-129-22. Package NDCs: 41163-129-66; 41163-129-22 | Presence of foreign substance: small metallic particles in chewable tablets. | Guardian Drug Co. Inc. / | Class II | Ongoing |
| D-0575-2026 | 05-28-2026 | GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-171-68. Package NDCs: 50804-171-68 | Presence of foreign substance: small metallic particles in chewable tablets. | Guardian Drug Co. Inc. / | Class II | Ongoing |
| D-0564-2026 | 05-28-2026 | MARKET BASKET ANTACID Calcium Carbonate 1000 mg, ULTRA STRENGTH, 72 Tablets, Distributed by: De Moules Supermarkets, Inc.,Tewksbury, Mass 01875, UPC 0 49705 83149 6. | Presence of foreign substance: small metallic particles in chewable tablets. | Guardian Drug Co. Inc. / | Class II | Ongoing |
| D-0566-2026 | 05-28-2026 | CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-178-23. Package NDCs: 72476-178-23 | Presence of foreign substance: small metallic particles in chewable tablets. | Guardian Drug Co. Inc. / | Class II | Ongoing |
| D-0578-2026 | 05-28-2026 | TopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-128-22. Package NDCs: 76162-128-22 | Presence of foreign substance: small metallic particles in chewable tablets. | Guardian Drug Co. Inc. / | Class II | Ongoing |
| D-0572-2026 | 05-28-2026 | HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82514 5. | Presence of foreign substance: small metallic particles in chewable tablets. | Guardian Drug Co. Inc. / | Class II | Ongoing |
| D-0559-2026 | 05-28-2026 | HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 750 mg, 330-count bottle, Haleon, Warren, NJ 07059, UPC 3 0766 3072 10 9. | Presence of foreign substance: small metallic particles in chewable tablets. | Guardian Drug Co. Inc. / | Class II | Ongoing |
| D-0565-2026 | 05-28-2026 | CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-127-80. Package NDCs: 72476-127-80; 72476-127-82 | Presence of foreign substance: small metallic particles in chewable tablets. | Guardian Drug Co. Inc. / | Class II | Ongoing |
| D-0567-2026 | 05-28-2026 | DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg, 96 Tablets, Distributed by: Drug Mart- Food Fair Medina, OH 44256, UPC: 0 93351 03992 8. | Presence of foreign substance: small metallic particles in chewable tablets. | Guardian Drug Co. Inc. / | Class II | Ongoing |
| D-0571-2026 | 05-28-2026 | HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82497 1. | Presence of foreign substance: small metallic particles in chewable tablets. | Guardian Drug Co. Inc. / | Class II | Ongoing |
| D-0569-2026 | 05-28-2026 | FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS, LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA., UP: 0 32251-92282-4. | Presence of foreign substance: small metallic particles in chewable tablets. | Guardian Drug Co. Inc. / | Class II | Ongoing |
| D-0623-2026 | 05-28-2026 | BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30. Package NDCs: 54365-400-30 | Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. | CareFusion 213, LLC / N/A | Class II | Ongoing |
| D-0624-2026 | 05-28-2026 | BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31. Package NDCs: 54365-400-31 | Non-Sterility: Due to presence of Aspergillus penicillioides. | CareFusion 213, LLC / 193,440 applicators | Class I | Ongoing |
| D-0625-2026 | 05-28-2026 | BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30. Package NDCs: 54365-400-30 | Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. | CareFusion 213, LLC / 178,000 applicators | Class I | Ongoing |
| D-0561-2026 | 05-28-2026 | Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 1000 mg, 72 chewable tablets, Distributed by: Amerisourcebergen, 1 West First Avenue, Conshohocken, PA, 19428, NDC 24385-595-23. Package NDCs: 24385-595-23 | Presence of foreign substance: small metallic particles in chewable tablets. | Guardian Drug Co. Inc. / | Class II | Ongoing |
| D-0560-2026 | 05-28-2026 | Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 750 mg, chewable, 96-count bottle, Distributed by: Amerisourcebergen, 1 West First Avenue, Conshohocken, PA, 19428, NDC 24385-106-80. Package NDCs: 24385-106-80 | Presence of foreign substance: small metallic particles in chewable tablets. | Guardian Drug Co. Inc. / | Class II | Ongoing |
| D-0557-2026 | 05-28-2026 | KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-count bottle, MANUFACTURED BY: GUARDIAN DRUG COMPANY, INC., 2 CHARLES COURT/DAYTON, NJ 08810, FOR: Costco Wholesale Corporation, 999 Lake Drive, Issaquah, WA 98027, NDC 63981-171-80 Package NDCs: 63981-171-80 | Presence of foreign substance: small metallic particles in chewable tablets. | Guardian Drug Co. Inc. / | Class II | Ongoing |
| D-0574-2026 | 05-28-2026 | GOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-129-22. Package NDCs: 50804-129-22 | Presence of foreign substance: small metallic particles in chewable tablets. | Guardian Drug Co. Inc. / | Class II | Ongoing |
| D-0573-2026 | 05-28-2026 | H.E.B Extra Strength Calcium Carbonate Antacid Tablets, Calcium Carbonate 750 mg, 96 Chewable Tablets, MADE WITH PRIDE & CARE FOR H.E.B, 646 S. FLORES ST, SAN ANTONIO, TX, NDC 37808-136-22. Package NDCs: 37808-136-22 | Presence of foreign substance: small metallic particles in chewable tablets. | Guardian Drug Co. Inc. / | Class II | Ongoing |
| D-0568-2026 | 05-28-2026 | FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS, LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA., NDC 55319-171-68. Package NDCs: 55319-171-68 | Presence of foreign substance: small metallic particles in chewable tablets. | Guardian Drug Co. Inc. / | Class II | Ongoing |
| D-0579-2026 | 05-28-2026 | TopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-129-68. Package NDCs: 76162-129-68 | Presence of foreign substance: small metallic particles in chewable tablets. | Guardian Drug Co. Inc. / | Class II | Ongoing |
| D-0584-2026 | 05-27-2026 | Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, 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: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint. | Lannett Company Inc. / 3984 bottles | Class II | Ongoing |
| D-0588-2026 | 05-27-2026 | Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430, NDC 68462-556-29 Package NDCs: 68462-556-84; 68462-556-29; 68462-394-84; 68462-394-29 | Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities. | Glenmark Pharmaceuticals Inc., USA / | Class II | Ongoing |
| D-0594-2026 | 05-27-2026 | Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03. Package NDCs: 27241-051-03; 27241-051-08; 27241-052-03; 27241-052-08; 27241-053-03; 27241-053-08; 27241-054-03; 27241-054-08; 27241-055-03; 27241-055-08; 27241-056-03; 27241-056-08 | Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg. | Ajanta Pharma USA Inc / 6,143 bottles | Class II | Ongoing |
| D-0599-2026 | 05-22-2026 | Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-058-10 | Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona | SUN PHARMACEUTICAL INDUSTRIES INC / | Class II | Ongoing |
| D-0586-2026 | 05-22-2026 | Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by: Zap Inc., 350 Joe Frank Harris Parkway, SE, Emerson, GA 30137, NDC 66949-133-85. Package NDCs: 66949-133-24; 66949-133-85; 66949-133-01 | Microbial contamination of sterile products | Zep Inc / 5 drums | Class II | Ongoing |
| D-0598-2026 | 05-22-2026 | Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-762-10 | Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona | SUN PHARMACEUTICAL INDUSTRIES INC / | Class II | Ongoing |
| D-0603-2026 | 05-21-2026 | Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30 Package NDCs: 43498-310-30 | Defective container:may contain bottles with incomplete seals | Keystone Industries / 150 units | Class II | Ongoing |
| D-0602-2026 | 05-21-2026 | DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental Health Products, Inc, 2614 North Sugar Bush Road, New Franken, WI 54229. NDC 69634-020-30 Package NDCs: 69634-020-30 | Defective container:may contain bottles with incomplete seals | Keystone Industries / 150 units | Class II | Ongoing |
| D-0601-2026 | 05-21-2026 | Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le Vergne, TN 37086, NDC 43128-034-30. Package NDCs: 43128-034-30 | Defective container:may contain bottles with incomplete seals | Keystone Industries / 150 units | Class II | Ongoing |
| D-0600-2026 | 05-21-2026 | Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g), Manufactured for: Pearson Dental Supply Inc., Sylmar, CA 91342 USA, NDC 43305-0009-3. Package NDCs: 43305-0009-3 | Defective container:may contain bottles with incomplete seals | Keystone Industries / 900 units | Class II | Ongoing |
| D-0605-2026 | 05-21-2026 | PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson, CA 90810. NDC 68987-001-30 Package NDCs: 68987-001-30 | Defective container:may contain bottles with incomplete seals | Keystone Industries / 450 units | Class II | Ongoing |
| D-0604-2026 | 05-21-2026 | Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay, WI 54311. NDC 69483-001-30 Package NDCs: 69483-001-30 | Defective container:may contain bottles with incomplete seals | Keystone Industries / 450 units | Class II | Ongoing |
| D-0606-2026 | 05-21-2026 | safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA, NDC 67239-0223-1. Package NDCs: 67239-0223-1 | Defective container:may contain bottles with incomplete seals | Keystone Industries / 150 units | Class II | Ongoing |
| D-0691-2026 | 05-19-2026 | Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, Shimoga Chemicals Address -W-57A, MIDC Kupwad Samgli, Maharashtra, 416436, India. | cGMP deviations | Shimoga Chemicals / N/A | Class II | Ongoing |
