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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
| D-0621-2026 | 05-18-2026 | PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO | Lack of Assurance of Sterility | PReye LLC / approximate 50 to 60 bottles | Class II | Ongoing |
| D-0593-2026 | 05-18-2026 | Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900, Shoreview, MN, NDC 71139-0190-1. | Subpotent Drug | IntegraDose Compounding Services LLC / 287 units | Class II | Ongoing |
| D-0551-2026 | 05-18-2026 | PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10. Package NDCs: 11980-174-05; 11980-174-10 | Failed Stability Specifications | AbbVie Inc. / 2,736 bottles | Class III | Ongoing |
| D-0552-2026 | 05-18-2026 | Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. NDC: 55150-164-02 Package NDCs: 76420-760-01; 55150-164-02; 70121-1049-5; 67777-419-02 | Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan | Eugia US LLC / 168,300 vials | Class III | Ongoing |
| D-0591-2026 | 05-15-2026 | VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 26 Grams Sorbitol in 120 mL (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-04. | Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 | PAI Holdings LLC / | Class II | Ongoing |
| D-0590-2026 | 05-15-2026 | VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 240 ml (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-08. | Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 | PAI Holdings LLC / | Class II | Ongoing |
| D-0589-2026 | 05-15-2026 | VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 120 ml (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-04. | Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 | PAI Holdings LLC / | Class II | Ongoing |
| D-0592-2026 | 05-15-2026 | VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 52 Grams Sorbitol in 240 mL (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-08. | Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 | PAI Holdings LLC / | Class II | Ongoing |
| D-0581-2026 | 05-14-2026 | Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton) Package NDCs: 63323-696-02; 63323-696-25 | Failed Impurities/Degradations Specifications | Fresenius Kabi USA, LLC / 898,050 vials | Class III | Ongoing |
| D-0555-2026 | 05-14-2026 | Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc. Package NDCs: 76420-633-20; 76420-633-30; 76420-633-60; 76420-633-90; 76420-633-01; 76420-633-05; 76420-633-00; 76420-634-20; 76420-634-30; 76420-634-60; 76420-634-90; 76420-634-01; 76420-634-00; 76420-636-20; 76420-636-30; 76420-636-60; 76420-636-90; 76420-636-01; 76420-623-20; 76420-623-30; 76420-623-60; 76420-623-90; 76420-623-01; 76420-623-00 | CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit. | Asclemed USA Inc. / 50 bottles | Class II | Ongoing |
| D-0550-2026 | 05-14-2026 | Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88. Package NDCs: 0536-5896-53; 0536-5896-88; 0536-5896-71; 0536-5895-53; 0536-5895-88; 0536-5895-71; 0536-5894-53; 0536-5894-88 | Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units. | AVEVA Drug Delivery Systems, Inc. / 59,808 pouches (4,272 Individual Folding Carton (IFC)) | Class III | Ongoing |
| D-0543-2026 | 05-12-2026 | Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20 Package NDCs: 70954-531-10; 70954-531-20; 70954-532-10; 70954-532-20; 70954-533-10; 70954-533-20; 70954-534-10; 70954-534-20; 70954-530-10; 70954-530-20 | Defective Container; packets were found to be either empty or partially full. | ANI Pharmaceuticals, Inc. / 3964 Cartons | Class II | Ongoing |
| D-0554-2026 | 05-12-2026 | Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1. Package NDCs: 65282-1605-1 | Lack of Assurance of Sterility | Spectra Medical Devices, Llc / 210625 ampules | Class II | Ongoing |
| D-0580-2026 | 05-12-2026 | DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol, Gujarat, India, NDC 72603-200-01. Package NDCs: 72603-103-01; 72603-200-01 | Presence of Particulate matter: Particulate matter identified as glass. | SUN PHARMACEUTICAL INDUSTRIES INC / 675 vials | Class I | Ongoing |
| D-0548-2026 | 05-12-2026 | fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1. | Subpotent Drug | IntegraDose Compounding Services LLC / 376 cassettes | Class II | Ongoing |
| D-0542-2026 | 05-11-2026 | Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9. | Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling. | Haleon US Holdings LLC / 285,330 blister cards | Class II | Ongoing |
| D-0546-2026 | 05-08-2026 | cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna, GA 30080, a) NDC 50474-710-79, b) Professional sample, NDC 50474-710-80; c) 3 cartons, STARTER KIT, NDC 50474-710-81. Package NDCs: 50474-700-62; 50474-700-61; 50474-710-79; 50474-710-80; 50474-710-81; 50474-750-10 | Lack of Assurance of Sterility | UCB Biosciences Inc. / 141,708 cartons | Class II | Ongoing |
| D-0556-2026 | 05-05-2026 | Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30. Package NDCs: 67877-499-30; 67877-499-90; 67877-500-30; 67877-500-90; 67877-501-30; 67877-501-90; 67877-502-30; 67877-502-90 | Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications | Ascend Laboratories, LLC / 15,696 x 30's bottles | Class II | Ongoing |
| D-0539-2026 | 05-04-2026 | Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10. Package NDCs: 25021-241-10 | Failed Impurities/Degradation Specifications | Sagent Pharmaceuticals / Lot 656412: 6,200 vials. Lot 659646: 3,328 vials. | Class III | Ongoing |
| D-0536-2026 | 05-01-2026 | Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11 Package NDCs: 68084-203-11; 68084-203-01; 68084-202-11; 68084-202-01 | Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. | Amerisource Health Services LLC / 63,500 tablets | Class III | Ongoing |
| D-0537-2026 | 05-01-2026 | Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11 Package NDCs: 68084-203-11; 68084-203-01; 68084-202-11; 68084-202-01 | Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. | Amerisource Health Services LLC / 225,000 tablets | Class III | Ongoing |
| D-0549-2026 | 05-01-2026 | Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by: Safecor, Columbus, OH. NDC 54859-0516-08 | Presence of a Foreign Substance; black particles observed in liquid | Safecor Health, LLC / 520 syringes | Class II | Ongoing |
| D-0538-2026 | 04-30-2026 | Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01 Package NDCs: 64380-472-01; 64380-472-02; 64380-473-01; 64380-473-02; 64380-474-01; 64380-474-02; 64380-475-01; 64380-475-02; 64380-476-01; 64380-476-02; 64380-477-01; 64380-477-05; 64380-478-01; 64380-478-02 | Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule. | Safecor Health, LLC / 149 capsules | Class II | Ongoing |
| D-0516-2026 | 04-29-2026 | Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06. Package NDCs: 27241-097-06; 27241-097-10; 27241-097-90; 27241-097-05; 27241-098-03; 27241-098-09; 27241-098-10; 27241-164-30; 27241-099-03; 27241-099-90; 27241-099-40 | CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. | Ajanta Pharma Ltd. / 117,168 packs | Class II | Ongoing |
| D-0514-2026 | 04-29-2026 | Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India Package NDCs: 27241-097-06; 27241-097-10; 27241-097-90; 27241-097-05; 27241-098-03; 27241-098-09; 27241-098-10; 27241-164-30; 27241-099-03; 27241-099-90; 27241-099-40 | CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. | Ajanta Pharma Ltd. / 312,894 packs | Class II | Ongoing |
| D-0515-2026 | 04-29-2026 | Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03 Package NDCs: 27241-097-06; 27241-097-10; 27241-097-90; 27241-097-05; 27241-098-03; 27241-098-09; 27241-098-10; 27241-164-30; 27241-099-03; 27241-099-90; 27241-099-40 | CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. | Ajanta Pharma Ltd. / 77,376 packs. | Class II | Ongoing |
| D-0545-2026 | 04-29-2026 | Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; (NDC 70710-1048-3). Package NDCs: 70710-1047-3; 70710-1047-1; 70710-1047-5; 70710-1048-3; 70710-1048-1; 70710-1048-5 | CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit | Zydus Pharmaceuticals (USA) Inc / 10,992 bottles | Class II | Ongoing |
| D-0544-2026 | 04-29-2026 | Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; a) 30 count bottles (NDC 70710-1047-3); b) 100 count bottles (NDC 70710-1047-1). Package NDCs: 70710-1047-3; 70710-1047-1; 70710-1047-5; 70710-1048-3; 70710-1048-1; 70710-1048-5 | CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit | Zydus Pharmaceuticals (USA) Inc / 23,880 bottles | Class II | Ongoing |
| D-0540-2026 | 04-28-2026 | Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07. Package NDCs: 0264-7750-07 | Presence of Particulate Matter. | B BRAUN MEDICAL INC / 95,412 containers | Class I | Ongoing |
| D-0534-2026 | 04-27-2026 | Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-05 Package NDCs: 51407-637-01; 51407-637-05; 51407-638-01 | Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. | Golden State Medical Supply Inc. / 8,526 bottles | Class III | Ongoing |
| D-0547-2026 | 04-27-2026 | Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590-01. Package NDCs: 67877-590-30; 67877-590-60; 67877-590-01; 67877-590-05; 67877-590-10; 67877-591-30; 67877-591-60; 67877-591-01; 67877-591-05; 67877-591-10; 67877-592-30; 67877-592-60; 67877-592-01; 67877-592-05; 67877-592-10; 67877-593-30; 67877-593-60; 67877-593-01; 67877-593-05; 67877-593-10 | Failed Dissolution Specifications | Ascend Laboratories, LLC / 17,304 100-count bottles | Class II | Ongoing |
| D-0535-2026 | 04-27-2026 | Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01 Package NDCs: 51407-637-01; 51407-637-05; 51407-638-01 | Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. | Golden State Medical Supply Inc. / 1,620 bottles | Class III | Ongoing |
| D-0525-2026 | 04-27-2026 | Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Vermont Ave., Glendora, CA 91741, USA, Made in France, NDC 42126-6400-1. Package NDCs: 42126-6400-1 | Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision. | Oasis Medical, Inc. / | Class II | Ongoing |
| D-0553-2026 | 04-24-2026 | MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Pharmacal 1 Pharmacal Way, P.O. Box 198, Jackson, WI 53037. | Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus. | Wisconsin Pharmacal Company / 690 tubes | Class I | Ongoing |
| D-0533-2026 | 04-24-2026 | Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01. Package NDCs: 0527-1301-01; 0527-1301-05; 0527-1301-10; 0527-1231-01; 0527-1231-05; 0527-1231-10 | Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. | Lannett Company Inc. / 44865 bottles | Class III | Ongoing |
| D-0519-2026 | 04-24-2026 | Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1¿ 19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21. Package NDCs: 0480-9257-08; 0480-9256-01; 0480-9263-21; 0480-9259-08; 0480-9258-01; 0480-9262-08; 0480-9260-01 | Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. | Teva Pharmaceuticals USA, Inc / 2,200 kits | Class II | Ongoing |
| D-0541-2026 | 04-24-2026 | Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70748-346-03. Package NDCs: 70748-346-02; 70748-346-03 | Presence of particulate matter: a white thread-like structure in the cartridge | Lupin Pharmaceuticals Inc. / 217,621 pen injectors | Class II | Ongoing |
| D-0501-2026 | 04-23-2026 | Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11 | Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. | Thea Pharma, Inc. / | Class II | Ongoing |
| D-0500-2026 | 04-23-2026 | iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 82584-700-11 Package NDCs: 82584-700-05; 82584-700-11; 82584-700-13 | Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. | Thea Pharma, Inc. / | Class II | Ongoing |
| D-0520-2026 | 04-23-2026 | Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10. Package NDCs: 64980-685-01; 64980-685-10; 64980-686-01; 64980-686-10; 64980-687-01; 64980-687-10; 64980-688-01; 64980-688-10 | Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test | JB Chemicals and Pharmaceuticals Ltd / 675 bottles | Class II | Ongoing |
| D-0518-2026 | 04-22-2026 | BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becton Dickinson and Co. NDC 54365-014-41 Package NDCs: 54365-014-42; 54365-014-41 | Lack of assurance of Sterility: potential product contamination | CareFusion 213, LLC / | Class II | Ongoing |
| D-0517-2026 | 04-22-2026 | BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42. Package NDCs: 54365-014-42; 54365-014-41 | Lack of assurance of Sterility: potential product contamination | CareFusion 213, LLC / | Class II | Ongoing |
