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-0871-2026 | 09-15-2026 | Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with Hang Tag, 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Products Inc., Tarrytown, NY 10591. NDC: 67172-797-15 | Lack of Assurance of Sterility | Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company / | Class II | Ongoing |
| D-0870-2026 | 09-15-2026 | Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) , 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Products Inc., Tarrytown, NY 10591. NDC: 67172-797-15 | Lack of Assurance of Sterility | Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company / 2,356,248 bottles | Class II | Ongoing |
| N/A | 09-14-2026 | Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761; Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC: 51672-1289-1 Package NDCs: 51672-1289-1; 51672-1289-2 | Failed Stability Specifications | SUN PHARMACEUTICAL INDUSTRIES INC / N/A | Not Yet Classified | Ongoing |
| 09-11-2026 | 0.9% Sodium Chloride Injection, 100 mL, USP, ICU Medical, Inc., Lake Forest, Illinois 60045, USA, NDC 0990-7984-23. Package NDCs: 0990-7730-36; 0990-7730-37; 0990-7983-61; 0990-7983-02; 0990-7983-03; 0990-7983-09; 0990-7983-55; 0990-7983-53; 0990-7984-37; 0990-7984-20; 0990-7984-13; 0990-7984-23; 0990-7984-36; 0990-7985-02; 0990-7985-03; 0990-7985-09 | Product Mix-up: 0.9% SODIUM CHLORIDE Injection, USP may potentially contain the overwrap with labeling indicating it to be 0.9% SODIUM CHLORIDE Injection, USP but the actual product within the overwrap may be POTASSIUM CHLORIDE Inj.10 mEq | Otsuka ICU Medical LLC / 258480 bags | Not Yet Classified | Ongoing | |
| D-0853-2026 | 09-04-2026 | Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Vial NDC 0409-5820-11, Carton NDC 0409-5820-01. Package NDCs: 0409-5820-11; 0409-5820-01; 0409-9104-21; 0409-9104-20 | Lack of Assurance of Sterility | Pfizer / N/A | Class II | Ongoing |
| D-0852-2026 | 09-03-2026 | Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC: 64980-599-01 Package NDCs: 64980-599-01; 64980-599-10; 64980-600-01 | Failed Dissolution Specifications | Inventia Healthcare Limited / 13567 bottles | Class II | Ongoing |
| D-0864-2026 | 09-03-2026 | fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City Lake, Fayetteville, AR, NDC 73013-1013-01. | Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026). | OurPharma LLC / 1,610 bags | Class II | Ongoing |
| D-0833-2026 | 08-31-2026 | Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-102-30. | Failed dissolution specifications. | Supernus Pharmaceuticals, Inc. / 11304 bottles | Class III | Ongoing |
| D-0848-2026 | 08-31-2026 | Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada, Dist By: Taro Pharmaceuticals U.S.A. Inc. Hawthorne NY 70532 NDC: 51672-3008-5 Package NDCs: 51672-3008-5; 51672-3008-3 | Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH). | SUN PHARMA /TARO / 65,328 50g jars | Class II | Ongoing |
| D-0868-2026 | 08-28-2026 | Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1685-1 Package NDCs: 70121-1685-1; 70121-1686-1 | Defective Delivery System: Possibility of no medication in the prefilled pen. | Amneal Pharmaceuticals of New York, LLC / 5,694 pens | Class II | Ongoing |
| D-0867-2026 | 08-27-2026 | Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-068-07. Package NDCs: 33342-067-07; 33342-067-44; 33342-067-12; 33342-067-11; 33342-068-07; 33342-068-44; 33342-068-12; 33342-068-11; 33342-069-07; 33342-069-44; 33342-069-12; 33342-069-11; 33342-070-07; 33342-070-15; 33342-070-12; 33342-070-44; 33342-070-11; 33342-071-07; 33342-071-15; 33342-071-12; 33342-071-44; 33342-071-11; 33342-072-07; 33342-072-15; 33342-072-12; 33342-072-44; 33342-072-11 | Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification. | Macleods Pharmaceuticals Limited / 22,032 30-count bottles | Class III | Ongoing |
| D-0830-2026 | 08-26-2026 | Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81. Vial Label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, Single Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-00. Package NDCs: 67457-386-00; 67457-386-81 | Failed Dissolution Specifications | Mylan Pharmaceuticals Inc / 11,336 units | Class II | Ongoing |
| D-0836-2026 | 08-25-2026 | Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01. Package NDCs: 27241-255-01; 27241-254-01; 27241-253-01; 27241-252-01 | Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent. | Ajanta Pharma USA Inc / 403,200 tablets | Class III | Ongoing |
| D-0834-2026 | 08-24-2026 | traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 50111-560-01 Package NDCs: 50111-560-01; 50111-560-02; 50111-560-03; 50111-561-01; 50111-561-02; 50111-561-03; 50111-450-01; 50111-450-02 | Presence of Foreign Tablets/Capsules | Teva Pharmaceuticals USA, Inc / 175,392 bottles | Class II | Ongoing |
| D-0835-2026 | 08-24-2026 | Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-732-10 | Subpotent Drug | ImprimisRx NJ LLC / 772 bottles | Class III | Ongoing |
| D-0831-2026 | 08-24-2026 | Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228. Package NDCs: 76282-670-01; 76282-671-01; 76282-671-05; 76282-672-01; 76282-672-05; 76282-673-01; 76282-673-05 | Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU). | Hikma Pharmaceuticals USA INC. / a) 25,970 bottles; b) 2,384 bottles | Class II | Ongoing |
| D-0866-2026 | 08-21-2026 | Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine (T4) 19 mcg, liothyronine (T3) 4.5 mcg, 100 Tablets, Rx only, Distributed by: Vitruvias Therapeutics, Auburn, AL 36830, Product of USA, NDC 69680-166-00. Package NDCs: 69680-165-00; 69680-166-00; 69680-167-00; 69680-168-00; 69680-169-00 | Superpotent Drug | VITRUVIAS THERAPEUTICS INC / 1955 bottles | Class I | Ongoing |
| D-0828-2026 | 08-21-2026 | Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg Hempseed oil, 2 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-5, UPC 8 50041 64003 7 | CGMP Deviations: Potential contamination of raw material | Lexia LLC / 2,400 2 oz-jars | Class II | Ongoing |
| D-0829-2026 | 08-21-2026 | Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (CDB Isolate 3000mg, HempSeed Oil 2000mg),4 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-6; UPC 8 50041 64004 4 | CGMP Deviations: Potential contamination of raw material | Lexia LLC / 1,200 4 oz-Jar | Class II | Ongoing |
| D-0847-2026 | 08-21-2026 | Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30. Package NDCs: 51407-444-30; 51407-445-30 | Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution | Golden State Medical Supply Inc. / 6791 30-count bottles | Class II | Ongoing |
| D-0858-2026 | 08-20-2026 | Walgreens Lubricant Eye Drops, 0.5 FL OZ (15 mL) 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by Walgreens Co., 200 Wilmot Road, Deerfield, IL 60015, NDC 0363-8833-15. Package NDCs: 0363-8833-15 | Lack of Assurance of Sterility | Sterling Pharmaceutical Services LLC / 199600 packs | Class II | Ongoing |
| D-0857-2026 | 08-20-2026 | Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant Eye Drops, Sterile, 0.5 OZ (15 mL) bottles, Distributed by Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-8833-15. Package NDCs: 0363-8833-15 | Lack of Assurance of Sterility | Sterling Pharmaceutical Services LLC / 301114 bottles | Class II | Ongoing |
| D-0855-2026 | 08-20-2026 | AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) bottle, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-15 Package NDCs: 50268-068-15; 50268-068-02 | Lack of Assurance of Sterility | Sterling Pharmaceutical Services LLC / 12,864 packs | Class II | Ongoing |
| D-0859-2026 | 08-20-2026 | Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, www.reliable1labs.com, NDC 69618-076-55. Package NDCs: 69618-076-55 | Lack of Assurance of Sterility | Sterling Pharmaceutical Services LLC / 47616 bottles | Class II | Ongoing |
| D-0856-2026 | 08-20-2026 | Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, NDC 69618-077-55. Package NDCs: 69618-077-55 | Lack of Assurance of Sterility | Sterling Pharmaceutical Services LLC / 11083 bottles | Class II | Ongoing |
| D-0862-2026 | 08-20-2026 | Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 FL OZ (15 mL) bottles, Distributed by Cameron Pharmaceuticals, LLC, Louisville, KY, 40245, NDC 42494-448-05 | Lack of Assurance of Sterility | Sterling Pharmaceutical Services LLC / 19284 bottles | Class II | Ongoing |
| D-0860-2026 | 08-20-2026 | TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 FL OZ (15 mL) bottles, Manufactured exclusively for TRP Company, Inc. 1575 Delucci Ln, Reno, NV 89502, NDC 17312-430-15. Package NDCs: 17312-430-15 | Lack of Assurance of Sterility | Sterling Pharmaceutical Services LLC / 14538 bottles | Class II | Ongoing |
| D-0863-2026 | 08-20-2026 | AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) EACH, 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-02 (carton) Package NDCs: 50268-068-15; 50268-068-02 | Lack of Assurance of Sterility | Sterling Pharmaceutical Services LLC / 107,377 packs | Class II | Ongoing |
| D-0861-2026 | 08-20-2026 | Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-6488-38 | Lack of Assurance of Sterility | Sterling Pharmaceutical Services LLC / 34368 tubes | Class II | Ongoing |
| D-0840-2026 | 08-19-2026 | Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC#: 60687-481-21, (Individual Dose NDC: 60687-481-11). Package NDCs: 60687-481-11; 60687-481-21; 60687-492-11; 60687-492-21 | Labeling: Label Mix-up | American Health Packaging / 10,953 cartons. | Class III | Ongoing |
| D-0838-2026 | 08-19-2026 | Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-502-01 Package NDCs: 10122-502-01 | Failed Stability Specifications: Out of specification stability result for the protein concentration profile. | Chiesi USA, Inc. / 3,002 vials | Class III | Ongoing |
| D-0869-2026 | 08-19-2026 | 0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018 USA, NDC 0264-1800-32. Package NDCs: 0264-1800-36; 0264-1800-31; 0264-1800-32 | Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene | B BRAUN MEDICAL INC / 201,472 total container | Class I | Ongoing |
| D-0837-2026 | 08-18-2026 | 2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013. NDC: 53462-705-26 Package NDCs: 53462-705-20; 53462-705-23; 53462-705-26 | Cross Contamination with Other Products | Sage Products, LLC / 165,536 packages | Class II | Ongoing |
| D-0850-2026 | 08-17-2026 | Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06 | Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution. | Baxter Healthcare Corporation / 606 bags | Class I | Ongoing |
| D-0839-2026 | 08-17-2026 | Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93. Package NDCs: 0378-5185-93; 0378-5186-93 | Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria | Mylan Pharmaceuticals Inc / 47,662 bottles | Class II | Ongoing |
| D-0849-2026 | 08-17-2026 | 0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, Made in USA, NDC 0338-0049-03 Package NDCs: 0338-0049-01; 0338-0049-02; 0338-0049-03; 0338-0049-04; 0338-0049-10; 0338-0049-41; 0338-0049-11; 0338-0049-31; 0338-0049-48; 0338-0049-18; 0338-0049-38; 0338-0043-03; 0338-0043-04 | Presence of particulate matter: Particulates identified as fiberglass | Baxter Healthcare Corporation / 145,464 500mL bags | Class I | Ongoing |
| D-0824-2026 | 08-14-2026 | THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml - 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914.UPC 8 885014 073293 | Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label. | Allies Group Inc. / 27,492 3mL Sachets | Class II | Ongoing |
| D-0826-2026 | 08-14-2026 | THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 90ml - 3 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 075853 | Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label. | Allies Group Inc. / 2,149 90mL-Tubes | Class II | Ongoing |
| D-0825-2026 | 08-14-2026 | THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 20ml - 0.7 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 074733 | Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label. | Allies Group Inc. / 23,941, 20mL-Tube | Class II | Ongoing |
| D-0823-2026 | 08-14-2026 | THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 50ML - 1.7 fl. oz Tube, Made in U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 073224 | Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label. | Allies Group Inc. / 29,014 50mL Tubes | Class II | Ongoing |
| D-0842-2026 | 08-13-2026 | Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04 | Failed Stability Specifications | Safecor Health, LLC / N/A | Class II | Ongoing |
| D-0841-2026 | 08-13-2026 | Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16 | Failed Stability Specifications | Safecor Health, LLC / N/A | Class II | Ongoing |
| D-0843-2026 | 08-13-2026 | Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16 | Failed Stability Specifications | Safecor Health, LLC / N/A | Class II | Ongoing |
| D-0844-2026 | 08-13-2026 | Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04 | Failed Stability Specifications | Safecor Health, LLC / N/A | Class II | Ongoing |
| D-0845-2026 | 08-13-2026 | Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04 | Failed Stability Specifications | Safecor Health, LLC / N/A | Class II | Ongoing |
| D-0846-2026 | 08-13-2026 | Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04 | Failed Stability Specifications | Safecor Health, LLC / N/A | Class II | Ongoing |
| D-0804-2026 | 08-13-2026 | Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3 | Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria | Apotex Corp. / 6,972 bottles | Class II | Ongoing |
| D-0832-2026 | 08-12-2026 | Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-00 Package NDCs: 0264-7750-00; 0264-7750-10; 0264-7750-20 | Presence of Particulate matter. | B BRAUN MEDICAL INC / 23,688 bags | Class I | Ongoing |
| D-0865-2026 | 08-11-2026 | Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY 11967. NDC 0517-3030-01 Package NDCs: 0517-3030-01 | Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials. | American Regent, Inc. / 31,935 30mL-vials | Class I | Ongoing |
| D-0827-2026 | 08-10-2026 | Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20. Package NDCs: 65219-590-04; 65219-592-10; 65219-594-20 | Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles. | Fresenius Kabi USA, LLC / 4,643 20mL-vials | Class I | Ongoing |
| D-0790-2026 | 08-10-2026 | Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. Inc., Ewing, NJ 08628, UPC 732216301205. | CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing | Church & Dwight Co., Inc. / 318,600 cartons | Class II | Ongoing |
| D-0854-2026 | 08-08-2026 | MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz, Manufactured by: Shantzu Qiwei Industry Co. Ltd, Add: Quiwei Building, Yingloinguan, Xiashan, Chaonan district, Shantou City, Guangdong Province, China | cGMP Deviations | SHANTOU Qiwei industrial Co., Ltd / 2970 units | Class II | Ongoing |
| D-0822-2026 | 08-07-2026 | Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionpharma Inc., Princeton, NJ 08540 NDC 69452-206-20. Package NDCs: 69452-206-20 | Presence of Foreign Tablets/Capsules | Bionpharma Inc. / 14,232 bottles (1,423,200 tablets) | Class III | Ongoing |
| D-0771-2026 | 08-07-2026 | Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10), b) 100-count bottles (NDC 51407-215-01), Rx Only, Manufactured by: Taro Pharmaceutical Industries Ltd., Marketed by: GSMS, Incorporated, Camarillo, CA 93012 USA Package NDCs: 51407-215-01; 51407-215-10 | CGMP deviations: tablets with black specks. | Golden State Medical Supply Inc. / 1200 bottles | Class II | Ongoing |
| D-0810-2026 | 08-06-2026 | Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Galaxy 100 mL Single Dose Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-9557-12. | CGMP Deviations | Baxter Healthcare Corporation / N/A | Class II | Ongoing |
| D-0821-2026 | 08-06-2026 | Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0718-12. | CGMP Deviations | Baxter Healthcare Corporation / N/A | Class II | Ongoing |
| D-0807-2026 | 08-06-2026 | Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total, in 50 mL Single Dose Container (24 bags/carton), Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0714-24. | CGMP Deviations | Baxter Healthcare Corporation / N/A | Class II | Ongoing |
| D-0780-2026 | 08-06-2026 | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-452-17. 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. / N/A | Class II | Ongoing |
| D-0779-2026 | 08-06-2026 | Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451-15) and b) 1000-count bottles, (NDC 16729-451-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India. 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. / N/A | Class II | Ongoing |
| D-0782-2026 | 08-06-2026 | Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India. 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. / N/A | Class II | Ongoing |
| D-0803-2026 | 08-06-2026 | Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2 Package NDCs: 63004-8710-1; 63004-8710-2; 63004-8712-1; 63004-8712-4; 63004-8711-1; 63004-8711-4 | Presence of particulate matter: glass and stopper piece | Mallinckrodt Hospital Products Inc. / 12367 vials | Class II | Ongoing |
| D-0813-2026 | 08-06-2026 | CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-016-10. Package NDCs: 43066-016-10; 43066-009-10 | CGMP Deviations | Baxter Healthcare Corporation / N/A | Class II | Ongoing |
| D-0785-2026 | 08-06-2026 | Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India. 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. / N/A | Class II | Ongoing |
| D-0775-2026 | 08-06-2026 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17. 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. / N/A | Class II | Ongoing |
| D-0820-2026 | 08-06-2026 | Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3583-01. Package NDCs: 0338-3552-48; 0338-3551-48; 0338-3580-48; 0338-3581-01; 0338-3582-01; 0338-3583-01; 0338-0122-04; 0338-0124-04 | CGMP Deviations | Baxter Healthcare Corporation / N/A | Class II | Ongoing |
| D-0784-2026 | 08-06-2026 | Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 16729-456-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India. 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. / N/A | Class II | Ongoing |
| D-0783-2026 | 08-06-2026 | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17. 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. / N/A | Class II | Ongoing |
| D-0819-2026 | 08-06-2026 | Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-9647-12. Package NDCs: 0338-9640-12; 0338-9647-12 | CGMP Deviations | Baxter Healthcare Corporation / N/A | Class II | Ongoing |
| D-0805-2026 | 08-06-2026 | Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3552-48. Package NDCs: 0338-3552-48; 0338-3551-48; 0338-3580-48; 0338-3581-01; 0338-3582-01; 0338-3583-01; 0338-0122-04; 0338-0124-04 | CGMP Deviations | Baxter Healthcare Corporation / N/A | Class II | Ongoing |
| D-0809-2026 | 08-06-2026 | Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, Baxter International Inc., Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-5197-41. Package NDCs: 0338-5197-41 | CGMP Deviations | Baxter Healthcare Corporation / N/A | Class II | Ongoing |
| D-0816-2026 | 08-06-2026 | Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-Dose GALAXY Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-9549-50. Package NDCs: 0338-9545-50; 0338-9545-24; 0338-9549-50; 0338-9549-24; 0338-9553-50; 0338-9553-24 | CGMP Deviations | Baxter Healthcare Corporation / N/A | Class II | Ongoing |
| D-0776-2026 | 08-06-2026 | Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-17. 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. / N/A | Class II | Ongoing |
| D-0818-2026 | 08-06-2026 | Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-995-24. Package NDCs: 43066-993-24; 43066-995-24 | CGMP Deviations | Baxter Healthcare Corporation / N/A | Class II | Ongoing |
| D-0786-2026 | 08-06-2026 | Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas 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. / N/A | Class II | Ongoing |
| D-0778-2026 | 08-06-2026 | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-17. 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. / N/A | Class II | Ongoing |
| D-0814-2026 | 08-06-2026 | Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 43066-360-20. Package NDCs: 43066-150-10; 43066-360-20 | CGMP Deviations | Baxter Healthcare Corporation / N/A | Class II | Ongoing |
| D-0811-2026 | 08-06-2026 | Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60012 USA, NDC 0338-9640-12. Package NDCs: 0338-9640-12; 0338-9647-12 | CGMP Deviations | Baxter Healthcare Corporation / N/A | Class II | Ongoing |
| D-0812-2026 | 08-06-2026 | Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXY Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, NDC 0338-9648-12. Package NDCs: 0338-9644-01; 0338-9644-12; 0338-9646-01; 0338-9646-24; 0338-9648-01; 0338-9648-12 | CGMP Deviations | Baxter Healthcare Corporation / N/A | Class II | Ongoing |
| D-0815-2026 | 08-06-2026 | Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3814-50. Package NDCs: 0338-3410-50; 0338-3410-24; 0338-3612-50; 0338-3612-24; 0338-3814-50; 0338-3814-24 | CGMP Deviations | Baxter Healthcare Corporation / N/A | Class II | Ongoing |
| D-0817-2026 | 08-06-2026 | Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-4114-50. Package NDCs: 0338-3616-50; 0338-3616-24; 0338-4114-50; 0338-4114-24 | CGMP Deviations | Baxter Healthcare Corporation / N/A | Class II | Ongoing |
| D-0806-2026 | 08-06-2026 | MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0126-12. Package NDCs: 0338-0126-12 | CGMP Deviations | Baxter Healthcare Corporation / N/A | Class II | Ongoing |
| D-0777-2026 | 08-06-2026 | Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-449-17. 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. / N/A | Class II | Ongoing |
| D-0781-2026 | 08-06-2026 | Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-453-17. 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. / N/A | Class II | Ongoing |
| D-0808-2026 | 08-06-2026 | Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3612-50. Package NDCs: 0338-3410-50; 0338-3410-24; 0338-3612-50; 0338-3612-24; 0338-3814-50; 0338-3814-24 | CGMP Deviations | Baxter Healthcare Corporation / N/A | Class II | Ongoing |
| D-0851-2026 | 08-05-2026 | Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For IM or IV Injection Use Only, RX only, Optimal Balance Pharmacy, 2204 Cypress Creek Pkwy Suite F, Houston, TX 77090 | Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin. | OPTIMAL BALANCE PHARMACY / 53 vials | Class I | Ongoing |
| D-0745-2026 | 08-05-2026 | Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1159-3. Package NDCs: 70710-1159-3; 70710-1159-9; 70710-1159-1; 70710-1160-3; 70710-1160-9; 70710-1160-1 | CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. | Zydus Pharmaceuticals (USA) Inc / | Class II | Ongoing |
| D-0788-2026 | 08-04-2026 | Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-004-01; Unit of Sale NDC Number 76045-004-11 Package NDCs: 76045-238-01; 76045-238-10; 76045-004-01; 76045-004-11; 76045-005-01; 76045-005-11; 76045-006-01; 76045-006-11; 76045-007-01; 76045-007-11; 76045-008-01; 76045-008-11 | Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL. | Fresenius Kabi USA, LLC / 625500 syringes | Class I | Ongoing |
| D-0746-2026 | 08-04-2026 | Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34 Package NDCs: 0078-0423-15; 0078-0358-34; 0078-1245-34; 0078-0359-34; 0078-1252-34; 0078-0360-34; 0078-1259-34 | Failed Dissolution Specifications | Novartis Pharmaceuticals Corporation / | Class II | Ongoing |
| D-0761-2026 | 08-03-2026 | TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-002-04. | CGMP Deviations:Noted during FDA inspection | Shoolin Pharma Chem LLP / 20 KG, 40 X 0.500KG(500gm) bags | Class II | Ongoing |
| D-0760-2026 | 08-03-2026 | TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 1715996-29-5), NDC 85702-002-02. | CGMP Deviations:Noted during FDA inspection | Shoolin Pharma Chem LLP / 1KG - 100-0.1KG(100gm) bags | Class II | Ongoing |
| D-0789-2026 | 08-03-2026 | Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04. Package NDCs: 68180-956-01; 68180-956-02; 68180-956-03; 68180-956-04 | Failed content uniformity specifications. | Lupin Pharmaceuticals Inc. / 5082 tubes | Class II | Ongoing |
| D-0763-2026 | 08-03-2026 | SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-08. | CGMP Deviations:Noted during FDA inspection | Shoolin Pharma Chem LLP / 25 KG, 25 X 1.00 KG bags | Class II | Ongoing |
| D-0759-2026 | 08-03-2026 | SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-05 | CGMP Deviations:Noted during FDA inspection | Shoolin Pharma Chem LLP / 25KG, 250-1gm bags | Class II | Ongoing |
| D-0762-2026 | 08-03-2026 | TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-001-08 | CGMP Deviations:Noted during FDA inspection | Shoolin Pharma Chem LLP / 1KG - 20 X 1KG(1000gm) bags | Class II | Ongoing |
| D-0770-2026 | 08-03-2026 | Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3. | CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing | SUN PHARMACEUTICAL INDUSTRIES INC / 1968 Bottles (1000Tablets/Bottle) | Class II | Ongoing |
| D-0773-2026 | 07-31-2026 | Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Made in USA, NDC 0019-1333-65. Package NDCs: 0019-1333-65; 0019-1323-65; 0019-1332-65 | Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. | Liebel-Flarsheim Company LLC / 3,486 500mL-vials | Class I | Ongoing |
| D-0768-2026 | 07-30-2026 | CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51 Package NDCs: 23155-603-51 | Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles. | Heritage Pharmaceuticals Inc / | Class II | Ongoing |
| D-0751-2026 | 07-29-2026 | SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-822-02 | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Apollo Care, LLC / 24,608 vials. | Class II | Ongoing |
| D-0750-2026 | 07-29-2026 | SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-812-03 | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Apollo Care, LLC / 9,762 vials. | Class II | Ongoing |
| D-0756-2026 | 07-29-2026 | SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-722-02 | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Apollo Care, LLC / 500 vials. | Class II | Ongoing |
