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 December 05, 2025 and include a total of 17230 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0145-2026 | 10-28-2025 | Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-047-88. Package NDCs: 57664-047-88; 57664-046-88; 57664-048-88; 57664-049-88; 57664-050-88; 57664-051-88; 57664-052-88; 57664-083-88; 57664-084-88; 57664-085-88; 57664-086-88; 57664-087-88; 57664-088-88 | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. | SUN PHARMACEUTICAL INDUSTRIES INC / N/A | Class II | Ongoing |
| D-0146-2026 | 10-28-2025 | Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-048-88. Package NDCs: 57664-047-88; 57664-046-88; 57664-048-88; 57664-049-88; 57664-050-88; 57664-051-88; 57664-052-88; 57664-083-88; 57664-084-88; 57664-085-88; 57664-086-88; 57664-087-88; 57664-088-88 | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. | SUN PHARMACEUTICAL INDUSTRIES INC / N/A | Class II | Ongoing |
| D-0147-2026 | 10-28-2025 | Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-049-88. Package NDCs: 57664-047-88; 57664-046-88; 57664-048-88; 57664-049-88; 57664-050-88; 57664-051-88; 57664-052-88; 57664-083-88; 57664-084-88; 57664-085-88; 57664-086-88; 57664-087-88; 57664-088-88 | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. | SUN PHARMACEUTICAL INDUSTRIES INC / N/A | Class II | Ongoing |
| D-0150-2026 | 10-28-2025 | Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-052-88. Package NDCs: 57664-047-88; 57664-046-88; 57664-048-88; 57664-049-88; 57664-050-88; 57664-051-88; 57664-052-88; 57664-083-88; 57664-084-88; 57664-085-88; 57664-086-88; 57664-087-88; 57664-088-88 | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. | SUN PHARMACEUTICAL INDUSTRIES INC / N/A | Class II | Ongoing |
| D-0148-2026 | 10-28-2025 | Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-050-88. Package NDCs: 57664-047-88; 57664-046-88; 57664-048-88; 57664-049-88; 57664-050-88; 57664-051-88; 57664-052-88; 57664-083-88; 57664-084-88; 57664-085-88; 57664-086-88; 57664-087-88; 57664-088-88 | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. | SUN PHARMACEUTICAL INDUSTRIES INC / N/A | Class II | Ongoing |
| D-0144-2026 | 10-28-2025 | Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-046-88. Package NDCs: 57664-047-88; 57664-046-88; 57664-048-88; 57664-049-88; 57664-050-88; 57664-051-88; 57664-052-88; 57664-083-88; 57664-084-88; 57664-085-88; 57664-086-88; 57664-087-88; 57664-088-88 | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. | SUN PHARMACEUTICAL INDUSTRIES INC / N/A | Class II | Ongoing |
| D-0149-2026 | 10-28-2025 | Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-051-88. Package NDCs: 57664-047-88; 57664-046-88; 57664-048-88; 57664-049-88; 57664-050-88; 57664-051-88; 57664-052-88; 57664-083-88; 57664-084-88; 57664-085-88; 57664-086-88; 57664-087-88; 57664-088-88 | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. | SUN PHARMACEUTICAL INDUSTRIES INC / N/A | Class II | Ongoing |
| D-0143-2026 | 10-27-2025 | 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37 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 | Lack of Assurance of Sterility: Potential for flexible container leaks. | Otsuka ICU Medical LLC / 509,360 100 mL bags | Class II | Ongoing |
| D-0152-2026 | 10-22-2025 | clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India Package NDCs: 16714-849-02; 16714-849-01; 16714-849-03; 16714-850-01; 16714-850-03; 16714-850-02; 16714-851-01; 16714-851-03; 16714-851-02 | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0153-2026 | 10-22-2025 | clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India Package NDCs: 16714-849-02; 16714-849-01; 16714-849-03; 16714-850-01; 16714-850-03; 16714-850-02; 16714-851-01; 16714-851-03; 16714-851-02 | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0154-2026 | 10-22-2025 | clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Package NDCs: 16714-849-02; 16714-849-01; 16714-849-03; 16714-850-01; 16714-850-03; 16714-850-02; 16714-851-01; 16714-851-03; 16714-851-02 | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. | Zydus Pharmaceuticals (USA) Inc / N/A | Class II | Ongoing |
| D-0097-2026 | 10-21-2025 | Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squibb Company, Princeton, NJ 08543, NDC 0003-7125-11 Package NDCs: 0003-7125-11 | Lack of Assurance of Sterility. | Bristol-Myers Squibb Company / 12,778 total vials | Class II | Ongoing |
| D-0121-2026 | 10-21-2025 | TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034, NDC: 50580-378-04. Package NDCs: 50580-378-01; 50580-378-02; 50580-378-03; 50580-378-04; 50580-378-05; 50580-378-06; 50580-378-07; 50580-378-08 | Defective Container | Kenvue Brands LLC / 3,816 bottles | Class II | Ongoing |
| D-0155-2026 | 10-17-2025 | Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for AERO HEALTHCARE US, Valley-Cottage, NY, 10989, NDC 55305-135-01 Package NDCs: 55305-135-01; 55305-135-02; 55305-135-03 | Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg. | Aero Healthcare / N/A | Class II | Ongoing |
| D-0103-2026 | 10-16-2025 | Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, carton NDC 60687-572-32, Individual unit dose: NDC 60687-572-33 Package NDCs: 60687-572-33; 60687-572-32 | Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit | Amerisource Health Services LLC / 3,410 cartons | Class II | Ongoing |
| D-0102-2026 | 10-16-2025 | Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-997-01, Individual unit dose: NDC 68084-997-11 Package NDCs: 68084-996-11; 68084-996-01; 68084-997-11; 68084-997-01 | Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit | Amerisource Health Services LLC / 1,818 cartons | Class II | Ongoing |
| D-0101-2026 | 10-16-2025 | Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-996-01. Individual unit dose: NDC 68084-996-11 Package NDCs: 68084-996-11; 68084-996-01; 68084-997-11; 68084-997-01 | Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit | Amerisource Health Services LLC / 1,970 cartons | Class II | Ongoing |
| D-0119-2026 | 10-15-2025 | Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-02 | Lack of Assurance of Sterility | ProRx LLC / 2,805 vials | Class II | Ongoing |
| D-0116-2026 | 10-15-2025 | Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-08 | Lack of Assurance of Sterility | ProRx LLC / 8,310 vials | Class II | Ongoing |
| D-0114-2026 | 10-15-2025 | Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09 | Lack of Assurance of Sterility | ProRx LLC / 2,809 vials | Class II | Ongoing |
| D-0115-2026 | 10-15-2025 | Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-04 | Lack of Assurance of Sterility | ProRx LLC / 8,400 vials | Class II | Ongoing |
| D-0118-2026 | 10-15-2025 | Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-06 | Lack of Assurance of Sterility | ProRx LLC / 2,649 vials | Class II | Ongoing |
| D-0117-2026 | 10-15-2025 | Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-09 | Lack of Assurance of Sterility | ProRx LLC / 11,119 vials | Class II | Ongoing |
| D-0120-2026 | 10-15-2025 | Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-209-03 | Lack of Assurance of Sterility | ProRx LLC / 2,761 vials | Class II | Ongoing |
| D-0125-2026 | 10-14-2025 | Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0383-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 829 pellets | Class II | Ongoing |
| D-0124-2026 | 10-14-2025 | Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0387-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 829 pellets | Class II | Ongoing |
| D-0135-2026 | 10-14-2025 | Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0382-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 21,324 pellets | Class II | Ongoing |
| D-0130-2026 | 10-14-2025 | Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0363-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 18,124 pellets | Class II | Ongoing |
| D-0133-2026 | 10-14-2025 | Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0365-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 64,924 pellets | Class II | Ongoing |
| D-0123-2026 | 10-14-2025 | Testosterone 25MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0389-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 1,329pellets | Class II | Ongoing |
| D-0129-2026 | 10-14-2025 | Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0402-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 14,329 pellets | Class II | Ongoing |
| D-0128-2026 | 10-14-2025 | Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0401-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 4,829 pellets | Class II | Ongoing |
| D-0127-2026 | 10-14-2025 | Testosterone 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0381-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 4,929 pellets | Class II | Ongoing |
| D-0126-2026 | 10-14-2025 | Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0386-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 529 pellets | Class II | Ongoing |
| D-0134-2026 | 10-14-2025 | Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0366-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 31,124 pellets | Class II | Ongoing |
| D-0132-2026 | 10-14-2025 | Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0380-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 43,424 Pellets | Class II | Ongoing |
| D-0137-2026 | 10-14-2025 | Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0364-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 264,664 pellets | Class II | Ongoing |
| D-0131-2026 | 10-14-2025 | Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0379-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 36,924 pellets | Class II | Ongoing |
| D-0136-2026 | 10-14-2025 | Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0367-01 | CGMP Deviations: Potential presence of metal particulate matter | FARMAKEIO OUTSOURCING LLC / 103,444 pellets | Class II | Ongoing |
| D-0151-2026 | 10-13-2025 | Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-2277-7. | Subpotent drug; Clavulanate Potassium component | Teva Pharmaceuticals USA, Inc / 4680 cartons | Class II | Ongoing |
| D-0096-2026 | 10-10-2025 | Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 62175-322-46 Package NDCs: 62175-320-46; 62175-320-43; 62175-322-46; 62175-322-43 | Failed Dissolution Specifications | Lannett Company Inc. / 46,848 90-count bottles | Class II | Ongoing |
| D-0142-2026 | 10-10-2025 | Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-119-91 Package NDCs: 49884-119-52; 49884-119-91; 49884-125-52; 49884-125-91; 49884-127-52; 49884-127-91; 49884-128-52; 49884-128-91 | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Endo USA, Inc. / 2,035 cartons | Class III | Ongoing |
| D-0030-2026 | 10-10-2025 | Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 Package NDCs: 0904-6665-61; 0904-6666-61; 0904-6667-61 | Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . | The Harvard Drug Group LLC / | Class II | Ongoing |
| D-0140-2026 | 10-10-2025 | Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91 Package NDCs: 49884-119-52; 49884-119-91; 49884-125-52; 49884-125-91; 49884-127-52; 49884-127-91; 49884-128-52; 49884-128-91 | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Endo USA, Inc. / 1,866 cartons | Class III | Ongoing |
| D-0031-2026 | 10-10-2025 | Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag). Package NDCs: 0904-6665-61; 0904-6666-61; 0904-6667-61; 55154-3363-0; 55154-7992-0; 55154-7993-0 | Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . | The Harvard Drug Group LLC / | Class II | Ongoing |
| D-0113-2026 | 10-10-2025 | R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. INJECTION FOR PERIARTICULAR USE; Not for IV Use. THIS IS A COMPOUNDED DRUG. QuVA Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, TX 77478. NDC 70092-1433-50 | Presence of Particulate Matter | QuVa Pharma, Inc. / 75,885 syringes | Class II | Ongoing |
| D-0139-2026 | 10-10-2025 | Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-125-91 Package NDCs: 49884-119-52; 49884-119-91; 49884-125-52; 49884-125-91; 49884-127-52; 49884-127-91; 49884-128-52; 49884-128-91 | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Endo USA, Inc. / 6,655 cartons | Class III | Ongoing |
| D-0099-2026 | 10-10-2025 | HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured by: SAMSUN BIOEPIS Co., Ltd, Incheon, Republic of Korea, NDC 78206-183-01. Package NDCs: 78206-183-99; 78206-183-01; 78206-184-99; 78206-184-01; 78206-185-99; 78206-185-01; 78206-186-99; 78206-186-01; 78206-187-99; 78206-187-01; 78206-187-58; 78206-187-59 | Lack of Assurance of Sterility. | Samsung Bioepis Co., Ltd. / 5,518 packs (11,036 Syringes) 2 syringes/carton) | Class II | Ongoing |
| D-0141-2026 | 10-10-2025 | Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-128-91 Package NDCs: 49884-119-52; 49884-119-91; 49884-125-52; 49884-125-91; 49884-127-52; 49884-127-91; 49884-128-52; 49884-128-91 | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Endo USA, Inc. / 935 cartons | Class III | Ongoing |
| D-0098-2026 | 10-09-2025 | Taoscare Motion Sickness Patches 36-count box, Henan Xinyongtal Medical Technology., Ltd., Address: he nan sheng zhou kou shi huai yang xian gong ye yuan qu, X003SR097N | Marketed Without an Approved NDA/ANDA | ibspot / 3 boxes | Class II | Ongoing |
| D-0025-2026 | 10-09-2025 | FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0102-05. | Labeling: Incorrect or Missing Lot and/or Exp Date | STAQ Pharma, Inc. / | Class III | Ongoing |
| D-0034-2026 | 10-09-2025 | Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rouge, LA 70810, NDC 70512-0520-05 | Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit. | USV Private Limited / 8,952 bottles | Class II | Ongoing |
| D-0100-2026 | 10-09-2025 | Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922. Package NDCs: 51991-746-06; 51991-746-90; 51991-746-05; 51991-747-33; 51991-747-90; 51991-747-10; 51991-748-33; 51991-748-90; 51991-748-10; 51991-750-33; 51991-750-90; 51991-750-05; 51991-750-10 | CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm. | Breckenridge Pharmaceutical, Inc. / 172,263 bottles | Class II | Ongoing |
| D-0023-2026 | 10-09-2025 | Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0104-05. | Labeling: Incorrect or Missing Lot and/or Exp Date | STAQ Pharma, Inc. / | Class III | Ongoing |
| D-0027-2026 | 10-09-2025 | Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose] Package NDCs: 60687-695-11; 60687-695-01 | CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated. | Amerisource Health Services LLC / 27,868 blister packs | Class II | Ongoing |
| D-0024-2026 | 10-09-2025 | Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02. | Labeling: Incorrect or Missing Lot and/or Exp Date | STAQ Pharma, Inc. / | Class III | Ongoing |
| D-0028-2026 | 10-08-2025 | Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden, Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. NDC 0310-1730-30 Package NDCs: 0310-1730-30; 0310-1730-85; 0310-1830-30; 0310-1830-85; 0310-1745-01; 0310-1745-95 | Lack of Assurance of Sterility: | ASTRAZENECA PHARMACEUTICALS / 916 pre-filled syringes | Class II | Ongoing |
| D-0105-2026 | 10-07-2025 | Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10 Package NDCs: 0093-4067-01; 0093-4067-10; 0093-4068-01; 0093-4068-10; 0093-4069-01; 0093-4069-52; 0093-4069-05 | CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots. | Teva Pharmaceuticals USA, Inc / 291,512 bottles | Class II | Ongoing |
| D-0029-2026 | 10-07-2025 | Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ, 08816, Manufactured by Suven Pharmaceuticals Limited, Pashamylaram, Telangana, 205307, India. NDC# 16571-691-01 Package NDCs: 16571-689-01; 16571-690-01; 16571-691-01; 16571-692-01; 16571-693-01; 16571-694-01 | Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg). | Rising Pharma Holding, Inc. / 2,064 100-count bottles | Class II | Ongoing |
| D-0104-2026 | 10-07-2025 | Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4067-01, b) 1000 Capsules, NDC 0093-4067-10 Package NDCs: 0093-4067-01; 0093-4067-10; 0093-4068-01; 0093-4068-10; 0093-4069-01; 0093-4069-52; 0093-4069-05 | CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots. | Teva Pharmaceuticals USA, Inc / 181,659 bottles | Class II | Ongoing |
| D-0106-2026 | 10-07-2025 | Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4069-01, b) 250 Capsules, NDC 0093-4069-52, c) 500 Capsules, NDC 0093-4069-05 Package NDCs: 0093-4067-01; 0093-4067-10; 0093-4068-01; 0093-4068-10; 0093-4069-01; 0093-4069-52; 0093-4069-05 | CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots. | Teva Pharmaceuticals USA, Inc / 107,673 | Class II | Ongoing |
| D-0112-2026 | 10-06-2025 | Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. Package NDCs: 23155-578-01; 23155-579-01; 23155-580-01; 23155-581-01; 23155-582-01; 23155-583-25 | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. | Heritage Pharmaceuticals Inc / 3,750 bottles. | Class II | Ongoing |
| D-0109-2026 | 10-06-2025 | Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. Package NDCs: 23155-578-01; 23155-579-01; 23155-580-01; 23155-581-01; 23155-582-01; 23155-583-25 | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. | Heritage Pharmaceuticals Inc / 5880 bottles. | Class II | Ongoing |
| D-0110-2026 | 10-06-2025 | Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. Package NDCs: 23155-578-01; 23155-579-01; 23155-580-01; 23155-581-01; 23155-582-01; 23155-583-25 | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. | Heritage Pharmaceuticals Inc / 2,418 bottles. | Class II | Ongoing |
| D-0111-2026 | 10-06-2025 | Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. Package NDCs: 23155-578-01; 23155-579-01; 23155-580-01; 23155-581-01; 23155-582-01; 23155-583-25 | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. | Heritage Pharmaceuticals Inc / 5,882 bottles. | Class II | Ongoing |
| D-0108-2026 | 10-06-2025 | Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. Package NDCs: 23155-578-01; 23155-579-01; 23155-580-01; 23155-581-01; 23155-582-01; 23155-583-25 | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. | Heritage Pharmaceuticals Inc / 8,754 bottles. | Class II | Ongoing |
| D-0016-2026 | 10-06-2025 | Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-102-04. Package NDCs: 72578-102-04 | Discoloration | VIONA PHARMACEUTICALS INC / 13080 bottles | Class II | Ongoing |
| D-0107-2026 | 10-06-2025 | Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. Package NDCs: 23155-578-01; 23155-579-01; 23155-580-01; 23155-581-01; 23155-582-01; 23155-583-25 | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. | Heritage Pharmaceuticals Inc / 6,979 bottles. | Class II | Ongoing |
| D-0095-2026 | 10-01-2025 | ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distributed by: Church & Dwight Co., Inc. Ewing, NJ 08628, NDC 10237-469-25 Package NDCs: 10237-469-25 | Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient. | Church & Dwight Co., Inc. / 21,912 bottles | Class II | Ongoing |
| D-0036-2026 | 10-01-2025 | Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Telangana - 502281, INDIA., U.S. Contact Number: 1-866-495-1995, NDC 31722-307-25 (Carton), 31722-307-02 (Vial label). Package NDCs: 31722-305-25; 31722-305-10; 31722-306-25; 31722-307-25; 31722-307-02 | Presence of Particulate Matter: Particulate matter identified as glass | Aspiro Pharma Limited / | Class II | Ongoing |
| D-0035-2026 | 09-29-2025 | Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL, 60093 USA, NDC 55329-811-30. | Subpotent Drug | Medline Industries, LP / 222,800 eaches | Class II | Ongoing |
| D-0005-2026 | 09-29-2025 | AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersburg, PA 17201, Toll Free: 800-345-1329, Package Configuration: a) 4x1 Gallon Case, 5 Gallon Pail, 55 Gallon Drum. | cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded. | Acuity Specialty Products, Inc. / | Class II | Ongoing |
| D-0004-2026 | 09-29-2025 | Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Development Avenue, Chambersburg, PA 17210, Toll Free: 800-345-1329, Package Configurations: a) 6x1000mL Case, b) 4x1 Gallon Case, c) 5 Gallon Pail, d) 55 Gallon Drum. | cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded. | Acuity Specialty Products, Inc. / | Class II | Ongoing |
| D-0014-2026 | 09-29-2025 | Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05. Package NDCs: 42192-501-50; 42192-501-05 | Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications. | Acella Pharmaceuticals, LLC / 4,680 500-count bottles | Class II | Ongoing |
| D-0008-2026 | 09-26-2025 | Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Intramuscular use, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540. NDC: 43598-666-25 Package NDCs: 43598-666-11; 43598-666-25 | Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration. | Dr. Reddy's Laboratories, Inc. / 571 vials | Class II | Ongoing |
| D-0022-2026 | 09-25-2025 | Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 112, Eden Prairie, Minnesota 55344 | cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing. | SV Labs Prescott Corporation / 11,386 tubes | Class II | Ongoing |
| D-0001-2026 | 09-24-2025 | Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06. Package NDCs: 68382-920-06; 68382-920-16; 68382-920-01; 68382-920-30; 68382-920-77; 68382-921-06; 68382-921-16; 68382-921-01; 68382-921-30; 68382-921-77 | Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity | Zydus Pharmaceuticals (USA) Inc / 912 30-count bottles | Class II | Ongoing |
| D-0002-2026 | 09-24-2025 | Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06. Package NDCs: 68382-920-06; 68382-920-16; 68382-920-01; 68382-920-30; 68382-920-77; 68382-921-06; 68382-921-16; 68382-921-01; 68382-921-30; 68382-921-77 | Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity | Zydus Pharmaceuticals (USA) Inc / 600 30-count bottles | Class II | Ongoing |
| D-0122-2026 | 09-23-2025 | Sting Relief Swabs, First Aid Only, 10 Swabs per box, part number 19-001, Manufactured for: Acme United Corporation, 1 Waterview Dr. Shelton, CT, Made in the USA UPC 738743190015 | Product Mix-up | ACME UNITED CORPORATION / 2338 boxes | Class II | Ongoing |
| D-0003-2026 | 09-22-2025 | Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436. | Lack of assurance of sterility. | RC Outsourcing, LLC / 2,669 syringes | Class II | Ongoing |
| D-0017-2026 | 09-19-2025 | Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. Package NDCs: 67877-511-90; 67877-511-05; 67877-511-10; 67877-511-55; 67877-511-33; 67877-511-38; 67877-512-90; 67877-512-05; 67877-512-10; 67877-512-44; 67877-512-33; 67877-512-38; 67877-513-90; 67877-513-05; 67877-513-10; 67877-513-23; 67877-513-33; 67877-513-38; 67877-514-90; 67877-514-05; 67877-514-10; 67877-514-33; 67877-514-38 | Failed Dissolution Specifications | Ascend Laboratories, LLC / 141,984 bottles | Class II | Ongoing |
| D-0020-2026 | 09-19-2025 | Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054 Package NDCs: 67877-511-90; 67877-511-05; 67877-511-10; 67877-511-55; 67877-511-33; 67877-511-38; 67877-512-90; 67877-512-05; 67877-512-10; 67877-512-44; 67877-512-33; 67877-512-38; 67877-513-90; 67877-513-05; 67877-513-10; 67877-513-23; 67877-513-33; 67877-513-38; 67877-514-90; 67877-514-05; 67877-514-10; 67877-514-33; 67877-514-38 | Failed Dissolution Specifications | Ascend Laboratories, LLC / | Class II | Ongoing |
| D-0019-2026 | 09-19-2025 | Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. Package NDCs: 67877-511-90; 67877-511-05; 67877-511-10; 67877-511-55; 67877-511-33; 67877-511-38; 67877-512-90; 67877-512-05; 67877-512-10; 67877-512-44; 67877-512-33; 67877-512-38; 67877-513-90; 67877-513-05; 67877-513-10; 67877-513-23; 67877-513-33; 67877-513-38; 67877-514-90; 67877-514-05; 67877-514-10; 67877-514-33; 67877-514-38 | Failed Dissolution Specifications | Ascend Laboratories, LLC / | Class II | Ongoing |
| D-0018-2026 | 09-19-2025 | Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. Package NDCs: 67877-511-90; 67877-511-05; 67877-511-10; 67877-511-55; 67877-511-33; 67877-511-38; 67877-512-90; 67877-512-05; 67877-512-10; 67877-512-44; 67877-512-33; 67877-512-38; 67877-513-90; 67877-513-05; 67877-513-10; 67877-513-23; 67877-513-33; 67877-513-38; 67877-514-90; 67877-514-05; 67877-514-10; 67877-514-33; 67877-514-38 | Failed Dissolution Specifications | Ascend Laboratories, LLC / | Class II | Ongoing |
| D-0662-2025 | 09-17-2025 | Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52 Package NDCs: 68462-626-52 | CGMP Deviations: Market complaints received for gritty texture (grainy) | Glenmark Pharmaceuticals Inc., USA / 13824 tubes | Class II | Ongoing |
| D-0006-2026 | 09-16-2025 | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15. Package NDCs: 16729-458-15; 16729-458-17; 16729-447-15; 16729-447-17; 16729-448-15; 16729-448-17; 16729-449-15; 16729-449-17; 16729-451-15; 16729-451-17; 16729-450-15; 16729-450-17; 16729-452-15; 16729-452-17; 16729-453-15; 16729-453-17; 16729-454-15; 16729-454-17; 16729-455-15; 16729-455-17; 16729-456-15; 16729-456-17; 16729-457-15; 16729-457-17 | Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range. | ACCORD HEALTHCARE, INC. / 54,432 bottles | Class II | Ongoing |
| D-0015-2026 | 09-16-2025 | Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota Ave Se, Minneapolis, MN 55414-2842 NDC 71139-0012-1 | Subpotent Drug: Testing revealed there was no oxytocin in the IV bag. | IntegraDose Compounding Services LLC / 853/500 mL bags | Class I | Ongoing |
| D-0675-2025 | 09-15-2025 | Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11) Package NDCs: 60687-583-11; 60687-583-21; 60687-594-11; 60687-594-21 | Failed Dissolution Specifications. | Amerisource Health Services LLC / 360 cartons | Class II | Ongoing |
| D-0037-2026 | 09-15-2025 | Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03. Package NDCs: 16571-862-03; 16571-862-09; 16571-862-50; 16571-862-10; 16571-862-12; 16571-863-03; 16571-863-09; 16571-863-50; 16571-863-10 | Failed Tablet/Capsule Specifications | Graviti Pharmaceuticals Private Limited / 46,512/30 count bottles | Class II | Ongoing |
| D-0032-2026 | 09-12-2025 | Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-10. Package NDCs: 16571-402-10; 16571-402-50 | Tablet/Capsules Imprinted with Wrong ID | JB Chemicals and Pharmaceuticals Ltd / 9936 bottles | Class III | Ongoing |
| D-0011-2026 | 09-12-2025 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61, UPC (01)00309047131617 Package NDCs: 0904-7129-61; 0904-7130-61; 0904-7130-06; 0904-7131-61; 0904-7132-61; 0904-7133-61; 0030904713 | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 506 blister packs | Class II | Ongoing |
| D-0012-2026 | 09-12-2025 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7132-61, UPC (01)00309047132614 Package NDCs: 0904-7129-61; 0904-7130-61; 0904-7130-06; 0904-7131-61; 0904-7132-61; 0904-7133-61; 0030904713 | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 866 blister packs | Class II | Ongoing |
| D-0013-2026 | 09-12-2025 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61, UPC (01)00309047133611 NDC 0904-7133-61 Package NDCs: 0904-7129-61; 0904-7130-61; 0904-7130-06; 0904-7131-61; 0904-7132-61; 0904-7133-61; 0030904713 | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 1394 blister packs | Class II | Ongoing |
| D-0009-2026 | 09-12-2025 | Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UPC (01)00309047130061 Package NDCs: 0904-7129-61; 0904-7130-61; 0904-7130-06; 0904-7131-61; 0904-7132-61; 0904-7133-61; 0030904713 | CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 2064 blister packs | Class II | Ongoing |
| D-0666-2025 | 09-12-2025 | mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, 201 g Mel Skin Rx Beverly Hills, CA 90210 | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. | Private Label Skin Care Inc. / N/A | Class II | Ongoing |
| D-0668-2025 | 09-12-2025 | edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) Uptown Medi Spa, Phoenix, AZ. | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. | Private Label Skin Care Inc. / N/A | Class II | Ongoing |
| D-0667-2025 | 09-12-2025 | Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD , 7 oz (201 g), University Skin Institute, 650 University Ave, Ste 200, Sacramento, CA 95825. | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. | Private Label Skin Care Inc. / N/A | Class II | Ongoing |
| D-0033-2026 | 09-12-2025 | Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-50 Package NDCs: 16571-402-10; 16571-402-50 | Tablet/Capsules Imprinted with Wrong ID | JB Chemicals and Pharmaceuticals Ltd / 13,440 bottles | Class III | Ongoing |
| D-0665-2025 | 09-12-2025 | Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl Peroxide 10%) 7oz (201 g), Torreypines.com | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. | Private Label Skin Care Inc. / N/A | Class II | Ongoing |
| D-0664-2025 | 09-12-2025 | Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7 oz (201 g), Monika Kiripolsky, MD Beverly Hills, CA, 90211 | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products. | Private Label Skin Care Inc. / N/A | Class II | Ongoing |
