Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0495-2024 | 04-12-2024 | Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01 | cGMP Deviations | Dercher Enterprises, Inc., DBA Gordon Laboratories / 5,247 glass jars | Class II | Completed |
| D-0478-2024 | 04-10-2024 | Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01 | Out of specification for assay | Imprimis NJOF, LLC / 15,414 units | Class III | Ongoing |
| D-0476-2024 | 04-10-2024 | Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08 | Subpotent Drug | Imprimis NJOF, LLC / 3320 bottles | Class II | Ongoing |
| D-0469-2024 | 04-09-2024 | Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13 Package NDCs: 59148-006-13; 59148-006-92; 59148-007-13; 59148-007-35; 59148-007-94; 59148-008-13; 59148-008-35; 59148-008-95; 59148-009-13; 59148-009-35; 59148-009-95; 59148-010-13; 59148-010-35; 59148-011-13; 59148-011-35 | Cross Contamination with Other Products | Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. / N/A | Class III | Ongoing |
| D-0466-2024 | 04-09-2024 | Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13 Package NDCs: 59148-006-13; 59148-006-92; 59148-007-13; 59148-007-35; 59148-007-94; 59148-008-13; 59148-008-35; 59148-008-95; 59148-009-13; 59148-009-35; 59148-009-95; 59148-010-13; 59148-010-35; 59148-011-13; 59148-011-35 | Cross Contamination with Other Products | Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. / 108,192/30 count bottles or 7 count blister packs | Class III | Ongoing |
| D-0468-2024 | 04-09-2024 | Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13 Package NDCs: 59148-006-13; 59148-006-92; 59148-007-13; 59148-007-35; 59148-007-94; 59148-008-13; 59148-008-35; 59148-008-95; 59148-009-13; 59148-009-35; 59148-009-95; 59148-010-13; 59148-010-35; 59148-011-13; 59148-011-35 | Cross Contamination with Other Products | Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. / N/A | Class III | Ongoing |
| D-0467-2024 | 04-09-2024 | Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc. Package NDCs: 59148-006-13; 59148-006-92; 59148-007-13; 59148-007-35; 59148-007-94; 59148-008-13; 59148-008-35; 59148-008-95; 59148-009-13; 59148-009-35; 59148-009-95; 59148-010-13; 59148-010-35; 59148-011-13; 59148-011-35 | Cross Contamination with Other Products | Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. / N/A | Class III | Ongoing |
| D-0485-2024 | 04-08-2024 | Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30. Package NDCs: 43598-097-11; 43598-097-30 | Sub-potent Drug; powder discoloration associated with decreased potency | Dr. Reddy's Laboratories, Inc. / 17,332 cartons | Class I | Ongoing |
| D-0486-2024 | 04-08-2024 | Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30. | Sub-potent Drug; powder discoloration associated with decreased potency | Dr. Reddy's Laboratories, Inc. / 2402 cartons | Class I | Ongoing |
| D-0433-2024 | 04-02-2024 | Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC # 39822-0250-01. | Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'. | X-Gen Pharmaceuticals Inc. / 1283 vials | Class III | Terminated |
| D-0434-2024 | 04-02-2024 | Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted before intravenous infusion, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc., Big Flats, NY 14814, NDC # 39822-0255-01. | Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'. | X-Gen Pharmaceuticals Inc. / 1332 vials | Class III | Terminated |
| D-0461-2024 | 03-29-2024 | Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per cartridge, Sperian Eye & Face Protection, Inc., 825 East Highway 151, Platteville, WI 53818. NDC: 0498-0631-37 Package NDCs: 0498-0631-37 | CGMP Deviations | HONEYWELL INC / 10, 605 cartridges | Class II | Terminated |
| D-0439-2024 | 03-28-2024 | Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15 Package NDCs: 0591-2433-45; 0591-2433-15; 0591-2434-45; 0591-2434-15; 0591-2451-45; 0591-2451-15; 0591-2435-45; 0591-2435-15; 0591-2501-45; 0591-2501-15; 0591-2436-45; 0591-2436-15 | Superpotent Drug: The 3-month stability result for assay was found to be above specification limit | Teva Pharmaceuticals USA, Inc / 5,304 3x10-cartons | Class II | Ongoing |
| D-0444-2024 | 03-28-2024 | Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12. | Microbial contamination of a non-sterile product: potential Bacillus cereus contamination. | AvKARE / 153 cartons | Class I | Terminated |
| D-0438-2024 | 03-27-2024 | Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41 | CGMP Deviations | NATCO Pharma Limited / 30 bottles | Class II | Terminated |
| D-0441-2024 | 03-27-2024 | NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion Therapeutics, Ann Arbor, MI 48108, NDC 72426-818-03 Package NDCs: 72426-818-03; 72426-818-99; 72426-818-09 | Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint. | Esperion / 3,480 30-count bottles | Class III | Completed |
| D-0430-2024 | 03-26-2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01 Package NDCs: 68462-850-01; 68462-851-01; 68462-562-01 | Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study. | Glenmark Pharmaceuticals Inc., USA / 6,528 bottles | Class II | Ongoing |
| D-0471-2024 | 03-26-2024 | Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-173-53 Package NDCs: 69097-173-64; 69097-173-53 | Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch. | Cipla USA, Inc. / 59244/3ml FFS packs | Class II | Terminated |
| D-0477-2024 | 03-25-2024 | Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2. Package NDCs: 69238-1605-2; 69238-1605-8 | Failed Dissolution Specifications | Amneal Pharmaceuticals of New York, LLC / 2784 bottles | Class II | Completed |
| D-0443-2024 | 03-25-2024 | Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10 Package NDCs: 70954-201-10; 70954-201-20; 70954-202-10; 70954-202-20; 70954-200-10 | Failed Impurities/Degradation Specifications | Novitium Pharma LLC / 1,003 bottles | Class III | Terminated |
| D-0460-2024 | 03-23-2024 | Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean. UPC 0 82252 03300 5 | Chemical Contamination: Product manufactured with ethanol API that contains methanol | Aruba Aloe Balm N.V. / 5299 bottles | Class I | Ongoing |
| D-0459-2024 | 03-23-2024 | Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC 0 82252 03120 9 (b) 2.2 fl oz (65 mL) plastic bottle, UPC 0 82252 34030 1 , Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean. | Chemical Contamination: Product manufactured with ethanol API that contains methanol | Aruba Aloe Balm N.V. / 9,625 bottles | Class I | Ongoing |
| D-0431-2024 | 03-22-2024 | Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00 Package NDCs: 0264-7750-00; 0264-7750-10; 0264-7750-20 | Lack of assurance of sterility: bags have the potential to leak.. | B. Braun Medical Inc / 7,800 bags | Class II | Terminated |
| D-0432-2024 | 03-22-2024 | fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1 | Lack of Assurance of Sterility: leaking bags | IntegraDose Compounding Services LLC / 187 cassettes | Class II | Ongoing |
| D-0442-2024 | 03-21-2024 | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 Package NDCs: 69238-2261-3; 69238-2261-7; 69238-2261-5 | Superpotent Drug: Due to overfilling of drug powder | Amneal Pharmaceuticals of New York, LLC / 821 bottles | Class I | Terminated |
| D-0427-2024 | 03-21-2024 | VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Pharmaceutical Corp, Ronkonkoma, NY 11779, NDC 52925-112-01 Package NDCs: 52925-112-01; 52925-112-25 | cGMP Diviations | Apothecus Pharmaceutical Corp. / 17,280 paper cartons | Class II | Terminated |
| D-0437-2024 | 03-21-2024 | Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India, NDC 6818-0659-06 | Subpotent Drug | Lupin Pharmaceuticals Inc. / 26,352 bottles | Class II | Terminated |
| D-0448-2024 | 03-19-2024 | Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455 | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / 45 boxes | Class I | Ongoing |
| D-0449-2024 | 03-19-2024 | Weiner Boner Honey, 12g packet, 100% Organic Formula. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / 19 boxes | Class I | Ongoing |
| D-0458-2024 | 03-19-2024 | HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/A | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / 19 boxes | Class I | Ongoing |
| D-0454-2024 | 03-19-2024 | libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / 7 boxes | Class I | Ongoing |
| D-0450-2024 | 03-19-2024 | Flower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / N/A | Class I | Ongoing |
| D-0452-2024 | 03-19-2024 | Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557 | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / 149 boxes | Class I | Ongoing |
| D-0451-2024 | 03-19-2024 | Samurai-X Honey 6800, UPC 2 56891 27553 3. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / N/A | Class I | Ongoing |
| D-0457-2024 | 03-19-2024 | ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'L | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / 4,351 pieces | Class I | Ongoing |
| D-0453-2024 | 03-19-2024 | GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / 12 boxes | Class I | Ongoing |
| D-0455-2024 | 03-19-2024 | SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762 | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / 7 pieces | Class I | Ongoing |
| D-0456-2024 | 03-19-2024 | The GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack, Distributed by Hombres LLC, 130 Maccormick Ave, Suite 105, Costa Mesa, A, UPC 6 61631 26363 1. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil. | Pyramids Wholesale Inc. / 10 boxes | Class I | Ongoing |
| D-0392-2024 | 03-12-2024 | Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01 Package NDCs: 0641-6039-01; 0641-6040-01 | The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot. | Hikma Pharmaceuticals USA Inc. / 22,644 ampuls | Class II | Ongoing |
| D-0445-2024 | 03-12-2024 | Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-100, 10 mL, Use ONLY with Insulins listed on carton, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285. NDC: 0002-0800-01 Package NDCs: 0002-7510-01; 0002-7510-17; 0002-7510-99; 0002-7533-01; 0002-8799-01; 0002-8799-59; 0002-8799-61; 0002-7516-01; 0002-7516-59; 0002-7516-99; 0002-7714-01; 0002-7714-59; 0002-7714-61; 0002-8213-01; 0002-8213-05; 0002-0800-01; 0002-7712-01; 0002-7712-27; 0002-7712-61; 0002-8208-01; 0002-8208-27 | CGMP Deviations | Eli Lilly & Company / 700 vials | Class II | Completed |
| D-0428-2024 | 03-07-2024 | Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 Blister Cards, 28 Tablets Each, Rx only, Teva Pharmaceuticals USA, INC, North Wales, PA 19454, NDC 0093-2140-62 Package NDCs: 0093-2140-28; 0093-2140-62 | Failed Dissolution Specifications | Teva Pharmaceuticals USA, Inc / 92,676 cartons | Class II | Terminated |
| D-0370-2024 | 03-06-2024 | Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20 Package NDCs: 0264-1944-20 | Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks. | B. Braun Medical Inc / 22,752 bags | Class II | Terminated |
| D-0374-2024 | 03-05-2024 | Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15 Package NDCs: 82584-001-05; 82584-002-05; 82584-002-15 | Lack of Assurance of Sterility: Out of specification for volume and compromised container closure. | Thea Pharma, Inc. / 5,476 bottles | Class II | Terminated |
| D-0429-2024 | 03-04-2024 | Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-206-01 | Presence of Particulate Matter. | Par Sterile Products LLC / 466 vials | Class I | Ongoing |
| D-0389-2024 | 03-04-2024 | Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-201-20 Package NDCs: 70954-201-10; 70954-201-20; 70954-202-10; 70954-202-20; 70954-200-10 | Cross Contamination with Other Products:(mycophenolate mofetil). | Novitium Pharma LLC / 3,940 1000-count bottles | Class III | Terminated |
| D-0369-2024 | 03-04-2024 | Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-060-01. Package NDCs: 16714-059-01; 16714-060-01 | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. | SUN PHARMACEUTICAL INDUSTRIES INC / 7,488 bottles | Class II | Ongoing |
| D-0368-2024 | 03-04-2024 | Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141 , Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-059-01. Package NDCs: 16714-059-01; 16714-060-01 | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. | SUN PHARMACEUTICAL INDUSTRIES INC / 47,520 bottles | Class II | Ongoing |
| D-0446-2024 | 03-01-2024 | S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01. | Failed Stability Specifications | Specialty Process Labs LLC / 26 units | Class II | Completed |
| D-0447-2024 | 03-01-2024 | S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03 | Failed Stability Specifications | Specialty Process Labs LLC / 217 units | Class II | Completed |
| D-0380-2024 | 02-29-2024 | TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-098-15. | Lack of Assurance of Sterility | Optikem International, Inc. / 24,216 bottles | Class II | Ongoing |
| D-0378-2024 | 02-29-2024 | TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-178-15. | Lack of Assurance of Sterility | Optikem International, Inc. / 47,832 bottles | Class II | Ongoing |
| D-0377-2024 | 02-29-2024 | TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-040-15. | Lack of Assurance of Sterility | Optikem International, Inc. / 9,936 bottles | Class II | Ongoing |
| D-0381-2024 | 02-29-2024 | TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-027-15. | Lack of Assurance of Sterility | Optikem International, Inc. / 19,344 bottles | Class II | Ongoing |
| D-0379-2024 | 02-29-2024 | TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-172-15. | Lack of Assurance of Sterility | Optikem International, Inc. / 10,536 bottles | Class II | Ongoing |
| D-0383-2024 | 02-29-2024 | TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-158-15. | Lack of Assurance of Sterility | Optikem International, Inc. / 106,704 bottles | Class II | Ongoing |
| D-0384-2024 | 02-29-2024 | hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Riverside, MO 64150 | Lack of Assurance of Sterility | Optikem International, Inc. / 46,621 bottles | Class II | Ongoing |
| D-0375-2024 | 02-29-2024 | TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-032-15. | Lack of Assurance of Sterility | Optikem International, Inc. / 30,240 bottles | Class II | Ongoing |
| D-0382-2024 | 02-29-2024 | TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-013-15. | Lack of Assurance of Sterility | Optikem International, Inc. / 139,656 bottles | Class II | Ongoing |
| D-0376-2024 | 02-29-2024 | TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-002-11. | Lack of Assurance of Sterility | Optikem International, Inc. / 7,248 bottles | Class II | Ongoing |
| D-0436-2024 | 02-29-2024 | FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-9010-1 | Lack of Assurance of Sterility: Firm did not perform process validation. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / 140 vials | Class II | Ongoing |
| D-0435-2024 | 02-29-2024 | Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug - Not for Resale, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0104-1 | Lack of Assurance of Sterility: Firm did not perform process validation. | SSM Health Care St. Louis DBA SSM St. Clare Health Center / 11,798 syringes | Class II | Ongoing |
| D-0385-2024 | 02-22-2024 | Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, Carton NDC 55150-470-06, Vial NDC 55150-470-01. Package NDCs: 55150-470-01; 55150-470-06 | Failed Stability Specification: Water determination was found not complying with specification. | Eugia US LLC / 1160 VIALS | Class II | Terminated |
| D-0391-2024 | 02-20-2024 | Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, NDC 55150-183-11 Package NDCs: 55150-183-02; 55150-183-11 | Failed Impurities/Degradation Specifications: Out of specification for organic impurities | Eugia US LLC / 43,920 vials | Class II | Ongoing |
| D-0366-2024 | 02-20-2024 | Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-314-01 Package NDCs: 55150-313-25; 55150-313-01; 55150-314-25; 55150-314-01 | Failed Dissolution Specifications | Eugia US LLC / 10,080 vials | Class II | Ongoing |
| D-0364-2024 | 02-20-2024 | Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61 | Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint. | Contract Pharmaceuticals Limited Canada / 45,875 bottles | Class III | Ongoing |
| D-0365-2024 | 02-20-2024 | Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60 | Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint. | Contract Pharmaceuticals Limited Canada / 11,750 bottles | Class III | Ongoing |
| D-0363-2024 | 02-20-2024 | Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42 | Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. | Denver Solutions, LLC DBA Leiters Health / 40,890 vials | Class II | Ongoing |
| D-0362-2024 | 02-20-2024 | Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42 | Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. | Denver Solutions, LLC DBA Leiters Health / 10,020 vials | Class II | Ongoing |
| D-0361-2024 | 02-20-2024 | Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42 | Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination. | Denver Solutions, LLC DBA Leiters Health / 40,090 vials | Class II | Ongoing |
| D-0390-2024 | 02-20-2024 | Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 NDC 55150-183-10 Package NDCs: 55150-183-01; 55150-183-10 | Failed Impurities/Degradation Specifications: Out of specification for organic impurities | Eugia US LLC / 335,940 vials | Class II | Ongoing |
| D-0356-2024 | 02-19-2024 | PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL cases, b) 1 G cases, mountain spring scent, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471. | CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility. | Seatex LLC / 1,450 cases | Class II | Terminated |
| D-0358-2024 | 02-19-2024 | 7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 330 Gal. cases, Distributed by: Magnus, 16005 Gateway Drive, Suite 300, Frisco, TX 75033 | CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility. | Seatex LLC / 3 cases | Class II | Terminated |
| D-0357-2024 | 02-19-2024 | PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471 | CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility. | Seatex LLC / 274 cases | Class II | Terminated |
| D-0359-2024 | 02-19-2024 | 7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL cases, Magnus 16005 Gateway Drive, Ste 300, Frisco, TX 75033 | CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility. | Seatex LLC / 1,282 cases | Class II | Terminated |
| D-0360-2024 | 02-19-2024 | PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic, mountain spring scent, 1250 mL cases, Seatex LLC, 445 TX Hwy 36 Rosenberg, YX 77471 | CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility. | Seatex LLC / 480 cases | Class II | Terminated |
| D-0387-2024 | 02-16-2024 | Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in 13g sachets, 25 sachets per box, Made in the Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-097-12 Package NDCs: 65131-097-52; 65131-097-53; 65131-097-12 | Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate. | Global Corporation / 2345 boxes | Class II | Ongoing |
| D-0386-2024 | 02-16-2024 | Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL bottles, Made in Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-098-44 | Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate. | Global Corporation / 9831 bottles | Class II | Ongoing |
| D-0440-2024 | 02-15-2024 | Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor, NJ 08520, NDC 55150-223-10 Package NDCs: 55150-223-10 | Presence of Particulate Matter | Eugia US LLC / 1,552 10ml x 25/carton | Class I | Ongoing |
| D-0349-2024 | 02-14-2024 | Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toronto, Ontario, Cananda, Marketed by: GSMS Incorporated, Camarillo, CA, NDC 60429-195-15 Package NDCs: 60429-195-15 | CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex | Golden State Medical Supply Inc. / 59,712 bottles | Class II | Ongoing |
| D-0327-2024 | 02-13-2024 | Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC# 69238-1273-6 Package NDCs: 69238-1273-6 | Failed Impurities/Degradation Specifications: Out-of-specification test results. | Amneal Pharmaceuticals of New York, LLC / 46,037 Bottles | Class II | Terminated |
| D-0470-2024 | 02-12-2024 | ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card. | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug. | FA Online Inc / 400 capsules | Class I | Terminated |
| D-0348-2024 | 02-12-2024 | Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873. NDC 42571-315-01 Package NDCs: 42571-315-30; 42571-315-90; 42571-315-05; 42571-315-32; 42571-315-11; 42571-315-20; 42571-315-91; 42571-315-01; 42571-316-30; 42571-316-90; 42571-316-32; 42571-316-11; 42571-316-20; 42571-316-91; 42571-316-01 | CGMP Deviations: Out of specification for residual solvents. | Micro Labs Limited / 24,768 bottles | Class II | Ongoing |
| D-0347-2024 | 02-12-2024 | CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use, Rx Only, Net Wt. 50g, Distributed by Bausch Health US, LLC Bridgewater, NJ 08807 USA, Manufactured by: Bausch Health Companies, Inc. Laval Quebec H7L 448, Canada, NDC 0187-0006-25. Package NDCs: 0187-0006-10; 0187-0006-25; 0187-0006-35 | CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated. | MCKESSON CORPORATION / 42 units | Class II | Terminated |
| D-0326-2024 | 02-09-2024 | Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 33326. NDC 60505-0829-1 Package NDCs: 60505-0829-1 | CGMP Deviations: potential presence of Burkholderia cepacia complex | Apotex Corp. / 292,752 bottles | Class II | Ongoing |
| D-0367-2024 | 02-09-2024 | Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only, Manufactured for: Quinn Pharmaceuticals, Boca Raton, FL, www.quinnrx.com | Failed Dissolution Specifications: results slightly under spec at at 9-months. | Stason Pharmaceuticals, Inc. / 54, 131 bottles | Class III | Terminated |
| D-0324-2024 | 02-09-2024 | HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61 | an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 8,198 units | Class II | Terminated |
| D-0388-2024 | 02-09-2024 | Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873, NDC 42571-227-30. Package NDCs: 42571-226-30; 42571-226-90; 42571-226-05; 42571-226-10; 42571-226-32; 42571-226-11; 42571-226-41; 42571-227-30; 42571-227-90; 42571-227-05; 42571-227-10; 42571-227-32; 42571-227-11; 42571-227-41; 42571-228-30; 42571-228-90; 42571-228-05; 42571-228-10; 42571-228-32; 42571-228-11; 42571-228-41 | Failed Stability Specifications: Out of specification for blend uniformity. | Micro Labs Limited / 118,080 bottles | Class II | Terminated |
| D-0372-2024 | 02-07-2024 | Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01 | cGMP Deviations: Products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 70 vials | Class II | Terminated |
| D-0371-2024 | 02-07-2024 | Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10 Package NDCs: 55150-225-05; 55150-226-10 | cGMP Deviations: Products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 70 vials | Class II | Terminated |
| D-0373-2024 | 02-07-2024 | Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceuticals, NDC 60793-0701-10 | cGMP Deviations: Products were stored outside the drug label specifications. | Mckesson Medical-Surgical Inc. Corporate Office / 70 vials | Class II | Terminated |
| D-0345-2024 | 02-06-2024 | Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne, WY 82001, www.getarize.com | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug. | Today The World / 5500 boxes | Class I | Ongoing |
| D-0343-2024 | 02-06-2024 | Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD Productions, Inc. Las Vegas, Nevada | Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug. | Today The World / 7000 boxes | Class I | Ongoing |
| D-0344-2024 | 02-06-2024 | SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Today the World LLC, Vancouver, WA 98683 | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug. | Today The World / 11500 boxes | Class I | Ongoing |
| D-0340-2024 | 02-06-2024 | Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 Package NDCs: 63004-8710-1; 63004-8710-2; 63004-8712-1; 63004-8712-4; 63004-8711-1; 63004-8711-4 | cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified. | Mallinckrodt Hospital Products Inc. / 8 vials involved in recall (16,479 vials distributed) | Class II | Ongoing |
| D-0341-2024 | 02-06-2024 | Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only, Distributed by: Mallinckrodt Hospital Products Inc., Bridgewater, NJ 08807, USA, NDC 43825-200-01 Package NDCs: 43825-200-01 | cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified. | Mallinckrodt Hospital Products Inc. / 421 vials involved in this recall (2,448 vials distributed) | Class II | Ongoing |
| D-0350-2024 | 02-05-2024 | Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 63304-089-13. Package NDCs: 63304-089-13 | Failed Dissolution Specifications: Out of specification for dissolution. | SUN PHARMACEUTICAL INDUSTRIES INC / 54,960 bottles | Class II | Ongoing |
| D-0393-2024 | 02-05-2024 | Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue, New York, New York 10001. | Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States. | Super Chill Products / 3,573 bottles | Class I | Terminated |
| D-0337-2024 | 02-05-2024 | Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release the powder. Add 50mL of water to the bottle and shake vigorously for 1 minute. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202. NDC: 43386-038-60. Package NDCs: 43386-038-60 | Labeling: Incorrect or Missing Package Insert | Lupin Pharmaceuticals Inc. / N/A | Class II | Terminated |
| D-0355-2024 | 02-02-2024 | Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate, Directions for Use: Empty packet contents into a small cup containing 1 to 2 tablespoons of WATER. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Rx Only, Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807, NDC 68682-991-30. Package NDCs: 68682-990-30; 68682-991-30; 68682-102-30; 68682-104-30 | Subpotent Drug: Out of specification for assay | Bausch Health Companies, Inc. / 3,600 cartons | Class II | Completed |
| D-0585-2024 | 02-01-2024 | RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026 | Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil. | Integrity Products / 2500 boxes | Class I | Ongoing |
