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-0042-2026 | 07-30-2025 | B12 Hydroxocobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 25 | Class II | Ongoing |
| D-0077-2026 | 07-30-2025 | Oxytocin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0070-2026 | 07-30-2025 | Zinc Sulfate for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 467 | Class II | Ongoing |
| D-0044-2026 | 07-30-2025 | B5 Dexpanthenol for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 35 | Class II | Ongoing |
| D-0086-2026 | 07-30-2025 | BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute (MHI). | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0045-2026 | 07-30-2025 | B6 (Pyridoxine HCl) for Injections, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0051-2026 | 07-30-2025 | GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 221 | Class II | Ongoing |
| D-0063-2026 | 07-30-2025 | Methylene Blue for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 30 | Class II | Ongoing |
| D-0056-2026 | 07-30-2025 | L-Arginine HCl for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 83 | Class II | Ongoing |
| D-0075-2026 | 07-30-2025 | Elite Stack Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Medical Health Institute (MHI). | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0047-2026 | 07-30-2025 | B-Complex for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. B-Complex with B12 also labeled as manufactured for Synergy Wellness. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0092-2026 | 07-30-2025 | Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Synergy Wellness 60mg, 10mL vial lyophilized. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0050-2026 | 07-30-2025 | GAC for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 3 | Class II | Ongoing |
| D-0054-2026 | 07-30-2025 | Glycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 | Lack of Assurance of Sterility | GenoGenix LLC / 32 | Class II | Ongoing |
| D-0067-2026 | 07-30-2025 | Tri-Immune for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 166 | Class II | Ongoing |
| D-0088-2026 | 07-30-2025 | Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0081-2026 | 07-30-2025 | Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health a) 5% Exosomes, 10 mL vial and b) 10% Exosomes, 5 mL vial, Extension Health a) 20% Exosomes, 10 mL vial, b) 10% Exosomes, 10 mL vial and Medical Health Institute (MHI), a) 10 % Exosomes, 2mL vial, 5mL vial, 10mL vial, b) 5% Exosomes, 2mL vial, 5mL vial, 10mL vial. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0062-2026 | 07-30-2025 | Magnesium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 430 | Class II | Ongoing |
| D-0053-2026 | 07-30-2025 | Glutathione Preserved for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 | Lack of Assurance of Sterility | GenoGenix LLC / 907 | Class II | Ongoing |
| D-0080-2026 | 07-30-2025 | pH Buffered Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Medical Health Institute (MHI), 10mL. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0078-2026 | 07-30-2025 | Pentosan for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0076-2026 | 07-30-2025 | Low Solubility Peptide Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Also labeled as manufactured for CELIA Health. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0084-2026 | 07-30-2025 | Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0049-2026 | 07-30-2025 | Calcium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 184 | Class II | Ongoing |
| D-0093-2026 | 07-30-2025 | Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0052-2026 | 07-30-2025 | Glutathione Magnesium for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0059-2026 | 07-30-2025 | Lipo MIC + L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 172 | Class II | Ongoing |
| D-0072-2026 | 07-30-2025 | CoQ10 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0572-2025 | 07-30-2025 | Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55 Package NDCs: 50242-040-62; 50242-040-86; 50242-214-01; 50242-214-86; 50242-214-03; 50242-214-55; 50242-214-99; 50242-214-83; 50242-215-86; 50242-215-01; 50242-215-03; 50242-215-55; 50242-215-99; 50242-215-83; 50242-227-01; 50242-227-55; 50242-227-99; 50242-227-86 | CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. | Cardinal Health Inc. / 4 units | Class II | Ongoing |
| D-0091-2026 | 07-30-2025 | Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness, 20 mg, 10mL vial lyophilized. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0094-2026 | 07-30-2025 | NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 mg/mL, 10 mL multi-dose amber vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Microbial Contamination of Sterile Products: elevated endotoxin levels | GenoGenix LLC / | Class I | Ongoing |
| D-0069-2026 | 07-30-2025 | Vitamin D3 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 339 | Class II | Ongoing |
| D-0039-2026 | 07-30-2025 | Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 | Lack of Assurance of Sterility | GenoGenix LLC / 235 | Class II | Ongoing |
| D-0064-2026 | 07-30-2025 | N-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 85 | Class II | Ongoing |
| D-0065-2026 | 07-30-2025 | NAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL multi-dose vials, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0066-2026 | 07-30-2025 | Taurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 294 | Class II | Ongoing |
| D-0057-2026 | 07-30-2025 | L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 | Lack of Assurance of Sterility | GenoGenix LLC / 161 | Class II | Ongoing |
| D-0038-2026 | 07-30-2025 | Alpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 17 | Class II | Ongoing |
| D-0061-2026 | 07-30-2025 | Lysine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 45 | Class II | Ongoing |
| D-0046-2026 | 07-30-2025 | Bacteriostatic Water for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health, Extension Health and Medical Health Institute | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0079-2026 | 07-30-2025 | Proline for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0073-2026 | 07-30-2025 | EDTA for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0074-2026 | 07-30-2025 | Elite Stack MSC Exosome Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health, a) 22 billion per vial, 8mL of solution in 10mL vial, b) 44 billion per vial, 8mL of solution in 10mL vial. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0040-2026 | 07-30-2025 | Ascorbic Acid (Vitamin C) for Injection, Preservative Free, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 30 | Class II | Ongoing |
| D-0043-2026 | 07-30-2025 | B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as, manufactured for Synergy Wellness. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0041-2026 | 07-30-2025 | Ascorbic Acid (Vitamin C) for Injection, Preserved, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 1550 | Class II | Ongoing |
| D-0089-2026 | 07-30-2025 | Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 manufactured for Extension Health. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0090-2026 | 07-30-2025 | Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0060-2026 | 07-30-2025 | Lipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 478 | Class II | Ongoing |
| D-0082-2026 | 07-30-2025 | Sterile Saline Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0058-2026 | 07-30-2025 | L-Glutamine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / 15 | Class II | Ongoing |
| D-0087-2026 | 07-30-2025 | Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. | Lack of Assurance of Sterility | GenoGenix LLC / | Class II | Ongoing |
| D-0620-2025 | 07-30-2025 | 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA, NDC 51754-5012-1 (vial); 51754-5012-4 (carton) Package NDCs: 51754-5001-5; 51754-5001-4; 51754-5011-4; 51754-5002-5; 51754-5012-4; 51754-5012-1 | Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested. | Exela Pharma Sciences LLC / N/A | Class II | Ongoing |
| D-0573-2025 | 07-30-2025 | RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01 | CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. | Cardinal Health Inc. / 3 units | Class II | Ongoing |
| D-0571-2025 | 07-30-2025 | Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55. Package NDCs: 50242-040-62; 50242-040-86; 50242-214-01; 50242-214-86; 50242-214-03; 50242-214-55; 50242-214-99; 50242-214-83; 50242-215-86; 50242-215-01; 50242-215-03; 50242-215-55; 50242-215-99; 50242-215-83; 50242-227-01; 50242-227-55; 50242-227-99; 50242-227-86 | CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. | Cardinal Health Inc. / 6 units | Class II | Ongoing |
| D-0575-2025 | 07-29-2025 | Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, Distributed by: Pfizer Inc., New York, NY 10017, Made in Austria, NDC 60793-851-01. Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | Subpotent drug | Pfizer / 29, 004 bottles | Class II | Ongoing |
| D-0598-2025 | 07-29-2025 | 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] | CGMP Deviations: The recalling firm filed for Chapter 11 in September 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 / 26,992 blister packs | Class II | Ongoing |
| D-0580-2025 | 07-25-2025 | Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC 82009-032-10 Package NDCs: 82009-029-05; 82009-030-10; 82009-032-10; 82009-031-30; 82009-031-90 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Breckenridge Pharmaceutical, Inc. / 1,856 bottles | Class II | Ongoing |
| D-0566-2025 | 07-25-2025 | Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-637-31 Package NDCs: 62332-637-31; 62332-637-91; 62332-638-31; 62332-638-91; 62332-645-31; 62332-645-91; 62332-639-31; 62332-639-91; 62332-640-31; 62332-640-91; 2305015142 | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. | Alembic Pharmaceuticals Limited / 9,492 bottles | Class II | Ongoing |
| D-0593-2025 | 07-24-2025 | Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-142-60. Package NDCs: 69097-142-60 | Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point. | Cipla USA, Inc. / 20352 packs (1x 200 MD) | Class III | Ongoing |
| D-0551-2025 | 07-22-2025 | Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25 Package NDCs: 0641-6044-01; 0641-6044-25; 0641-6046-01; 0641-6046-10; 0641-6045-01; 0641-6045-25; 0641-6047-01; 0641-6047-10 | Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds | Hikma Pharmaceuticals USA Inc. / 382,775 1mL vials | Class II | Ongoing |
| D-0589-2025 | 07-22-2025 | BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, Antiseptic, 100 towelettes per carton , For Professional use, Mfg by: Taizhou Kangping Medical, Taizhou, JiangSu, China, NDC: 71310-111-01 | Lack of Assurance of Sterility. | Taizhou Kangping Medical Science And Technology Co., Ltd. / 3.85 million Cartons | Class II | Ongoing |
| D-0659-2025 | 07-21-2025 | Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per carton, AUM Pharmaceuticals, 320 Oser Ave., Hauppauge, NY 11788. | cGMP Deviations | YANGZHOU YULOU PAPER PRODUCTS CO., LTD / 500 cases | Class II | Ongoing |
| D-0584-2025 | 07-21-2025 | Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA, NDC 0006-0033-10 (Shellpack and Print Mat Labels), 0006-0033-30 (Carton Label) Package NDCs: 0006-0005-10; 0006-0005-30; 0006-0005-13; 0006-0033-10; 0006-0033-30; 0006-0033-13; 0006-0325-10; 0006-0325-30; 0006-0325-13; 0006-0335-10; 0006-0335-30; 0006-0335-13 | Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep. | Merck & Co. Inc / 51,320 cartons | Class II | Ongoing |
| D-0576-2025 | 07-21-2025 | Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30 Package NDCs: 67877-499-30; 67877-499-90; 67877-500-30; 67877-500-90; 67877-501-30; 67877-501-90; 67877-502-30; 67877-502-90 | Failed Dissolution Specifications: low dissolution results | Ascend Laboratories, LLC / 8,568 bottles | Class II | Ongoing |
| D-0555-2025 | 07-18-2025 | Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 170 vials | Class II | Ongoing |
| D-0557-2025 | 07-18-2025 | Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 139 vials | Class II | Ongoing |
| D-0562-2025 | 07-18-2025 | Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 194 vials | Class II | Ongoing |
| D-0554-2025 | 07-18-2025 | Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 236 vials | Class II | Ongoing |
| D-0553-2025 | 07-18-2025 | Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 290 vials | Class II | Ongoing |
| D-0559-2025 | 07-18-2025 | Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 143 vials | Class II | Ongoing |
| D-0556-2025 | 07-18-2025 | Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 160 vials | Class II | Ongoing |
| D-0560-2025 | 07-18-2025 | Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 3 x 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 155 vials | Class II | Ongoing |
| D-0564-2025 | 07-18-2025 | Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 176 vials | Class II | Ongoing |
| D-0561-2025 | 07-18-2025 | Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 221 vials | Class II | Ongoing |
| D-0565-2025 | 07-18-2025 | Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 158 vials | Class II | Ongoing |
| D-0563-2025 | 07-18-2025 | Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 190 vials | Class II | Ongoing |
| D-0558-2025 | 07-18-2025 | Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034. | Lack of Processing Controls. | AEQUITA PHARMACY / 146 vials | Class II | Ongoing |
| D-0612-2025 | 07-17-2025 | KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34 | Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. | DermaRite Industries, LLC / 6,973 cartridges | Class I | Ongoing |
| D-0613-2025 | 07-17-2025 | PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08 | Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. | DermaRite Industries, LLC / 5,703 bottles | Class I | Ongoing |
| D-0610-2025 | 07-17-2025 | DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. oz.) bag-n-box (NDC 61924-092-34) , DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. | Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. | DermaRite Industries, LLC / 11,321 bag in boxes | Class I | Ongoing |
| D-0611-2025 | 07-17-2025 | DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08 | Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia. | DermaRite Industries, LLC / 249 bottles | Class I | Ongoing |
| D-0552-2025 | 07-15-2025 | Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10. Package NDCs: 51991-746-06; 51991-746-90; 51991-746-05; 51991-747-33; 51991-747-90; 51991-747-10; 51991-748-33; 51991-748-90; 51991-748-10; 51991-750-33; 51991-750-90; 51991-750-05; 51991-750-10 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit | Breckenridge Pharmaceutical, Inc. / 1,829 60-count bottles | Class II | Ongoing |
| D-0547-2025 | 07-11-2025 | Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120. | CGMP Deviations: The recalling firm filed for Chapter 11 in September 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. | Nostrum Laboratories, Inc. / 60,608 bottles | Class II | Ongoing |
| D-0545-2025 | 07-10-2025 | Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001, Made in Austria, Carton NDC- 60793-702-10 , Syringe NDC-60793-702-04 Package NDCs: 60793-700-01; 60793-700-10; 60793-701-02; 60793-701-10; 60793-702-04; 60793-702-10 | CGMP Deviations; particulates identified during visual inspection | Pfizer Inc. / 19,279 vials | Class II | Ongoing |
| D-0544-2025 | 07-10-2025 | Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001. Made in Austria, Carton NDC - 60793-701-10, Syringe NDC - 60793-701-02 Package NDCs: 60793-700-01; 60793-700-10; 60793-701-02; 60793-701-10; 60793-702-04; 60793-702-10 | CGMP Deviations; particulates identified during visual inspection | Pfizer Inc. / 50,855 2 mL vials | Class II | Ongoing |
| D-0548-2025 | 07-10-2025 | Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-038-00, UPC Code 815195019313 | CGMP Deviations | A.P. Deauville, LLC / 21,265 cases | Class II | Ongoing |
| D-0550-2025 | 07-10-2025 | Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant, 1.8 oz./ 53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-040-00 UPC Code 815195018224 | CGMP Deviations | A.P. Deauville, LLC / 23,467 Cases | Class II | Ongoing |
| D-0549-2025 | 07-10-2025 | Beauty & Skincare Power Stick original nourishing invisible protection roll-on Antiperspirant/Deodorant Spring Fresh, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, NDC# 42913-039-00, UPC Code 815195018194 | CGMP Deviations | A.P. Deauville, LLC / 22,482 Cases | Class II | Ongoing |
| D-0546-2025 | 07-09-2025 | Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04 Package NDCs: 64380-883-04; 64380-884-04; 64380-885-04 | Failed Dissolution Specifications. | Strides Pharma, Inc. / 6,672 bottles | Class II | Ongoing |
| D-0533-2025 | 07-09-2025 | Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18 Package NDCs: 67877-261-30; 67877-261-01; 67877-261-05; 67877-261-18; 67877-261-25; 67877-262-30; 67877-262-01; 67877-262-05; 67877-262-18; 67877-262-25 | CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit. | Ascend Laboratories, LLC / N/A | Class II | Ongoing |
| D-0536-2025 | 07-09-2025 | Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05. | Sub-Potent Drug: Subpotent assay results during stability testing. | Imprimis NJOF, LLC / 2,890 vials | Class III | Completed |
| D-0535-2025 | 07-09-2025 | Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01 | Sub-Potent Drug: Subpotent assay results during stability testing. | Imprimis NJOF, LLC / 6,880 vials | Class II | Completed |
| D-0606-2025 | 07-09-2025 | Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy | Subpotent Drug | Boothwyn Pharmacy LLC / 642 vials | Class II | Ongoing |
| D-0534-2025 | 07-09-2025 | Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-262-18 Package NDCs: 67877-261-30; 67877-261-01; 67877-261-05; 67877-261-18; 67877-261-25; 67877-262-30; 67877-262-01; 67877-262-05; 67877-262-18; 67877-262-25 | CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit. | Ascend Laboratories, LLC / N/A | Class II | Ongoing |
| D-0609-2025 | 07-09-2025 | Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy | Subpotent Drug | Boothwyn Pharmacy LLC / 648 vials | Class II | Ongoing |
| D-0608-2025 | 07-09-2025 | Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy | Subpotent Drug | Boothwyn Pharmacy LLC / 186 vials | Class II | Ongoing |
| D-0607-2025 | 07-09-2025 | Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496 | Subpotent Drug | Boothwyn Pharmacy LLC / 8 vials | Class III | Ongoing |
| D-0604-2025 | 07-07-2025 | Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen, 1 West First Avenue, Conshohocken, PA 19428, Made in China: 100 eaches per box, 30 boxes per case, (3,000 eaches per case), NDC 46122-043-78. Package NDCs: 46122-043-78; 6122407007 | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | MEDLINE INDUSTRIES, LP - Northfield / 66,000 pads | Class II | Ongoing |
| D-0602-2025 | 07-07-2025 | ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walmart, Inc., Bentonville, AR 72716 Walmart: 200 eaches per box, 24 boxes per case (4,800 eaches per case), NDC 49035-814-60. Package NDCs: 49035-814-30; 49035-814-60; 6122407007 | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | MEDLINE INDUSTRIES, LP - Northfield / 3,456,000 pads | Class II | Ongoing |
