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-0297-2025 | 03-06-2025 | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1259-75 | Lack of Assurance of Sterility | QuVa Pharma, Inc. / 1,765 cassettes | Class II | Ongoing |
| D-0296-2025 | 03-06-2025 | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75 | Lack of Assurance of Sterility | QuVa Pharma, Inc. / 2,310 cassettes | Class II | Ongoing |
| D-0295-2025 | 03-06-2025 | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75 | Lack of Assurance of Sterility | QuVa Pharma, Inc. / N/A | Class II | Ongoing |
| D-0287-2025 | 03-05-2025 | PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30 Package NDCs: 51407-444-30; 51407-445-30 | Failed Dissolution Specifications | Golden State Medical Supply Inc. / 2,601 30-count bottles | Class II | Ongoing |
| D-0293-2025 | 03-05-2025 | Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02 Package NDCs: 64380-152-01; 64380-152-02; 64380-151-01; 64380-151-02 | Presence of foreign substance: Presence of Benzene. | Strides Pharma, Inc. / 195,952 Cartons; 30 sachets/Carton. | Class II | Ongoing |
| D-0277-2025 | 03-05-2025 | Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit. | Rising Pharma Holding, Inc. / 1223 bottles | Class II | Ongoing |
| D-0294-2025 | 03-05-2025 | Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-152-02 Package NDCs: 64380-152-01; 64380-152-02; 64380-151-01; 64380-151-02 | Presence of foreign substance: Presence of Benzene. | Strides Pharma, Inc. / 244,412 Cartons; 30 sachets /Carton | Class II | Ongoing |
| D-0418-2025 | 03-05-2025 | La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System, 3 Step Acne Routine Kit, Medicated Gel Cleanser 3.4 fl. oz. (100 mL) Tube, Clarifying Solution 3.4 fl. oz. (100 mL) Tube, Dual Action Acne Treatment 0.7 fl. oz. (20 mL: UPC 883140035275) Tube, (benzoyl peroxide 0.5% and benzoyl peroxide 5.5% and salicylic acid 2%), La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, France, UPC 883140035282 (kit). | cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots. | L'Oreal USA / 14,460 bottles | Class II | Ongoing |
| D-0419-2025 | 03-05-2025 | La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, a) UPC 3606000508804, 20 mL (0.7 fl. oz.) Tube per Carton, b) 883140500759, 40 mL (1.35 fl. oz.) Tube per Carton, La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, France. | cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots. | L'Oreal USA / | Class II | Ongoing |
| D-0417-2025 | 03-05-2025 | La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, 40 mL (135 FL. OZ.) Tube per carton, La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, Laboratoire Dermatologique, CAI 86270, La Roche-Posay, France, UPC 883140500759. | Chemical Contamination: This recall has been initiated due to detected trace levels of benzene. | L'Oreal USA / 2,226,801 bottles | Class II | Ongoing |
| D-0266-2025 | 03-04-2025 | Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured by Adare Pharmaceuticals, Inc., Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409, UPC # 0 41167 0014 0 | CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration. | Chattem Inc / 180,696 cartons | Class II | Ongoing |
| D-0304-2025 | 03-04-2025 | Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6592-04. | Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 224 cartons | Class III | Terminated |
| D-0311-2025 | 03-04-2025 | Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDC 62756-138-04, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India. Package NDCs: 62756-137-02; 62756-137-03; 62756-137-05; 62756-137-04; 62756-137-01; 62756-138-02; 62756-138-03; 62756-138-05; 62756-138-04; 62756-138-01; 62756-139-02; 62756-139-03; 62756-139-05; 62756-139-04; 62756-139-01; 62756-202-01; 62756-202-03; 62756-204-01; 62756-204-03 | Cross Contamination | SUN PHARMACEUTICAL INDUSTRIES INC / 12,876 bottles | Class III | Ongoing |
| D-0312-2025 | 03-04-2025 | Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India. Package NDCs: 62756-137-02; 62756-137-03; 62756-137-05; 62756-137-04; 62756-137-01; 62756-138-02; 62756-138-03; 62756-138-05; 62756-138-04; 62756-138-01; 62756-139-02; 62756-139-03; 62756-139-05; 62756-139-04; 62756-139-01; 62756-202-01; 62756-202-03; 62756-204-01; 62756-204-03 | Cross Contamination | SUN PHARMACEUTICAL INDUSTRIES INC / 852 bottles | Class III | Ongoing |
| D-0448-2025 | 02-28-2025 | Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. Package NDCs: 68462-162-60; 68462-162-01; 68462-162-18; 68462-162-05; 68462-162-10; 68462-163-60; 68462-163-01; 68462-163-18; 68462-163-05; 68462-163-10; 68462-164-60; 68462-164-01; 68462-164-18; 68462-164-05; 68462-164-10; 68462-165-60; 68462-165-01; 68462-165-18; 68462-165-05; 68462-165-10 | CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit | Glenmark Pharmaceuticals Inc., USA / [100 Tablet Bottles] 59,952 bottles; [500 Tablet Bottles] 155,976 bottles | Class II | Ongoing |
| D-0451-2025 | 02-28-2025 | Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05. Package NDCs: 68462-162-60; 68462-162-01; 68462-162-18; 68462-162-05; 68462-162-10; 68462-163-60; 68462-163-01; 68462-163-18; 68462-163-05; 68462-163-10; 68462-164-60; 68462-164-01; 68462-164-18; 68462-164-05; 68462-164-10; 68462-165-60; 68462-165-01; 68462-165-18; 68462-165-05; 68462-165-10 | CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit | Glenmark Pharmaceuticals Inc., USA / 18,696 bottles | Class II | Ongoing |
| D-0449-2025 | 02-28-2025 | Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. Package NDCs: 68462-162-60; 68462-162-01; 68462-162-18; 68462-162-05; 68462-162-10; 68462-163-60; 68462-163-01; 68462-163-18; 68462-163-05; 68462-163-10; 68462-164-60; 68462-164-01; 68462-164-18; 68462-164-05; 68462-164-10; 68462-165-60; 68462-165-01; 68462-165-18; 68462-165-05; 68462-165-10 | CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit | Glenmark Pharmaceuticals Inc., USA / [100 Tablet Bottles] 90,000 bottles; [500 Tablet Bottles] 324,288 bottles | Class II | Ongoing |
| D-0450-2025 | 02-28-2025 | Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-164-05 Package NDCs: 68462-162-60; 68462-162-01; 68462-162-18; 68462-162-05; 68462-162-10; 68462-163-60; 68462-163-01; 68462-163-18; 68462-163-05; 68462-163-10; 68462-164-60; 68462-164-01; 68462-164-18; 68462-164-05; 68462-164-10; 68462-165-60; 68462-165-01; 68462-165-18; 68462-165-05; 68462-165-10 | CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit | Glenmark Pharmaceuticals Inc., USA / 84,048 bottles | Class II | Ongoing |
| D-0274-2025 | 02-28-2025 | Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 200 Wilmont RD, Deerfield, IL, Made in Canada. UPC#: 1 9560203602 8 | Chemical Contamination: Presence of benzene | Sigan Industries Group Inc. / 13,440 tubes | Class II | Ongoing |
| D-0271-2025 | 02-28-2025 | Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05 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 FDA recommended interim limit. | Breckenridge Pharmaceutical, Inc. / 11,125 bottles. | Class II | Ongoing |
| D-0269-2025 | 02-28-2025 | Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. 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 FDA recommended interim limit. | Breckenridge Pharmaceutical, Inc. / 11,100 bottles. | Class II | Ongoing |
| D-0270-2025 | 02-28-2025 | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10 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 FDA recommended interim limit. | Breckenridge Pharmaceutical, Inc. / 14,749 bottles. | Class II | Ongoing |
| D-0285-2025 | 02-27-2025 | Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-530-01 (vial), NDC 55513-530-10 (box). Package NDCs: 55513-530-01; 55513-530-10; 55513-530-20; 55513-546-01; 55513-546-10; 55513-546-20; 55513-924-01; 55513-924-10; 55513-924-91; 55513-924-20; 55513-209-01; 55513-209-10; 55513-209-91; 55513-209-20 | Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months. | Amgen, Inc. / 313,620 Vials | Class II | Ongoing |
| D-0286-2025 | 02-27-2025 | Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc. Thousand Oaks, CA 91320, NDC 55513-546-01 (vial), NDC 55513-546-10 (box). Package NDCs: 55513-530-01; 55513-530-10; 55513-530-20; 55513-546-01; 55513-546-10; 55513-546-20; 55513-924-01; 55513-924-10; 55513-924-91; 55513-924-20; 55513-209-01; 55513-209-10; 55513-209-91; 55513-209-20 | Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months. | Amgen, Inc. / 258,750 Vials | Class II | Ongoing |
| D-0280-2025 | 02-25-2025 | Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93 Package NDCs: 0378-5185-93; 0378-5186-93 | Failed Dissolution Specifications - low dissolution results | MYLAN PHARMACEUTICALS INC / N/A | Class II | Ongoing |
| D-0292-2025 | 02-25-2025 | METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3. Package NDCs: 50090-1494-3; 50090-1494-4; 50090-1494-0; 50090-1494-1; 50090-1494-2 | Presence of Foreign Tablets/Capsules. | A-S Medication Solutions LLC / 411 180-count bottles | Class II | Ongoing |
| D-0258-2025 | 02-24-2025 | Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd, Nagoya, 462-0024 Japan, Marketed by Kowa Pharmaceuticals: Kowa Pharmaceuticals America Inc., Montgomery, AL 36117 USA NDC 66869-404-90 HDPE Bottle, congregated into a shrink wrapped 6-pack further congregated into 24 6-packs in a cardboard case Package NDCs: 66869-104-90; 66869-204-90; 66869-204-07; 66869-404-90; 66869-404-07 | Presence of foreign tablets/capsules | Kowa Pharmaceuticals America / 5,328 Bottles | Class III | Completed |
| D-0273-2025 | 02-24-2025 | Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 801 Broad St Ste 200, Chattanooga, TN 37402. NDC 71687-0011-1 Package NDCs: 71687-0011-1 | Chemical Contamination: Presence of benzene. | Denison Pharmaceuticals, LLC / 642,131 tubes | Class II | Ongoing |
| D-0305-2025 | 02-24-2025 | Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05. | Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim. | Imprimis NJOF, LLC / 2822 bottles | Class III | Ongoing |
| D-0272-2025 | 02-20-2025 | PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, 855-275-2270, NDC 71285-6092-1. | Presence of Particulate Matter | Central Admixture Pharmacy Services, Inc. / 1546 bags | Class I | Ongoing |
| D-0281-2025 | 02-20-2025 | Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency. | Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil. | One Source Nutrition, Inc, / a) 300 individually wrapped capsules b) 20 bottles | Class I | Ongoing |
| D-0248-2025 | 02-18-2025 | Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was repackaged by Turbare Manufacturing, 925 Jeanette Drive, Conway, AR 72032, NDC: 83556-0101-01. | Lack of Assurance of Sterility: due to a quality control process deviation | Turbare Manufacturing / 1,147 syringes | Class II | Completed |
| D-0289-2025 | 02-17-2025 | CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30. Package NDCs: 53329-827-60; 53329-827-36; 53329-827-30; 53329-827-29; 53329-827-40; 53329-827-09; 53329-827-33; 6122405000 | Subpotent Drug | MEDLINE INDUSTRIES, LP - Northfield / 1,639,996 pads | Class II | Ongoing |
| D-0250-2025 | 02-17-2025 | Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 69367028302. | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. | Safecor Health, LLC / 3069 Oral Syringes | Class II | Ongoing |
| D-0288-2025 | 02-17-2025 | Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30. Package NDCs: 53329-811-30; 53329-811-09; 6122404005 | Subpotent Drug | MEDLINE INDUSTRIES, LP - Northfield / 6,669,874 pads | Class II | Ongoing |
| D-0252-2025 | 02-17-2025 | Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by: Safecor, Columbus, OH 43204. NDC: a) 71399748005, b) 39328055750, c) 69618007059. | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. | Safecor Health, LLC / 1535 Oral Syringes | Class II | Ongoing |
| D-0254-2025 | 02-17-2025 | Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054051750. | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. | Safecor Health, LLC / 12390 Oral Syringes | Class II | Ongoing |
| D-0253-2025 | 02-17-2025 | Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00054353244, b) 00121077001, c) 65162068784. | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. | Safecor Health, LLC / 3465 Oral Syringes | Class II | Ongoing |
| D-0251-2025 | 02-17-2025 | Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375. | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. | Safecor Health, LLC / 10992 Oral Syringes | Class II | Ongoing |
| D-0259-2025 | 02-14-2025 | BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31. Package NDCs: 54365-400-31 | Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding. | CareFusion 213, LLC / 205,440 applicators | Class I | Ongoing |
| D-0255-2025 | 02-13-2025 | Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1726-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ Package NDCs: 70710-1726-1; 70710-1726-8 | Failed Impurities/Degradation Specifications | Zydus Pharmaceuticals (USA) Inc / 36,978 vials | Class II | Ongoing |
| D-0276-2025 | 02-13-2025 | Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%), packaged in 3 OZ spray bottles, Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403, UPC 813277019923 and UPC 813277019916 | Chemical Contamination | Johnson, S C and Son, Inc / 493,462 units | Class II | Ongoing |
| D-0268-2025 | 02-13-2025 | POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269 Package NDCs: 0990-7074-26; 0990-7075-14; 0990-7075-26; 0990-7077-14; 0990-7077-26; 0030990707 | Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq | ICU Medical, Inc. / unknown | Class I | Ongoing |
| D-0267-2025 | 02-13-2025 | POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266; Case (01)30309907075267 Package NDCs: 0990-7074-26; 0990-7075-14; 0990-7075-26; 0990-7077-14; 0990-7077-26; 0030990707; 3030990707 | Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container. | ICU Medical, Inc. / 67,488 flexible containers | Class I | Ongoing |
| D-0275-2025 | 02-13-2025 | Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%) packaged in a) 6 OZ (170 g) spray bottles UPC 813277019954 and UPC 813277019800; and b) Twinpack UPC 813277019930; Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403. | Chemical Contamination | Johnson, S C and Son, Inc / 449,502 units | Class II | Ongoing |
| D-0622-2025 | 02-13-2025 | Iodo Blanco Iodides, First Aid Antiseptic, Mercury Free, Iodine 2%, First Aid Antiseptic, Contains 1 fl. oz (30 ml) per bottle, Distributed by: Essential Products, www.essentialproductsusa.com, NDC: 70242-109-01 | Defective Container: broken or leaking bottles. | World Perfumes Inc. / 3,900 bottles | Class II | Ongoing |
| D-0256-2025 | 02-13-2025 | Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1839-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ Package NDCs: 70710-1839-1; 70710-1839-8 | Failed Impurities/Degradation Specifications | Zydus Pharmaceuticals (USA) Inc / 1,893 vials | Class II | Ongoing |
| D-0247-2025 | 02-12-2025 | ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Medical Instrument Factory Co., Ltd., Made in China, Manufactured for: Rece International Corp., Miami Lakes, FL, 33014, USA, NDC: 70006-500-01. | Lack of assurance of sterility and cGMP deviations observed at the manufacturing site. | Wuxi Medical lnstrument Factory Co., Ltd. / 37,500 Boxes | Class II | Ongoing |
| D-0257-2025 | 02-10-2025 | Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50 | Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port. | Nephron Sterile Compounding Center LLC / 4,190 bottles | Class II | Terminated |
| D-0265-2025 | 02-07-2025 | Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping. | CGMP Deviations | Aspen Biopharma Labs Pvt., Ltd. / 4.0 kg | Class II | Ongoing |
| D-0261-2025 | 02-07-2025 | Alprostadil Container Description: Amber color bottle | CGMP Deviations | Aspen Biopharma Labs Pvt., Ltd. / 3.0 gm | Class II | Ongoing |
| D-0263-2025 | 02-07-2025 | Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping. | CGMP Deviations | Aspen Biopharma Labs Pvt., Ltd. / 5.1 kg | Class II | Ongoing |
| D-0264-2025 | 02-07-2025 | Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle | CGMP Deviations | Aspen Biopharma Labs Pvt., Ltd. / 150.0 gm | Class II | Ongoing |
| D-0262-2025 | 02-07-2025 | Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping. | CGMP Deviations | Aspen Biopharma Labs Pvt., Ltd. / 120.0 kg | Class II | Ongoing |
| D-0260-2025 | 02-07-2025 | Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping. | CGMP Deviations | Aspen Biopharma Labs Pvt., Ltd. / 400.0 gm | Class II | Ongoing |
| D-0249-2025 | 02-06-2025 | Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 63304-452-01 Package NDCs: 63304-450-03; 63304-450-01; 63304-450-05; 63304-451-03; 63304-451-01; 63304-451-05; 63304-758-03; 63304-758-01; 63304-758-05; 63304-758-50; 63304-452-03; 63304-452-01; 63304-452-05; 63304-453-03; 63304-453-01; 63304-453-05 | Failed Dissolution Specifications | SUN PHARMACEUTICAL INDUSTRIES INC / 9840 bottles | Class II | Ongoing |
| D-0246-2025 | 02-06-2025 | Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30 | Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product. | Padagis US LLC / 4944 cartons | Class II | Completed |
| D-0229-2025 | 02-04-2025 | Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals of NY, LLC, NY 11719, NDC 42291-778-90 Package NDCs: 42291-777-30; 42291-778-90 | Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%) | AvKARE / 1266 bottles | Class II | Ongoing |
| D-0225-2025 | 01-31-2025 | fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01 | Lack of Assurance of Sterility | Fagron Compounding Services / 1330 bags | Class II | Completed |
| D-0245-2025 | 01-31-2025 | Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packaged in 5-count carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058, Manufactured by: Kindeva Drug Delivery L/P, Northridge, CA 91324, NDC 47781-424-47. Package NDCs: 47781-423-11; 47781-423-47; 47781-424-11; 47781-424-47; 47781-426-11; 47781-426-47; 47781-427-11; 47781-427-47; 47781-428-11; 47781-428-47 | Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch. | Alvogen, Inc / 112,128 cartons (5 pouches/carton) | Class I | Ongoing |
| D-0364-2025 | 01-31-2025 | CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05. | Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle | Direct Rx / 477 bottles. | Class II | Ongoing |
| D-0221-2025 | 01-30-2025 | Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. Made in India. Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152. NDC: 0904-7216-61 Package NDCs: 0904-7216-61 | Failed Dissolution Specifications. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 6997 cartons | Class II | Ongoing |
| D-0244-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01. Package NDCs: 16714-755-01; 16714-756-01; 16714-757-01; 16714-758-01; 16714-759-01; 16714-760-01; 16714-761-01 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 58,368 bottles | Class II | Ongoing |
| D-0237-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30. Package NDCs: 68462-265-30; 68462-265-23; 68462-266-30; 68462-266-23; 68462-267-30; 68462-267-23; 68462-268-30; 68462-268-23; 68462-269-30; 68462-269-23; 68462-270-30; 68462-270-23; 68462-271-30; 68462-271-51 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 39,168 bottles | Class II | Ongoing |
| D-0243-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01. Package NDCs: 16714-755-01; 16714-756-01; 16714-757-01; 16714-758-01; 16714-759-01; 16714-760-01; 16714-761-01 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 58,416 bottles | Class II | Ongoing |
| D-0231-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30. Package NDCs: 68462-265-30; 68462-265-23; 68462-266-30; 68462-266-23; 68462-267-30; 68462-267-23; 68462-268-30; 68462-268-23; 68462-269-30; 68462-269-23; 68462-270-30; 68462-270-23; 68462-271-30; 68462-271-51 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 70,032 bottles | Class II | Ongoing |
| D-0234-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30. Package NDCs: 68462-265-30; 68462-265-23; 68462-266-30; 68462-266-23; 68462-267-30; 68462-267-23; 68462-268-30; 68462-268-23; 68462-269-30; 68462-269-23; 68462-270-30; 68462-270-23; 68462-271-30; 68462-271-51 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 190,320 bottles | Class II | Ongoing |
| D-0233-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30. Package NDCs: 68462-265-30; 68462-265-23; 68462-266-30; 68462-266-23; 68462-267-30; 68462-267-23; 68462-268-30; 68462-268-23; 68462-269-30; 68462-269-23; 68462-270-30; 68462-270-23; 68462-271-30; 68462-271-51 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 175,920 bottles | Class II | Ongoing |
| D-0236-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30. Package NDCs: 68462-265-30; 68462-265-23; 68462-266-30; 68462-266-23; 68462-267-30; 68462-267-23; 68462-268-30; 68462-268-23; 68462-269-30; 68462-269-23; 68462-270-30; 68462-270-23; 68462-271-30; 68462-271-51 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 87,600 bottles | Class II | Ongoing |
| D-0235-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30. Package NDCs: 68462-265-30; 68462-265-23; 68462-266-30; 68462-266-23; 68462-267-30; 68462-267-23; 68462-268-30; 68462-268-23; 68462-269-30; 68462-269-23; 68462-270-30; 68462-270-23; 68462-271-30; 68462-271-51 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 80,160 bottles | Class II | Ongoing |
| D-0232-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30. Package NDCs: 68462-265-30; 68462-265-23; 68462-266-30; 68462-266-23; 68462-267-30; 68462-267-23; 68462-268-30; 68462-268-23; 68462-269-30; 68462-269-23; 68462-270-30; 68462-270-23; 68462-271-30; 68462-271-51 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 56,208 bottles | Class II | Ongoing |
| D-0238-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01. Package NDCs: 16714-755-01; 16714-756-01; 16714-757-01; 16714-758-01; 16714-759-01; 16714-760-01; 16714-761-01 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 120,000 bottles | Class II | Ongoing |
| D-0241-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01. Package NDCs: 16714-755-01; 16714-756-01; 16714-757-01; 16714-758-01; 16714-759-01; 16714-760-01; 16714-761-01 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 233,040 bottles | Class II | Ongoing |
| D-0242-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01. Package NDCs: 16714-755-01; 16714-756-01; 16714-757-01; 16714-758-01; 16714-759-01; 16714-760-01; 16714-761-01 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 53,952 bottles | Class II | Ongoing |
| D-0239-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01. Package NDCs: 16714-755-01; 16714-756-01; 16714-757-01; 16714-758-01; 16714-759-01; 16714-760-01; 16714-761-01 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 119,040 bottles | Class II | Ongoing |
| D-0240-2025 | 01-29-2025 | Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01. Package NDCs: 16714-755-01; 16714-756-01; 16714-757-01; 16714-758-01; 16714-759-01; 16714-760-01; 16714-761-01 | CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / 133,824 bottles | Class II | Ongoing |
| D-0301-2025 | 01-28-2025 | SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00102 7 | Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus | Ascent Consumer Products Inc. / unknown | Class I | Ongoing |
| D-0299-2025 | 01-28-2025 | SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00104 1 | Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus | Ascent Consumer Products Inc. / 4,176 cartons | Class I | Ongoing |
| D-0300-2025 | 01-28-2025 | SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Natural USP Grade Saline Packets, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00103 4 | Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus | Ascent Consumer Products Inc. / unknown | Class I | Ongoing |
| D-0217-2025 | 01-24-2025 | Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00. | CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit. | RemedyRepack Inc. / 247 blister packs | Class II | Terminated |
| D-0220-2025 | 01-24-2025 | HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-328-10 | Failed Impurities/Degradation Specifications | SKY PACKAGING / | Class II | Ongoing |
| D-0219-2025 | 01-24-2025 | HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-327-10 | Failed Impurities/Degradation Specifications | SKY PACKAGING / | Class II | Ongoing |
| D-0214-2025 | 01-23-2025 | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05. Package NDCs: 64980-513-05; 64980-513-01; 64980-513-15; 64980-514-05; 64980-514-01; 64980-514-15 | Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. | FDC Limited / 118104 bottles | Class II | Ongoing |
| D-0215-2025 | 01-22-2025 | Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ. Package NDCs: 68462-162-60; 68462-162-01; 68462-162-18; 68462-162-05; 68462-162-10; 68462-163-60; 68462-163-01; 68462-163-18; 68462-163-05; 68462-163-10; 68462-164-60; 68462-164-01; 68462-164-18; 68462-164-05; 68462-164-10; 68462-165-60; 68462-165-01; 68462-165-18; 68462-165-05; 68462-165-10 | CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / | Class II | Ongoing |
| D-0216-2025 | 01-22-2025 | Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ. Package NDCs: 68462-162-60; 68462-162-01; 68462-162-18; 68462-162-05; 68462-162-10; 68462-163-60; 68462-163-01; 68462-163-18; 68462-163-05; 68462-163-10; 68462-164-60; 68462-164-01; 68462-164-18; 68462-164-05; 68462-164-10; 68462-165-60; 68462-165-01; 68462-165-18; 68462-165-05; 68462-165-10 | CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit. | Glenmark Pharmaceuticals Inc., USA / | Class II | Ongoing |
| D-0224-2025 | 01-21-2025 | Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15 Package NDCs: 50268-440-11; 50268-440-15; 50268-441-11; 50268-441-15; 50268-442-11; 50268-442-15 | Out of Specification for Dissolution | AvKARE / 341 cartons | Class II | Ongoing |
| D-0230-2025 | 01-21-2025 | Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Pharmacy Bulk Package (supplied as a single unit), Dist. by: Provepharm, Inc., Collegeville, PA 19426 | Presence of Particulate Matter. | Provepharm Inc. / 24640 vials | Class I | Ongoing |
| D-0226-2025 | 01-21-2025 | Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6007-61 Package NDCs: 0904-6007-60; 0904-6007-61; 0904-6008-60; 0904-6008-61; 0904-6009-60; 0904-6009-61 | Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 82,281 cartons | Class II | Ongoing |
| D-0227-2025 | 01-21-2025 | Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6008-61. Package NDCs: 0904-6007-60; 0904-6007-61; 0904-6008-60; 0904-6008-61; 0904-6009-60; 0904-6009-61 | Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 94,349 cartons | Class II | Ongoing |
| D-0228-2025 | 01-21-2025 | Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6009-61. Package NDCs: 0904-6007-60; 0904-6007-61; 0904-6008-60; 0904-6008-61; 0904-6009-60; 0904-6009-61 | Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 27,525 cartons | Class II | Ongoing |
| D-0209-2025 | 01-17-2025 | BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc oxide), 2.4 oz., Tin, W.S. Badger Company, Inc, 768 Route 10, Gilsum NH, 03448 UPC 6 34084 47150 2 | Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use. | The W.S. Badger Company, Inc. / 4,834 tins | Class III | Terminated |
| D-0213-2025 | 01-17-2025 | Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01 Package NDCs: 0069-0809-01 | cGMP Deviations: Product intended for quarantine was inadvertently distributed. | McKesson / 192 vials | Class II | Ongoing |
| D-0208-2025 | 01-16-2025 | Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90. Package NDCs: 43598-943-30; 43598-943-90; 43598-944-30; 43598-944-90 | Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet | Appco Pharma LLC / 1380 bottles | Class III | Completed |
| D-0212-2025 | 01-13-2025 | Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA. | CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / a) 6408 boxes and b)1488 boxes | Class II | Terminated |
| D-0218-2025 | 01-10-2025 | Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459-910-15, Blister NDC 63459-910-12; (c) 1 syringe in 1 CARTON, NDC 63459-910-17 without safety guard and blister, Rx Only, Manufactured by: UAB Teva Baltics, Vilnius, Lithuania. Distributed by Teva Pharmaceuticals USA, Inc. North Wales PA 19454. Product of Israel. Package NDCs: 63459-910-01; 63459-910-12; 63459-910-11; 63459-910-15; 63459-910-18; 63459-910-17; 63459-910-36; 63459-912-01; 63459-912-12; 63459-912-11; 63459-912-15; 63459-912-18; 63459-912-17; 63459-912-36; 63459-918-53; 63459-918-59; 63459-920-53; 63459-920-59 | Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit | Teva Pharmaceuticals USA, Inc / 34,636 cartons | Class II | Ongoing |
| D-0298-2025 | 01-08-2025 | babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada. | Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed. | Johnson, S C and Son, Inc / 57,184 bottles | Class II | Ongoing |
| D-0201-2025 | 01-07-2025 | Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-11 Package NDCs: 60687-423-11; 60687-423-21 | Presence of Foreign Tablets/Capsules | Amerisource Health Services LLC / 4640 units | Class II | Ongoing |
| D-0222-2025 | 01-07-2025 | Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-16 Package NDCs: 0121-0775-04; 0121-0775-08; 0121-0775-16; 0121-1775-05; 0121-1775-00; 0121-1775-10; 0121-1775-40; 0121-1550-10; 0121-1550-00; 0121-1550-40 | Superpotent; sodium benzoate preservative | PAI Holdings, LLC. dba Pharmaceutical Associates Inc / 4080 Bottles | Class III | Terminated |
| D-0189-2025 | 12-30-2024 | Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60 | CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. | Rising Pharma Holding, Inc. / 73,680 bottles | Class II | Ongoing |
| D-0192-2025 | 12-30-2024 | Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayman Islands, NDC 82009-117-10 Package NDCs: 82009-117-10; 82009-118-01 | Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg. | Granules Pharmaceuticals Inc. / 6,804 bottles | Class II | Terminated |
