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-0268-2022 | 11-12-2021 | Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets, 20 extended-release tablets, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, NDC 69842-249-20 | Failed dissolution specifications | Dr. Reddy's Laboratories, Inc. / 14976 cartons | Class III | Terminated |
| D-0272-2022 | 11-12-2021 | 12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal Decongestant, 20 Extended-Release Tablets USP, Distributed By Cardinal Health, Dublin, Ohio 43107, Made in India, NDC 70000-0518-1. | Failed dissolution specifications | Dr. Reddy's Laboratories, Inc. / 2496 cartons | Class III | Terminated |
| D-0274-2022 | 11-12-2021 | Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, USP, 30 Extended-Release Tablets USP, Distributed By Walmart Inc., Bentonville, AR 72716, Product of India, NDC 49035-273-30. | Failed dissolution specifications | Dr. Reddy's Laboratories, Inc. / 9,984 cartons | Class III | Terminated |
| D-0270-2022 | 11-12-2021 | Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 20 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0536-1242-34. | Failed dissolution specifications | Dr. Reddy's Laboratories, Inc. / 2352 cartons | Class III | Terminated |
| D-0320-2022 | 11-12-2021 | NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-651-01. | Lack of Assurance of Sterility | SterRx, LLC / 121,584 bags | Class II | Terminated |
| D-0300-2022 | 11-12-2021 | Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave. Plattsburgh, NY 12003, NDC #70324-102-01. | Lack of Assurance of Sterility | SterRx, LLC / 15660 bags | Class II | Terminated |
| D-0302-2022 | 11-12-2021 | dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-976-01. | Lack of Assurance of Sterility | SterRx, LLC / 24300 bags | Class II | Terminated |
| D-0312-2022 | 11-12-2021 | Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-102-02. | Lack of Assurance of Sterility | SterRx, LLC / 36360 bags | Class II | Terminated |
| D-0325-2022 | 11-12-2021 | Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-03 | Lack of Assurance of Sterility | SterRx, LLC / 2886 bags | Class II | Terminated |
| D-0309-2022 | 11-12-2021 | EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-052-01. | Lack of Assurance of Sterility | SterRx, LLC / 7548 bags | Class II | Terminated |
| D-0324-2022 | 11-12-2021 | PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-901-01. | Lack of Assurance of Sterility | SterRx, LLC / 23,136 bags | Class II | Terminated |
| D-0315-2022 | 11-12-2021 | dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-951-01. | Lack of Assurance of Sterility | SterRx, LLC / 8946 bags | Class II | Terminated |
| D-0316-2022 | 11-12-2021 | Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-01. | Lack of Assurance of Sterility | SterRx, LLC / 10660 bags | Class II | Terminated |
| D-0322-2022 | 11-12-2021 | NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Injection, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-926-01. | Lack of Assurance of Sterility | SterRx, LLC / 36,576 bags | Class II | Terminated |
| D-0310-2022 | 11-12-2021 | EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-077-01. | Lack of Assurance of Sterility | SterRx, LLC / 5832 bags | Class II | Terminated |
| D-0311-2022 | 11-12-2021 | EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-627-01. | Lack of Assurance of Sterility | SterRx, LLC / 684 bags | Class II | Terminated |
| D-0304-2022 | 11-12-2021 | EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-027-01. | Lack of Assurance of Sterility | SterRx, LLC / 2779 bags | Class II | Terminated |
| D-0307-2022 | 11-12-2021 | Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL, Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-826-01. | Lack of Assurance of Sterility | SterRx, LLC / 3540 bags | Class II | Terminated |
| D-0306-2022 | 11-12-2021 | Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01. | Lack of Assurance of Sterility | SterRx, LLC / 127,260 bags | Class II | Terminated |
| D-0319-2022 | 11-12-2021 | NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-002-01. | Lack of Assurance of Sterility | SterRx, LLC / 1044 bags | Class II | Terminated |
| D-0303-2022 | 11-12-2021 | NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-451-01. | Lack of Assurance of Sterility | SterRx, LLC / 9360 bags | Class II | Terminated |
| D-0313-2022 | 11-12-2021 | Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-452-01. | Lack of Assurance of Sterility | SterRx, LLC / 40 bags | Class II | Terminated |
| D-0318-2022 | 11-12-2021 | MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-427-01. | Lack of Assurance of Sterility | SterRx, LLC / 880 bags | Class II | Terminated |
| D-0321-2022 | 11-12-2021 | NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-676-01. | Lack of Assurance of Sterility | SterRx, LLC / 74,508 bags | Class II | Terminated |
| D-0323-2022 | 11-12-2021 | PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-252-01. | Lack of Assurance of Sterility | SterRx, LLC / 20640 bags | Class II | Terminated |
| D-0317-2022 | 11-12-2021 | Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-02. | Lack of Assurance of Sterility | SterRx, LLC / 5000 bags | Class II | Terminated |
| D-0305-2022 | 11-12-2021 | PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-701-01. | Lack of Assurance of Sterility | SterRx, LLC / 18,948 bags | Class II | Terminated |
| D-0308-2022 | 11-12-2021 | EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-227-01. | Lack of Assurance of Sterility | SterRx, LLC / 26,928 bags | Class II | Terminated |
| D-0301-2022 | 11-12-2021 | Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY, 12903, NDC 70324-427-02. | Lack of Assurance of Sterility | SterRx, LLC / 880 units | Class II | Terminated |
| D-0314-2022 | 11-12-2021 | NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-476-01. | Lack of Assurance of Sterility | SterRx, LLC / 1428 bags | Class II | Terminated |
| D-0087-2024 | 11-09-2021 | Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-05 Package NDCs: 42023-179-05 | Crystallization; identified as Buprenorphine free base | PAR Sterile Products LLC / | Class II | Terminated |
| D-0287-2022 | 11-08-2021 | Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 53329-970-12; b) 8 Oz. (227 g) cans, NDC 53329-970-08; and c) 16 Oz. (453 g) cans, NDC 53329-970-06; Manufactured for: Medline Industries, Inc., Northfield, IL 60093. | Defective Container: Customer complaints for leaking bottles and dispensing issues. | Medline Industries Inc / 470,555 bottles | Class II | Terminated |
| D-0282-2022 | 11-08-2021 | Clindamycin and Benzoyl Peroxide Gel, 1%/5% 25 g jars, Rx only, Mfg by TOLMAR Inc. Fort collins, CO 80526, NDC 0781-7263-68 | Superpotent Drug | TOLMAR, Inc. / | Class II | Terminated |
| D-0233-2022 | 11-04-2021 | Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-704-86 | Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide. | Amneal Pharmaceuticals of New York, LLC / 7,766 bottles | Class II | Terminated |
| D-0234-2022 | 11-04-2021 | Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-703-86 | Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide. | Amneal Pharmaceuticals of New York, LLC / 15,88 bottles | Class II | Terminated |
| D-0229-2022 | 11-03-2021 | Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054 NDC 67877-584-50 Package NDCs: 67877-584-50; 67877-584-01; 67877-584-05; 67877-584-33 | Failed Impurities/Degradation Specifications | Ascend Laboratories LLC / 4104 bottles | Class II | Terminated |
| D-0095-2022 | 11-01-2021 | Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-59), in a) 30-count case (NDC 30-count case: 68094-330-62), and b) 100-count case (NDC 100-count case: 68094-330-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080. Package NDCs: 68094-231-59; 68094-231-62; 68094-231-61; 68094-231-01; 68094-231-58; 68094-330-59; 68094-330-62; 68094-330-61; 68094-030-59; 68094-030-62 | cGMP Deviations: Product manufactured with contaminated raw ingredient. | Precision Dose Inc. / 151,100 unit dose cups | Class II | Terminated |
| D-0094-2022 | 11-01-2021 | Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a) 30-count case (NDC 30-count case: 68094-231-62), and b) 100-count case (NDC 100-count case: 68094-231-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080. Package NDCs: 68094-231-59; 68094-231-62; 68094-231-61; 68094-231-01; 68094-231-58; 68094-330-59; 68094-330-62; 68094-330-61; 68094-030-59; 68094-030-62 | cGMP Deviations: Product manufactured with contaminated raw ingredient. | Precision Dose Inc. / 166,920 unit dose cups | Class II | Terminated |
| D-0235-2022 | 10-28-2021 | Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT Inc., Salt Lake City, UT, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 0591-3508-04 Package NDCs: 0591-3508-54; 0591-3508-04; 0591-3509-54; 0591-3509-04; 0591-3510-54; 0591-3510-04 | Failed Impurities/Degradation Specifications | Teva Pharmaceuticals USA / 64,978 patches | Class III | Terminated |
| D-0277-2022 | 10-28-2021 | VANComycin 1g added to 250mL of 0.9% Sodium Chloride (Injection for Intravenous Use Only), 260 mL per bag, Rx Only, This is a Compounded Drug, Hospital/Office Use Only, Apollo Care 3801 Mojave Ct, Suite 101, Columbia, MO 65202, NDC 71170-254-25 | Crystallization: Product appears to be turbid. | Apollo Care / 225 bags | Class II | Terminated |
| D-0232-2022 | 10-27-2021 | Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx Only, 90 capsules, labelled as (a) Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054; (b) Manufactured By: Actavis Laboratories FL. Inc, Fort Lauderdale FL. 33314 USA, Distributed by Avista Pharma Inc. Parsippany, NJ 07054 USA. NDC 62037-597-90 Package NDCs: 62037-597-90; 62037-597-05; 62037-598-90; 62037-598-05; 62037-599-90; 62037-599-05; 62037-600-90; 62037-600-05 | Labelling: Incorrect Exp. Date | Teva Pharmaceuticals USA / 32316 bottles | Class II | Terminated |
| D-0584-2022 | 10-26-2021 | Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Distributed by Target Corporation, Minneapolis, MN 55403. NDC: 11673-133-16 Package NDCs: 11673-133-16; 11673-133-26 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 22,140 bottles | Class II | Terminated |
| D-0618-2022 | 10-26-2021 | Soothing 12 Hour Nasal Decongestant Spray No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Distributed By MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152. NDC 0904-6761-30 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 41,472 bottles | Class II | Terminated |
| D-0599-2022 | 10-26-2021 | Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), two 4 FL OZ (118 mL) bottles per pack, Distributed by Walmart Inc., Bentonville, AR 72716. NDC: 49035-313-26 Package NDCs: 49035-313-26; 49035-313-34 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 83760 packs | Class II | Terminated |
| D-0580-2022 | 10-26-2021 | Children's Pain & Fever Bubblegum Flavored Acetaminophen Suspension (160mg/5ml), 4 fl oz (118 mL) per bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716. NDC: 49035-313-26 Package NDCs: 49035-313-26; 49035-313-34 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 117552 bottles | Class II | Terminated |
| D-0607-2022 | 10-26-2021 | Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY FOODHOLD U.S.A., LLC, LANDOVER, MD 20785. NDC 41520-108-10 Package NDCs: 41520-108-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 3,192 bottles | Class II | Terminated |
| D-0605-2022 | 10-26-2021 | Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY FOODHOLD U.S.A., LLC, LANDOVER, MD 20785. NDC 41520-108-10 Package NDCs: 41520-108-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 7,200 bottles | Class II | Terminated |
| D-0626-2022 | 10-26-2021 | No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716. NDC 49035-388-10 Package NDCs: 49035-388-10; 49035-388-00; 49035-388-20 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 178,128 bottles | Class II | Terminated |
| D-0589-2022 | 10-26-2021 | Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716. NDC: 49035-959-26 Package NDCs: 49035-959-26; 49035-959-08 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 30,144 bottles | Class II | Terminated |
| D-0629-2022 | 10-26-2021 | Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. NDC 41250-989-10 Package NDCs: 41250-989-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 144 bottles | Class II | Terminated |
| D-0627-2022 | 10-26-2021 | Sinus Severe, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY DOLGENCORP, LLC., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-696-10 Package NDCs: 55910-696-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 79,776 botles | Class II | Terminated |
| D-0586-2022 | 10-26-2021 | Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202. NDC: 30142-818-26 Package NDCs: 30142-818-26 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 3,120 bottles | Class II | Terminated |
| D-0622-2022 | 10-26-2021 | No Drip Nasal Decongestant, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: BETTER LIVING BRANDS LLC, P.O. BOX 99, PLEASANTON, CA 94566-0009. NDC 21130-801-10 Package NDCs: 21130-801-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 11,088 bottles | Class II | Terminated |
| D-0614-2022 | 10-26-2021 | Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: AMAZON.COM SERVICES LLC, 410 TERRY AVENUE N. SEATTLE, WA 9810. NDC 72288-388-10 Package NDCs: 72288-388-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 26,448 bottles | Class II | Terminated |
| D-0628-2022 | 10-26-2021 | Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. NDC 41250-989-10 Package NDCs: 41250-989-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 2,302 bottles | Class II | Terminated |
| D-0594-2022 | 10-26-2021 | Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Target Corporation, Minneapolis, MN 55403. NDC: 11673-759-26 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 14,688 bottles | Class II | Terminated |
| D-0598-2022 | 10-26-2021 | Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716. NDC: 49035-946-16 Package NDCs: 49035-946-10; 49035-946-16 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 68,688 bottles | Class II | Terminated |
| D-0623-2022 | 10-26-2021 | No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA. NDC 41163-703-10 Package NDCs: 41163-703-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 1,560 bottles | Class II | Terminated |
| D-0611-2022 | 10-26-2021 | Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Dist. by Target Corp., Mpls., MN 55403. NDC 11673-935-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 89,208 bottles | Class II | Terminated |
| D-0606-2022 | 10-26-2021 | Severe Congestion No Drip Nasal Spray Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY DOLGENCORP, LLC, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-511-10 Package NDCs: 55910-511-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 21,4824 bottles | Class II | Terminated |
| D-0615-2022 | 10-26-2021 | No Drip Nasal Mist, Oxymetazoline HCl 0.05% Nasal decongestant, 1 FL Oz (30 mL) per bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 59779-388-10 Package NDCs: 59779-388-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 64,512 bottles | Class II | Terminated |
| D-0624-2022 | 10-26-2021 | Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10 Package NDCs: 30142-388-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 36,864 bottles | Class II | Terminated |
| D-0608-2022 | 10-26-2021 | Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011. NDC 11822-6378-1 Package NDCs: 11822-6378-1 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 9,888 bottles | Class II | Terminated |
| D-0619-2022 | 10-26-2021 | Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. NDC 41250-388-10 Package NDCs: 41250-388-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 10,800 bottles | Class II | Terminated |
| D-0601-2022 | 10-26-2021 | Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 11673-105-26 Package NDCs: 11673-105-26; 11673-105-28 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 4,992 bottles | Class II | Terminated |
| D-0613-2022 | 10-26-2021 | Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: AMAZON.COM SERVICES LLC, 410 TERRY AVENUE N. SEATTLE, WA 9810. NDC 72288-388-10 Package NDCs: 72288-388-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 1,296 bottles | Class II | Terminated |
| D-0603-2022 | 10-26-2021 | Maximum Strength Plus Menthol No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: AMAZON.COM SERVICES LLC 410 TERRY AVENUE N.SEATTLE, WA 98109. NDC: 72288-703-10 Package NDCs: 72288-703-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 37,104 bottles | Class II | Terminated |
| D-0620-2022 | 10-26-2021 | Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10 Package NDCs: 30142-388-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 3,744 bottles | Class II | Terminated |
| D-0593-2022 | 10-26-2021 | Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, MADE WITH PRIDE & CARE FOR H-E-B SAN ANTONIO, TX 78204. NDC: 37808-759-26 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 3,840 bottles | Class II | Terminated |
| D-0583-2022 | 10-26-2021 | Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC: 0363-0971-26 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 14,064 bottles | Class II | Terminated |
| D-0782-2022 | 10-26-2021 | artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236 ml) bottles, Dist. By artnaturals, Gardena, CA 90248, UPC: 8 16820 02820 5 | Chemical Contamination: presence of benzene, acetaldehyde, and acetal. | VIRGIN SCENT INC / 47,832 bottles | Class I | Terminated |
| D-0582-2022 | 10-26-2021 | Children's Cherry Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 45802-203-26 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 4,176 bottles | Class II | Terminated |
| D-0587-2022 | 10-26-2021 | Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed By Perrigo, Allegan, MI 49010. NDC: 0113-8959-26 Package NDCs: 0113-8959-26; 0113-8959-34 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 2,832 bottles | Class II | Terminated |
| D-0591-2022 | 10-26-2021 | Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by Target Corp., Minneapolis, MN 55403 NDC: 11673-130-26 Package NDCs: 11673-130-26; 11673-130-28; 11673-130-34 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 26,832 bottles | Class II | Terminated |
| D-0585-2022 | 10-26-2021 | Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC: 59779-946-16 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 37,152 bottles | Class II | Terminated |
| D-0604-2022 | 10-26-2021 | Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Packaged by Perrigo Company for: Big Lots Stores, Inc., P.O. Box 28523, Columbus, OH 43228-0523. NDC: 50594-719-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 3,168 bottles | Class II | Terminated |
| D-0610-2022 | 10-26-2021 | Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA. NDC 41163-343-10 Package NDCs: 41163-343-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 2,664 bottles | Class II | Terminated |
| D-0581-2022 | 10-26-2021 | Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1321-97 Package NDCs: 0536-1321-97 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 4,992 bottles | Class II | Terminated |
| D-0590-2022 | 10-26-2021 | Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY DOLGENCORP, LLC, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC: 55910-251-26 Package NDCs: 55910-251-26; 55910-251-28; 55910-251-34 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 16,992 bottles | Class II | Terminated |
| D-0625-2022 | 10-26-2021 | No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007. NDC 36800-388-10 Package NDCs: 36800-388-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 13,824 bottles | Class II | Terminated |
| D-0612-2022 | 10-26-2021 | Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY TOPCO ASSOCIATES LLC., ELK GROVE VILLAGE, IL 60007. NDC 36800-907-10 Package NDCs: 36800-907-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 19,584 bottles | Class II | Terminated |
| D-0597-2022 | 10-26-2021 | Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentoneville, AR 72716. NDC: 49035-766-16 Package NDCs: 49035-766-16 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 55,656 bottles | Class II | Terminated |
| D-0602-2022 | 10-26-2021 | Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 0113-0020-26 Package NDCs: 0113-0020-26; 0113-0020-28; 0113-0020-34 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 3,024 bottles | Class II | Terminated |
| D-0592-2022 | 10-26-2021 | Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by: Walmart, Inc., Bentonville, AR 72716. NDC: 49035-042-26 Package NDCs: 49035-042-26 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 111,888 bottles | Class II | Terminated |
| D-0783-2022 | 10-26-2021 | artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236 ml) bottles, Dist. By artnaturals, Gardena, CA 90248, UPC: 8 16820 02820 5 | CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot | VIRGIN SCENT INC / 570,268 Bottles | Class II | Terminated |
| D-0784-2022 | 10-26-2021 | artnaturals Hand Sanitizer | CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot | VIRGIN SCENT INC / 46,368 Bottles | Class II | Terminated |
| D-0588-2022 | 10-26-2021 | Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-818-26 Package NDCs: 30142-818-26 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 20,448 bottles | Class II | Terminated |
| D-0596-2022 | 10-26-2021 | Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-766-16 Package NDCs: 30142-766-16 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 5,184 bottles | Class II | Terminated |
| D-0595-2022 | 10-26-2021 | Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-766-16 Package NDCs: 30142-766-16 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 1,296 bottles | Class II | Terminated |
| D-0609-2022 | 10-26-2021 | Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: BETTER LIVING BRANDS LLC, P.O. BOX 99, PLEASANTON, CA 94566-0009. NDC 21130-813-10 Package NDCs: 21130-813-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 14,784 bottles | Class II | Terminated |
| D-0616-2022 | 10-26-2021 | Maxiumum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-623-10 Package NDCs: 55910-623-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 123,408 bottles | Class II | Terminated |
| D-0617-2022 | 10-26-2021 | Nasal Spray Decongestant, No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10 Package NDCs: 30142-388-10 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 7,632 bottles | Class II | Terminated |
| D-0621-2022 | 10-26-2021 | Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011. NDC 11822-6319-1 Package NDCs: 11822-6319-1 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 15,264 bottles | Class II | Terminated |
| D-0579-2022 | 10-26-2021 | Acetaminophen Oral Suspension Grape Flavor, 160 mg per 5 mL, 16 fl oz (473 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 50941-009-43 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 14,868 bottles | Class II | Terminated |
| D-0600-2022 | 10-26-2021 | Children's Pain & Fever Acetaminophen, 160 mg per 5 mL Oral Suspension combo pack. DS SR APAP 160MG CHLD BBGM/DF CHRY/GRP. UPC: 3 70030 11637 9 | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. | Perrigo Company PLC / 561 bottles | Class II | Terminated |
| D-0230-2022 | 10-25-2021 | Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-075-01 Package NDCs: 16714-074-01; 16714-074-02; 16714-075-01; 16714-076-01; 16714-077-01 | Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product. | SUN PHARMACEUTICAL INDUSTRIES INC / 73,957 30-count bottles | Class II | Terminated |
| D-0231-2022 | 10-25-2021 | Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-077-01 Package NDCs: 16714-074-01; 16714-074-02; 16714-075-01; 16714-076-01; 16714-077-01 | Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product. | SUN PHARMACEUTICAL INDUSTRIES INC / 36,786 30-count bottles | Class II | Terminated |
| D-0255-2022 | 10-25-2021 | Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: Unichem Laboratories LTD, Ind. Area. Meerut Road, Ghaziabad -201 003, India. Manufactured for: Unichem Pharmaceuticals (USA), Inc., East Brunswick, NJ 06815, NDC 29300-116-05. Package NDCs: 29300-115-16; 29300-115-01; 29300-115-05; 29300-115-10; 29300-116-16; 29300-116-01; 29300-116-05; 29300-116-10; 29300-117-16; 29300-117-01; 29300-117-05; 29300-117-10; 29300-118-16; 29300-118-01; 29300-118-05; 29300-118-10 | Discoloration | UNICHEM PHARMACEUTICALS USA INC / 1284 bottles | Class III | Terminated |
| D-0361-2022 | 10-22-2021 | Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15 Dadra-396 191, (U.T. of D & NH), India, NDC 47335-687-88. Package NDCs: 47335-686-83; 47335-686-88; 47335-686-08; 47335-686-18; 47335-687-83; 47335-687-88; 47335-687-08; 47335-687-18; 47335-688-83; 47335-688-88; 47335-688-08; 47335-688-18; 47335-689-83; 47335-689-88; 47335-689-08; 47335-689-18; 47335-690-83; 47335-690-88; 47335-690-08; 47335-690-18; 47335-691-83; 47335-691-88; 47335-691-08; 47335-691-18; 47335-692-83; 47335-692-88; 47335-692-08; 47335-692-18; 47335-693-83; 47335-693-88; 47335-693-08; 47335-693-18 | Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient. | SUN PHARMACEUTICAL INDUSTRIES INC / 696 Bottles | Class II | Terminated |
| D-0091-2022 | 10-20-2021 | Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01. | Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration. | Lupin Pharmaceuticals Inc. / 16,272 bottles | Class III | Terminated |
