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TradepilotUSA Recalls

drug — TradePilot Recalls

Official product recall notices and clearly labeled enforcement reference records.

Reference notice · drug

Sterling Pharmaceutical Services LLC — Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-

Lack of Assurance of Sterility

Dupo, IL, US · Updated 9/30/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

Sterling Pharmaceutical Services LLC — Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, www.reliable1labs.com, NDC 696

Lack of Assurance of Sterility

Dupo, IL, US · Updated 9/30/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company — Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) , 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech

Lack of Assurance of Sterility

Tarrytown, NY, US · Updated 9/30/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

Sterling Pharmaceutical Services LLC — AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) bottle, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-15

Lack of Assurance of Sterility

Dupo, IL, US · Updated 9/30/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

Sterling Pharmaceutical Services LLC — Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 FL OZ (15 mL) bottles, Distributed by Cameron Pharmaceuticals, LLC, Louisville,

Lack of Assurance of Sterility

Dupo, IL, US · Updated 9/30/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

Sterling Pharmaceutical Services LLC — Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant Eye Drops, Sterile, 0.5 OZ (15 mL) bottles, Distributed by Walgreen Co., 200 Wilmot Rd., Deerfield, IL

Lack of Assurance of Sterility

Dupo, IL, US · Updated 9/30/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

Sterling Pharmaceutical Services LLC — Walgreens Lubricant Eye Drops, 0.5 FL OZ (15 mL) 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by Walgreens Co., 200 Wilmot Road, Deerfield, IL 60015, NDC 0363-8833-15.

Lack of Assurance of Sterility

Dupo, IL, US · Updated 9/30/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

Macleods Pharmaceuticals Limited — Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Him

Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.

Tehsil Baddi, District Solan, US · Updated 9/30/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

Sterling Pharmaceutical Services LLC — TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 FL OZ (15 mL) bottles, Manufactured exclusively for TRP Company

Lack of Assurance of Sterility

Dupo, IL, US · Updated 9/30/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company — Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with Hang Tag, 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist

Lack of Assurance of Sterility

Tarrytown, NY, US · Updated 9/30/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

Sterling Pharmaceutical Services LLC — AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) EACH, 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by: AVK

Lack of Assurance of Sterility

Dupo, IL, US · Updated 9/30/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

Amneal Pharmaceuticals of New York, LLC — Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahme

Defective Delivery System: Possibility of no medication in the prefilled pen.

Brookhaven, NY, US · Updated 9/30/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

Sterling Pharmaceutical Services LLC — Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY,

Lack of Assurance of Sterility

Dupo, IL, US · Updated 9/30/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

Inventia Healthcare Limited — Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC: 64980-599-01

Failed Dissolution Specifications

Kalyan, N/A, US · Updated 9/23/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

SUN PHARMACEUTICAL INDUSTRIES INC — Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761; Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 105

Failed Stability Specifications

Princeton, NJ, US · Updated 9/23/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

Safecor Health, LLC — Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 0

Failed Stability Specifications

Woburn, MA, US · Updated 9/23/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

Safecor Health, LLC — Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 0

Failed Stability Specifications

Woburn, MA, US · Updated 9/23/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

Pfizer — Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Vial NDC 0409-5820-11, Carton

Lack of Assurance of Sterility

Manhattan, NY, US · Updated 9/23/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

Safecor Health, LLC — Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 0

Failed Stability Specifications

Woburn, MA, US · Updated 9/23/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

Safecor Health, LLC — Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00

Failed Stability Specifications

Woburn, MA, US · Updated 9/23/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

SUN PHARMA /TARO — Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada, Dist By: Taro Pharmaceuticals U.S.A. Inc. Haw

Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).

Hawthorne, NY, US · Updated 9/23/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

Safecor Health, LLC — Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 0

Failed Stability Specifications

Woburn, MA, US · Updated 9/23/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

Safecor Health, LLC — Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 0

Failed Stability Specifications

Woburn, MA, US · Updated 9/23/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

American Regent, Inc. — Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY

Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.

Shirley, NY, US · Updated 9/16/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

Baxter Healthcare Corporation — Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06

Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.

Deerfield, IL, US · Updated 9/16/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

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