FDA Recalls and Warnings: Amazon Acetaminophen, Millions of Eye Drops and More Compounded Glutathione

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<p>Welcome to the FDA Recalls and Warnings Update, a series dedicated to keeping you informed about the latest medication recalls, manufacturing violations, and quality concerns affecting your prescriptions. In this installment, we’re highlighting drug recalls for Amazon Acetaminophen Extra Strength Caplets, Benzoyl Peroxide Wash, Clindamycin Phosphate Foam, Compounded Glutathione, Estradiol Gel, FOCUS PI Eye Drops, Omni Gold Anti-Marks Cream, Orbi 20 Whitening Cream, and Paxil CR.</p>
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<p>Unless otherwise specified, all of the recalls are for products that were distributed nationwide. Consumers may wish to check the linked enforcement report for the list of affected product lot numbers and expiration dates. For prescription drugs that don’t include a lot number on the packaging, consumers may check with their pharmacist to see whether a medication is affected by the recall. </p>
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<h2 class="wp-block-heading">How To Read This Report</h2>
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<p>The Food and Drug Administration (FDA) categorizes product recalls in its Enforcement Report database based on the level of health risk, labeling them as Class I, II, III, or "not yet classified."</p>
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<p>While the database includes drugs, food, cosmetics, medical devices, biologics, tobacco, and veterinary products, this report only covers selected drug recalls.</p>
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<li>Class I recalls are the most serious. In these situations, there is "reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death."</li>
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<li>Class II recalls are for drugs that may cause temporary or medically reversible adverse health consequences or where use of the product is unlikely to result in serious adverse health consequences.</li>
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<li>Class III recalls are the least serious. Use of the product is not likely to cause adverse health consequences.</li>
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<p>Drug manufacturers, supplement companies, and medical device makers may receive a Warning Letter from the FDA if they commit serious violations of federal regulations. This letter comes from an overseeing FDA office, such as the Center for Drug Evaluation and Research. Common violations include poor manufacturing practices, false product claims, selling misbranded items, or marketing unapproved products. The letter gives the recipient a chance to correct the issues and requires a response, usually within 15 days.</p>
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<p>FDA Import Alerts notify field staff and the public when the agency has enough evidence to detain products without physical examination (DWPE) due to suspected violations of <a href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211">FDA laws</a>, including violations of “current good manufacturing practices for finished pharmaceuticals” or <a href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-99">unapproved new drugs</a>. The violations lists are arranged by type of violation, then by country and then by the importing company. In some cases, Import Alerts may be linked to Warning Letters for issues like manufacturing violations.</p>
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<h2 class="wp-block-heading">Drug Recalls</h2>
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<h3 class="wp-block-heading">Amazon Acetaminophen Extra Strength Caplets</h3>
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<p><strong>Company</strong>: Aurobindo Pharma USA Inc.; distributed by Amazon.com Services LLC, Seattle, Washington<br><strong>Manufacturing Location</strong>: India by APL (Aurobindo Pharma Limited)<br><strong>Scope</strong>: 14,640 200-count bottles of 500 mg caplets; 90,456 500-count bottles of 500 mg caplets; 7,836 500-count bottles of 500 mg caplets<br><strong>Drug Purpose</strong>: Over-the-counter pain reliever and fever reducer used for temporary relief of minor aches and pains.<br><strong>Recall Reason</strong>: Consumer complaints were received regarding discolored tablets<br><strong>Recall Initiation Date</strong>: September 18, 2026<br><strong>Recall Level</strong>: Not yet classified<br><strong>Essential Extras</strong>: A manufacturing facility in Jedcherla, Telangana, India, of Aurobindo Pharma Limited (APL) was inspected from January 28 to February 10, 2026, and received a <a href="https://www.fda.gov/media/191198/download">Form 483 inspection</a> report detailing observations about cleaning deficiencies and manufacturing violations. However, it is unknown whether this is the facility that manufactured the acetaminophen caplets identified in this recall. The manufacturing company name was obtained from the product <a href="https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=10ee2f40-858d-bed4-e063-6394a90a86bb">drug label</a>.<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99934">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Benzoyl Peroxide Wash</h3>
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<p><strong>Company</strong>: SV Labs Toronto Corporation<br><strong>Manufacturing Location</strong>: Canada; distributed by Rugby Laboratories, Livonia Michigan<br><strong>Scope</strong>: Unspecified quantity of 5% 5 fl oz (148 mL) bottles; Unspecified quantity of 10%, 5 FL OZ (148mL) bottles and 10% 8.5 fl oz (237 mL) bottles. This recall is limited to Illinois.<br><strong>Drug Purpose</strong>: Over-the-counter topical medication skin wash used to treat acne<br><strong>Recall Reason</strong>: Microbial contamination<br><strong>Recall Initiation Date</strong>: September 1, 2026<br><strong>Recall Level</strong>: Class II<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99866">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Clindamycin Phosphate Foam</h3>
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<p><strong>Company</strong>: Glenmark Pharmaceuticals Inc., USA<br><strong>Manufacturing Location</strong>: Italy<br><strong>Scope</strong>: 2,808 cans (100 g), 1% strength for topical use only<br><strong>Drug Purpose</strong>: Prescription topical antibiotic used to treat acne in people aged 12 years and older.<br><strong>Recall Reason</strong>: Defective container. The firm received customer complaints of damaged and leaking cans.<br><strong>Recall Initiation Date</strong>: September 10, 2026<br><strong>Recall Level</strong>: Not yet classified<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99862">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Compounded Glutathione </h3>
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<p><strong>Company</strong>: Greenwich Rx Compounding Pharmacy<br><strong>Manufacturing Location</strong>: Tomball, Texas <br><strong>Scope</strong>: 10 lots of compounded glutathione, 200 mg/mL, dispensed in 10mL multidose vials and intended for subcutaneous injection. The recalled products were distributed to people nationwide between June 26, 2026, and September 21, 2026.<br><strong>Drug Purpose</strong>: Compounded injectable glutathione is a peptide therapy marketed to help combat cellular damage, support the immune system, and support liver detoxification.<br><strong>Recall Reason</strong>: Potential elevated endotoxin levels. Injectable products with elevated endotoxin may cause serious reactions including fever, low blood pressure, inflammatory reactions, anaphylactic shock, or death.<br><strong>Recall Initiation Date</strong>: October 1, 2026<br><strong>Recall Level</strong>: Not yet classified, but will likely be classified as a Class I recall based on the severity of health risk.<br><strong>Essential Extras</strong>: In a press release, Greenwich Rx said it received two reports of people requiring emergency department care after receiving a glutathione product intravenously that was not formulated for IV use. The company is notifying customers by mail of the voluntary recall. Anyone who received glutathione from one of the affected lots should stop using it and follow Greenwich Rx's disposal instructions.</p>
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<p>In July and August 2026, two other Texas pharmacies, Optimal Balance Pharmacy (Houston) and Victory Medical Center Pharmacy (Austin), initiated <a href="https://medshadow.org/drug-updates-recalls/fda-recalls-and-warnings/glutathione-peptide-injections-recalled-endotoxin-contamination/">similar recalls</a> for glutathione products. Centric Compounding (Houston), issued a <a href="https://medshadow.org/drug-updates-recalls/fda-recalls-and-warnings/third-glutathione-injection-recall-endotoxin-contamination/">similar recall</a> in September 2026. The active ingredient suppliers to these compounding pharmacies have not been specified. <a href="https://www.fda.gov/drugs/human-drug-compounding/fda-compounders-know-your-bulks-and-excipients-suppliers">FDA Guidance to Compounders</a> was released in February 2026, advising compounders to ensure their suppliers test ingredients and properly label them to certify quality and appropriate use.<br><strong>Link</strong>: <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/greenwich-rx-issues-voluntary-nationwide-recall-compounded-glutathione-due-elevated-endotoxin-levels">FDA Press Release</a> and <a href="https://greenwichrx.org/news/glutathione-recall-2026-10">Greenwich Rx Press Release</a> </p>
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<h3 class="wp-block-heading">Estradiol Gel, 0.1% </h3>
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<p><strong>Company</strong>: Amneal Pharmaceuticals, LLC<br><strong>Manufacturing Location</strong>: Not specified; distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ<br><strong>Scope</strong>: 2,592 30-count cartons of 0.1%, 0.25 mg single-dose packets<br><strong>Drug Purpose</strong>: Transdermal estrogen therapy used to treat vasomotor symptoms of menopause, such as hot flashes. Each foil packet contains a single daily dose for application to the upper thigh.<br><strong>Recall Reason</strong>: Defective container. Packets were found to be empty or only partially filled.<br><strong>Recall Level</strong>: Class II<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99742">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">FOCUS PI Hypromellose 0.7% Formula</h3>
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<p><strong>Company</strong>: Aurolab Trust<br><strong>Manufacturing Location</strong>: Madurai,, India by Aurolab Trust for Covalent Management, Inc., Manassas, Virginia<br><strong>Scope</strong>: 25,220 0.3 fl oz (10 mL) bottles distributed in Virginia.<br><strong>Drug Purpose</strong>: Over-the-counter lubricating eye drops used to relieve dry-eye symptoms and help prevent further eye irritation.<br><strong>Recall Reason</strong>: Lack of assurance of sterility<br><strong>Recall Initiation Date</strong>: September 17, 2026<br><strong>Recall Leve</strong>l: Class II<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99903">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Orbi 20 Whitening Cream and Omni Gold Anti-Marks Cream</h3>
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<p><strong>Company</strong>: Danalvig LLC, Lincoln, Nebraska<br><strong>Manufacturing Location</strong>: Lahore, Pakistan by White Gold International<br><strong>Scope</strong>: 17 containers of Orbi 20 Whitening Cream and 17 containers of Omni Gold Anti-Marks Cream distributed nationwide by Ebay<br><strong>Drug Purpose</strong>: Skin cream marketed to lighten and brighten skin<br><strong>Recall Reason</strong>: Products are not approved or allowed to be sold in the U.S. because the products do not meet United States Pharmacopeia (USP) or over-the-counter (OTC) monograph requirements. FDA laboratory analysis found the product to be contaminated with mercury. Mercury-containing skin creams can cause serious health effects.<br><strong>Recall Initiation Date</strong>: June 15, 2026<br><strong>Recall Level</strong>: Not yet classified<br><strong>Essential Extras</strong>: Since 2019, the FDA has tested many skin-lightening products and found mercury and/or hydroquinone, an ingredient now available only by prescription. FDA issued a series of “<a href="https://www.fda.gov/consumers/health-fraud-scams/skin-facts-what-you-need-know-about-skin-lightening-products">skin facts</a>” alerts to notify consumers about potentially harmful over-the-counter (OTC) skin products containing hydroquinone or mercury. Consumers can find these products online and in retail stores. </p>
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<p>Check the <a href="https://www.fda.gov/consumers/health-fraud-scams/fda-warns-consumers-skin-products-containing-mercury-andor-hydroquinone">FDA Press release</a> for a list of newly identified skin-lightening products and test results for mercury and hydroquinone concentrations. Orbi 20 Whitening Cream, one of the products in this recall, tested at 27,762 ppm of mercury. Omni Gold Anti-Marks Cream Extra Brightening contained 12,227 ppm of mercury.<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99857">FDA Enforcement Report</a> and <a href="https://www.fda.gov/consumers/health-fraud-scams/fda-warns-consumers-skin-products-containing-mercury-andor-hydroquinone">FDA Press Release</a></p>
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<h3 class="wp-block-heading">Paxil CR (Paroxetine) Extended-Release Tablets</h3>
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<p><strong>Company</strong>: Apotex Corp.<br><strong>Manufacturing Location</strong>: Toronto, Ontario, Canada by Apotex Inc.<br><strong>Scope</strong>: Unspecified quantity of 30-count bottles of 37.5 mg, extended-release tablets<br><strong>Drug Purpose</strong>: Treats depression, panic disorder, social anxiety disorder, and premenstrual dysphoric disorder. This medication is a selective serotonin reuptake inhibitor (SSRI).<br><strong>Recall Reason</strong>: Failed dissolution specifications; the tablets may not dissolve as intended, potentially reducing drug effectiveness.<br><strong>Recall Initiation Date</strong>: September 23, 2026<br><strong>Recall Level</strong>: Class II<br><strong>Essential Extras</strong>: Apotex issued a <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99673">similar recall</a> in August 2026 for 6,972 bottles of Paxil CR 37.5 mg <strong>extended</strong>-release tablets.<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99978">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">K.C. Pharma’s Artificial Tears Sterile Lubricant Eye Drops, Sterile Eye Drops AC, Sterile Eye Drops Advanced Relief, Eye Drops Maximum Redness Relief, Sterile Lubricant Dry Eye Relief Eye Drops, Sterile Eye Drops Original, Sterile Eye Drops Redness Relief, Sterile High Performance Ultra Lubricating Eye Drops (various store and private label brand names)</h3>
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<p><strong>Company</strong>: K.C. Pharmaceuticals, Inc.<br><strong>Manufacturing Location</strong>: Pomona, California<br><strong>Scope</strong>: 4,848,342 bottles containing 0.5 fluid ounces (15 mL) with expiration dates between 11/30/2026 and 11/30/2027, distributed nationwide under these store-brand and private labels:<br><br>Best Choice, Colirio, Crocodile Tears, Discount Drug Mart, Equaline, Equate (Walmart), Exchange Select, Foster & Thrive, Geri Care, Good Neighbor Pharmacy, Good Sense, Harris Teeter, H-E-B, Kroger, Leader (Cardinal Health), Lil' DrugStore, Medic’s Choice, Publix, QC-Quality Choice, Rite Aid, Rugby, TopCare, Tyson Mike, Up & Up (Target), Walgreens, Xpect. Quantity was not specified for the Sterile Eye Drops Redness Relief product.<br><br><strong>Drug Purpose</strong>: Eye drops to relieve dry eye and redness and provide lubrication.<br><strong>Recall Reason</strong>: Lack of assurance of sterility; the products may not have been manufactured under proper sterile conditions<br><strong>Recall Initiation Date</strong>: September 11, 2026<br><strong>Recall Level</strong>: Class II<br><strong>Essential Extras</strong>: On August 12, 2026, K.C. Pharmaceuticals’ Pomona manufacturing facility received an <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kc-pharmaceuticals-inc-729870-08122026">FDA Warning Letter</a> after an inspection uncovered significant violations of Current Good Manufacturing Practice (CGMP) regulations related to the facility’s aseptic and sterilization processes, cleaning and maintenance of equipment, and more. These include repeat violations cited in an August 2023 warning letter. K.C. Pharmaceuticals a<a href="https://www.accessdata.fda.gov/scripts/ires/?Event=98533">lso recalled</a> more than 3 million eye drops in March 2026.<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/?Event=99880">FDA Enforcement Report</a></p>
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