FDA Recalls and Warnings: Potentially Contaminated Cough Drops and Eye Drops, Subpotent Thyroid Medications & More

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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 recalls for K.C. Pharma’s store-brand eye drops, Bromfenac, Isotretinoin, Levothyroxine, Prazosin, Tramadol, Xanax XR, and five private-label brands of cough drops.</p>
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<p>All of the recalls in this installment have been assigned a “Class II” level by the FDA. These are supplier-level recalls and not directed at consumers. However, consumers may wish to check the linked enforcement report for the list of affected product lot numbers and expiration dates.</p>
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<h2 class="wp-block-heading has-text-align-center">How to Read This Report</h2>
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<h3 class="wp-block-accordion-heading"><button type="button" class="wp-block-accordion-heading__toggle"><span class="wp-block-accordion-heading__toggle-title">Recalls (Enforcement Reports Database)</span><span class="wp-block-accordion-heading__toggle-icon" aria-hidden="true">+</span></button></h3>
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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.<br></p>
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<h3 class="wp-block-accordion-heading"><button type="button" class="wp-block-accordion-heading__toggle"><span class="wp-block-accordion-heading__toggle-title">About the Drug Imports Alerts Database</span><span class="wp-block-accordion-heading__toggle-icon" aria-hidden="true">+</span></button></h3>
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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">Bromfenac Ophthalmic Solution 0.07%</h3>
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<p><strong>Company</strong>: Alembic Pharmaceuticals<br><strong>Manufacturing Location</strong>: Gujarat, India<br><strong>Scope</strong>: Unspecified quantity of 0.07% strength 3 ml bottles; recall is for five lots expiring in March or May of 2026<br><strong>Drug Purpose</strong>: Prescription eye drops treat eye pain and inflammation after cataract surgery<br><strong>Recall Reason</strong>: Failed impurities and degradation specifications when tested at 20 months; this could affect product quality and shelf life<br><strong>Recall Initiation Date</strong>: March 18, 2026<br><br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/?Event=98647">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Cough Drops and Throat Lozenges, Various Private Label Brands</h3>
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<p><strong>Company</strong>: Xiamen Kang Zhongyuan Biotechnology Co., Ltd.<br><strong>Manufacturing Location</strong>: Xiamen, China<br><strong>Scope</strong>: Unspecified quantity of these private-label over-the-counter cough drops and throat lozenges:</p>
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<li>Exchange Select (Manufactured for Your Military Exchanges): Honey Lemon Flavor and Menthol Flavor Cough Drops, 30-count bag</li>
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<li>Caring Mill (distributed by FSA Store, Inc):  Cherry Cough Drops, 90-count bag</li>
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<li>Discount Drug Mart Food Market: Honey Lemon Cough Drops, 30-count bag</li>
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<li>MGC Health (distributed by Medical Group Care): Sugar Free Honey Lemon Cough Drops, 25 and 30-count bag, Honey Lemon Cough Drops, 80-count bag.</li>
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<li>QC Quality Choice (distributed by CDMA, Inc): Black Cherry Sugar Free and regular Cough Drops, 25-count bag, Sugar Free and regular Honey Lemon Cough Drops, 25-count bag; Creamy Strawberry Throat Soothing Drops, 30-count bag, Menthol Cough Drops, 30-count bag, Vanilla Honey Cough Drops, 30-count bag.</li>
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<p><strong>Drug Purpose</strong>: Temporary relief of cough, sore throat, and minor mouth irritation<br><strong>Recall Reason</strong>: FDA recommended this recall based on observations noted during an August 15, 2025, inspection of the manufacturing facility that may affect product quality.<br><strong>Recall Initiation Date</strong>: March 20, 2026<br><strong>Essential Extras</strong>: So far, the FDA has NOT sent a warning letter to Xiamen Kang Zhongyuan Biotechnology Co., Ltd. related to its August 15, 2025 facility inspection.<br><br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98648">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Isotretinoin Capsules</h3>
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<p><strong>Company</strong>: Teva Pharmaceuticals USA, Inc., Parsippany, New Jersey<br><strong>Manufacturing Location</strong>: Not specified<br><strong>Scope</strong>: 21,984 packages of 30 mg strength,10-count prescription packs; 8,376 packages of 40 mg strength, 10-count prescription packs. The recalled medications were distributed in Florida, Ohio, Puerto Rico, and Mississippi.<br><strong>Drug Purpose</strong>: Treats severe cystic acne that has not responded to other treatments<br><strong>Recall Reason</strong>: The 30 mg capsule was reported as superpotent (too much active ingredient); the 40 mg capsules included both superpotent and subpotent (less than the stated amount of active ingredient) products.<br><strong>Recall Initiation Date</strong>: January 12, 2026; classified as a Class II recall on April 8, 2026<br><br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98275">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">K.C. Pharma’s Artificial Tears Sterile Lubricant, Dry Eye Relief, Eye Drops Advanced Relief, Sterile Eye Drops AC, Sterile Eye Drops Original Formula, Sterile Eye Drops Redness Lubricant, Sterile Eye Drops Soothing Tears, and 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>: More than 3.1 million bottles containing 0.5 fluid ounces (15 mL) with expiration dates in 2026, distributed nationwide under these store-brand and private labels:<br>Best Choice, CVS Health, Discount Drug Mart, Equaline, Foster & Thrive, Geri Care, Good Neighbor Pharmacy, GoodSense, Grandall, Harris Teeter, HEB, Kroger, Leader (Cardinal Health), Lil’ Drug Store, Meijer, Publix, Quality Choice, Rite Aid, Rugby, TopCare, Walgreens.<br><strong>Drug Purpose</strong>: Eye drops for relieving dry eye, redness, and providing 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>: March 3, 2026<br><strong>Essential Extras</strong>: In August 2023, 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-654986-08032023">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.</p>
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<p><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/?Event=98533">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Levothyroxine Sodium Tablets (generic for Synthroid)</h3>
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<p><strong>Company</strong>: Macleods Pharma USA, Inc.<br><strong>Manufacturing Location</strong>: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Gujarat, India<br><strong>Scope</strong>: 1,315 bottles (1,000 count) of 150 mcg strength<br><strong>Drug Purpose</strong>: Treats hypothyroidism<br><strong>Recall Reason</strong>: Subpotent drug: the amount of active ingredient was less than the allowable range<br><strong>Recall Initiation Date</strong>: February 26, 2026<br><br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98510">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Prazosin Hydrochloride Capsules (generic for Minipress)</h3>
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<p><strong>Company</strong>: Appco Pharma<br><strong>Manufacturing Location</strong>: Appco Pharma, Piscataway, New Jersey for Biocon Pharma<br>Scope: 88,008 100-count bottles of 1 mg strength, 58,896 100-count bottles of 2 mg, and 28,157 100-count bottles of 5 mg strength capsules<br><strong>Drug Purpose</strong>: <a href="https://my.clevelandclinic.org/health/treatments/22321-alpha-blockers">Alpha blocker</a> treats high blood pressure and sometimes is used for PTSD-related nightmares<br><strong>Recall Reason</strong>: Presence of nitrosamine impurities above the FDA-recommended limit.<a href="https://www.fda.gov/drugs/drug-safety-and-availability/information-about-nitrosamine-impurities-medications">Nitrosamine impurities</a> may increase the risk of cancer.<br><strong>Recall Initiation Date</strong>: March 27, 2026<br><br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98658">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">traMADol Hydrochloride Tablets</h3>
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<p><strong>Company</strong>: Amneal Pharmaceuticals LLC<br><strong>Manufacturing Location</strong>: Ahmedabad, India<br><strong>Scope</strong>: 29,542 bottles (500-count), 50 mg strength<br><strong>Drug Purpose</strong>: Treats moderate to moderately severe pain. Tramadol is a <a href="https://medshadow.org/drug-updates-recalls/drug-safety/controlled-drug-classifications-schedule-i-ii-iii-iv-v/">DEA Schedule III</a> (moderate potential for addiction and misuse) synthetic opioid.<br><strong>Recall Reason</strong>: Presence of nitrosamine impurities above the FDA-recommended limit at 24 months during long-term stability testing. <a href="https://www.fda.gov/drugs/drug-safety-and-availability/information-about-nitrosamine-impurities-medications">Nitrosamine impurities</a> may increase the risk of cancer.<br><strong>Recall Initiation Date</strong>: March 19, 2026<br><br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/?Product=219255">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Xanax XR (alprazolam extended-release tablets)</h3>
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<p><strong>Company</strong>: Viatris, Inc.<br><strong>Manufacturing Location</strong>: Made in Ireland; distributed by Viatris Specialty LLC, Morgantown, West Virginia<br><strong>Scope</strong>: Unspecified quantity of 3 mg strength, 60-tablet bottles<br><strong>Drug Purpose</strong>: Treats panic disorder in adults, with or without <a href="https://medlineplus.gov/ency/article/000923.htm">agoraphobia</a> (fear and avoidance of certain places or situations)<br><strong>Recall Reason</strong>: Failed dissolution specifications: the tablets may not dissolve properly, potentially reducing their effectiveness.<br><strong>Recall Initiation Date</strong>: March 17, 2026<br><br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219233">FDA Enforcement Report</a></p>
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