FDA Recalls and Warnings: Sterility Concerns For Millions of Dry Eye Drops, Plus Levothyroxine and Generic Zyrtec Recalls

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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 Amlodipine and Olmesartan Medoxomil, Carbamide Peroxide, Cetirizine, Cyproheptadine Hydrochloride Syrup, Dabigatran Etexilate, Divalproex, Fexofenadine, Levothyroxine, Nystatin Cream, Rohto Brand Eye Drops, and Trokendi XR.</p>
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<p>All recalls in this installment are nationwide “Class II” recalls, except for Fexofenadine, which is a Class III recall, and Cetirizine, Dabigatran, Divalproex, and Trokendi XR, which have not yet been classified. 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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<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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<h3 class="wp-block-accordion-heading"><button type="button" class="wp-block-accordion-heading__toggle"><span class="wp-block-accordion-heading__toggle-title">Warning Letters (Warning Letters Database)</span><span class="wp-block-accordion-heading__toggle-icon" aria-hidden="true">+</span></button></h3>
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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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<h3 class="wp-block-accordion-heading"><button type="button" class="wp-block-accordion-heading__toggle"><span class="wp-block-accordion-heading__toggle-title">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.<br></p>
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<h2 class="wp-block-heading">Drug Recalls</h2>
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<h3 class="wp-block-heading">Amlodipine and Olmesartan Medoxomil Tablets (generic for Azor)</h3>
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<p><strong>Company</strong>: Ascend Laboratories, LLC<br><strong>Manufacturing Location</strong>: India by Alkem Laboratories Ltd.<br><strong>Scope</strong>: 6,192 bottles (30-count), 10 mg/20 mg strength<br><strong>Drug Purpose</strong>: A combination medication used to treat high blood pressure. <br><strong>Recall Reason</strong>: Failed dissolution specification; the tablets may not dissolve properly, potentially reducing their effectiveness; the amount of active ingredient Olmesartan medoxomil was less than the required amount.<br><strong>Essential Extras</strong>: In May 2026, <a href="https://medshadow.org/drug-updates-recalls/fda-recalls-and-warnings/gas-x-contaminated-generic-cymbalta-cancer-risks-moringa-salmonella-outbreak/">Ascend had a similar recall</a> for this drug (5 mg/40 mg strength).<br><strong>Recall Initiation Date</strong>: July 8, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99385">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Carbamide Peroxide Ear Drops (multiple brands)</h3>
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<p><strong>Company</strong>: Bell Pharmaceuticals, Inc<br><strong>Manufacturing Location</strong>: Not provided; distributed nationwide by multiple distributors (see below)<br><strong>Scope</strong>: 11 private labels of 6.5% strength, 0.5 FL Oz (15 mL) bottles and kits (with washer bulbs):</p>
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<li>Audiologist's Choice, kits and bottles; 5,762 units (distributed by Oaktree Products Inc.)</li>
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<li>CAREone bottles; 1,201 units (distributed by Foodhold U.S.A, LLC)</li>
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<li>Clinere bottles, 29, 474 units (distributed by Quest Products LLC)</li>
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<li>CVS Health, bottles and kits; 106,301 units (distributed by CVS Pharmacy Inc.)</li>
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<li>Family Wellness, kits; 11, 977 units (distributed by Midwood Brands LLC)</li>
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<li>Foster & Thrive bottles, 31,094 units (distributed by McKesson Corp.)</li>
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<li>Good Neighbor Pharmacy, kits and bottles; 20, 160 units (distributed by AmerisourceBergen)</li>
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<li>Leader, bottles and kits; 5, 471 units (distributed by Cardinal Health)</li>
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<li>Meijer, Washer Bulb Included; 993 units (distributed by Meijer Distribution, Inc.)</li>
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<li>Qc Quality Choice, Washer Bulb Included; 15, 843 units (distributed by C.D.M.A.)</li>
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<li>Topcare Health, Washer Bulb & Drops Included; 16,156 units (distributed by Topco Associates LLC)</li>
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<p><strong>Drug Purpose</strong>: Over-the-counter earwax removal aid for adults and children 12 and older; softens, loosens, and helps remove excessive earwax.<br><strong>Recall Reason</strong>: Subpotent drug; low pH and a significantly reduced amount of active ingredient carbamide peroxide, measuring about 0.6% versus the labeled amount of 6 to 7%.<br><strong>Recall Initiation Date</strong>: June 25, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99278">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Cetirizine Hydrochloride Tablets (generic for Zyrtec)</h3>
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<p><strong>Company</strong>: J. B. Chemicals & Pharmaceuticals Ltd.<br><strong>Manufacturing Location:</strong> Mumbai, India, by Unique Pharmaceutical Laboratories, a Division of J.B. Chemicals & Pharmaceuticals Ltd.<br><strong>Scope</strong>: 34,020 bottles (100-count), four lots; 5 mg strength<br><strong>Drug Purpose</strong>: Antihistamine used for allergy treatment<br><strong>Recall Reason</strong>: Some 5 mg cetirizine hydrochloride tablets may have been contaminated with ranitidine, a heartburn medication. Customers reported discolored tablets and red spots. People who are allergic to ranitidine could experience a serious allergic reaction if they take the contaminated tablets.<br><strong>Recall Initiation Date</strong>: June 24, 2026; recall not yet classified, but likely to be assigned as “Class I” due to the severity of the health risk.<br><strong>Link</strong>: <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/unique-pharmaceutical-laboratories-div-j-b-chemicals-pharmaceuticals-ltd-issues-voluntary-nationwide">FDA Press Release</a> and <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99321">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Cyproheptadine Hydrochloride Syrup (generic for Periactin, which has been discontinued)</h3>
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<p><strong>Company</strong>: Rising Pharma Holdings, Inc.<br><strong>Manufacturing Location</strong>: Brockton, Massachusetts, by Lyne Laboratories<br><strong>Scope</strong>: 74,208 units 473 mL (1 pint); 2 mg/5 mL<br><strong>Drug Purpose</strong>: Prescription antihistamine used to treat allergy symptoms and, in some cases, used off-label to stimulate appetite<br><strong>Recall Reason</strong>: Particles were found floating in the medication after it began to crystallize inside the bottle.<br><strong>Recall Initiation Date</strong>: July 13, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99401">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Dabigatran Etexilate Capsules (generic for Pradaxa)</h3>
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<p><strong>Company</strong>: Ascend Laboratories, LLC<br><strong>Manufacturing Location</strong>: Mumbai, India, by Alkem Laboratories<br><strong>Scope</strong>: 1,753 cartons (60-count per carton), 110 mg strength; 2,717 cartons (20-count per carton), 150 mg strength<br><strong>Drug Purpose</strong>: Blood thinner used to reduce the risk of stroke and blood clots<br><strong>Recall Reason</strong>: Stability testing found that the medication exceeded acceptable limits for impurities after 12 months, which could affect its quality and effectiveness.<br><strong>Recall Initiation Date</strong>: June 30, 2026; recall not yet classified<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99330">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Divalproex Sodium Delayed-Release Tablets (generic for Depakote)</h3>
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<p><strong>Company</strong>: Bionpharma Inc.<br><strong>Manufacturing Location</strong>: India<br><strong>Scope</strong>: unspecified quantity of 500-tablet bottles 500 mg strength<br><strong>Drug Purpose</strong>: An anticonvulsant and mood-stabilizing medication used to treat seizures, bipolar disorder, and migraine prevention<br><strong>Recall Reason</strong>: Presence of foreign tablets/capsules (foreign tablets not identified)<br><strong>Recall Initiation Date</strong>: June 26, 2026; recall not yet classified<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99316">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Fexofenadine Hydrochloride Tablets (generic for Allegra)</h3>
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<p><strong>Company</strong>: Ohm Laboratories, Inc.<br><strong>Manufacturing Location</strong>: Not specified<br><strong>Scope</strong>: 9,048 bottles (150-count) 180 mg strength<br><strong>Drug Purpose</strong>: Antihistamine used to relieve allergy symptoms<br><strong>Recall Reason</strong>: Failed impurities and degradation specifications; this could affect product shelf life and quality.<br><strong>Recall Initiation Date</strong>: June 1, 2026; Class III Recall<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99110">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Levothyroxine Sodium Tablets</h3>
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<p><strong>Company</strong>: Major Pharmaceuticals<br><strong>Manufacturing Location</strong>: Not specified; distributed by Cardinal Health, Indianapolis, Indiana<br><strong>Scope</strong>: Unspecified quantity of 25 mcg, 50 mcg, 75 mcg, 88 mcg, 112 mcg, 125 mcg, 150 mcg, 100-tablet 10X10 blister packs; unspecified quantity of 25 mcg, 50 mcg, 75 mcg, 125, 150 mcg 10-tablet 10X1 blister packs<br><strong>Drug Purpose</strong>: Thyroid hormone replacement to treat hypothyroidism<br><strong>Recall Reason</strong>: Subpotent; the amount of active ingredient was less than the allowable range.<br><strong>Recall Initiation Date</strong>: July 13, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99399">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Nystatin Topical Cream</h3>
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<p><strong>Company</strong>: Padagis US LLC<br><strong>Manufacturing Location</strong>: Yeruham, Israel by Padagis<br><strong>Scope</strong>: 180,936 (15 g) tubes of 100,000 Nystatin Units per gram<br><strong>Drug Purpose</strong>: Prescription antifungal cream used to treat yeast and other fungal skin infections.<br><strong>Recall Reason</strong>: Subpotent drug; the amount of active ingredient was found to be less than the allowable range during long-term stability testing.<br><strong>Recall Initiation Date</strong>: June 23, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99283">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Rohto Brand Eye Drops</h3>
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<p><strong>Company</strong>: Rohto-Mentholatum (Vietnam) Co., Ltd.<br><strong>Manufacturing Location</strong>: Vietnam by Rohto-Mentholatum (Vietnam)<br><strong>Scope</strong>: More than 12 million cartons of these eight over-the-counter Rohto eye drop products were distributed at retailers nationwide by the Mentholatum Company. All are .4 ounce or .34 ounce size bottles:</p>
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<li>Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%); 1,033,266 cartons</li>
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<li>Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%); 6,076,306 cartons</li>
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<li>Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ; 499,673 cartons</li>
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<li>Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%); 1,278,457 cartons</li>
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<li>Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%); 65219 cartons</li>
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<li>Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%); 97201 cartons</li>
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<li>Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ; 353 cartons</li>
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<li>Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%); 2,910,148 cartons</li>
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<p><strong>Drug Purpose</strong>: Over-the-counter eye redness relief and lubricant eye drops<br><strong>Recall Reason</strong>: Lack of assurance of sterility<br><strong>Recall Initiation Date</strong>: July 14, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99440">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Trokendi XR (topiramate) Extended-Release Capsules</h3>
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<p><strong>Company</strong>: Supernus Pharmaceuticals, Inc.<br><strong>Manufacturing Location</strong>: Winchester, Kentucky, by Catalent Pharma Solutions<br><strong>Scope</strong>: Unspecified quantity of 30-capsule bottles, 25 mg strength<br><strong>Drug Purpose</strong>: Treats epileptic seizures; Used to help prevent migraines<br><strong>Recall Reason</strong>: Failed dissolution specifications; the capsule may not release the drug properly<br><strong>Recall Initiation Date:</strong> July 6, 2026; this recall is not yet classified<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99375">FDA Enforcement Report</a></p>
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