FDA Drug Recalls and Warnings: Foreign Substances in Children’s Ibuprofen, ED Drugs in Supplements, and 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 Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, Children's Ibuprofen Oral Suspension, MR. 7 SUPER 700000 Capsules, Pitavastatin Tablets, and Silintan Capsules. We are also highlighting a manufacturing facility inspection warning and a drug testing facility warning.<br><br>Two of the recalls in this installment have been assigned a “Class I” level by the FDA. This is the most serious type of recall (see below for definitions of each type). Class II and Class III 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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<h3 class="wp-block-heading">Recalls (Enforcement Reports Database)  </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-heading">Warning Letters (Warning Letters Database)</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-heading">Drug Imports Alerts Database</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">Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution</h3>
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<p><strong>Company</strong>: Apotex Corp.<br><strong>Manufacturing Location</strong>: Not specified; manufactured for Apotex Corp in Weston, Florida<br><strong>Scope</strong>: 107,136 vials (5mL) of 0.2%/0.5% strength<br><strong>Drug Purpose</strong>: Prescription eye drops treatment for open-angle glaucoma or ocular hypertension; lowers intraocular eye pressure<br><strong>Recall Reason</strong>: Lack of assurance of sterility: the product may not have been manufactured under proper sterile conditions<br><strong>Recall Initiation Date</strong>: March 5, 2026 (not yet classified)<br><strong>Essential Extras</strong>: Apotex has two additional ongoing recalls for this medication, also due to sterility concerns: over 150,000 bottles recalled beginning in September 2025 (<a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97561">Enforcement Report</a>) and 6,288 bottles recalled beginning in May 2025 (<a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=96954">Enforcement Report</a>)<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98536">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Children's Ibuprofen Oral Suspension </h3>
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<p><strong>Company</strong>: Strides Pharma Inc<br><strong>Manufacturing Location</strong>: Made in India for Taro Pharmaceuticals U.S.A., Inc.<br><strong>Scope</strong>: 89,592 bottles (4fl oz. or 120 mL) of 100 mg per 5 mL<br><strong>Drug Purpose</strong>: Over-the-counter liquid formulation pain reliever and fever reducer for children aged 2 to 11 years; nonsteroidal anti-inflammatory drug (NSAID)<br><strong>Recall Reason</strong>: Presence of foreign substance: consumer reports of a gel-like mass and black particles found in the product.<br><strong>Recall Initiation Date</strong>: March 2, 2026; assigned Class II recall on March 16, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98508">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">MR. 7 SUPER 700000 Capsules</h3>
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<p><strong>Company</strong>: StuffbyNainax LLC<br><strong>Manufacturing Location</strong>: Not specified; StuffbyNainax is in Huntsville, Texas<br><strong>Scope</strong>: 1-capsule blister cards; product was sold online in the United States between August 2025 and November 2025<br><strong>Drug Purpose</strong>: Marketed as a dietary supplement for “male enhancement”<br><strong>Recall Reason</strong>: FDA lab tests confirmed the presence of undeclared sildenafil and tadalafil, which are active ingredients in FDA-approved prescription drugs used to treat male erectile dysfunction. These ingredients should not be included in dietary supplements, as they pose serious risks like lowering blood pressure, increasing risk of heart attack or stroke in those with heart conditions, or risks when combined with nitrates.<br><strong>Recall Initiation Date:</strong> December 15, 2025; FDA assigned Class I recall (the most serious type) on March 18, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98256">FDA Enforcement Report</a> and <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/stuffbynainax-llc-issues-voluntary-nationwide-recall-mr7-super-700000-dietary-supplement-due">FDA Press Release for Consumers</a></p>
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<h3 class="wp-block-heading">Pitavastatin Tablets</h3>
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<p><strong>Company</strong>: Annora Pharma Private Limited<br><strong>Manufacturing Location</strong>: Annora Pharma Pvt. Ltd., Telengana, India, for Northstar Rx LLC<br><strong>Scope</strong>: 770 bottles (90-count) of 2 mg strength<br><strong>Drug Purpose</strong>: Treats high cholesterol<br><strong>Recall Reason</strong>: Product mix-up: one Pitavastatin tablet 1mg found in a bottle of Pitavastatin tablets 2mg<br><strong>Recall Initiation Date</strong>: February 3, 2026; FDA assigned Class III recall (the least serious type) on March 16, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98543">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Silintan Capsules</h3>
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<p><strong>Company</strong>: Anthony Trinh, 123Herbals LLC (marketed by Shanghai Chinese Medical Works, Shanghai, China)<br><strong>Manufacturing Location</strong>: Shanghai, China<br><strong>Scope</strong>: Unspecified quantity of 25-count bottles<br><strong>Drug Purpose</strong>: Marketed as a dietary supplement for the relief of joint and body aches<br><strong>Recall Reason</strong>: FDA lab tests confirmed the presence of undeclared meloxicam, a prescription NSAID drug used for pain and inflammation relief. Products containing meloxicam should not be included in dietary supplements. Patients face the risk of hypersensitivity reactions, gastrointestinal bleeding, ulceration, and kidney injury, particularly in older adults. Dangerous drug-drug interactions may occur in patients on blood thinners or other NSAIDs, increasing bleeding risk.<br><strong>Recall Initiation Date</strong>: October 20, 2025; FDA assigned Class I recall (the most serious type) on March 13, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98258">FDA Enforcement Report</a> and <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/anthony-trinh-123herbals-llc-123herbalscom-issues-nationwide-recall-silintan-capsules-due-presence">FDA Press Release for Consumers</a></p>
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<h2 class="wp-block-heading">FDA Warning Letters for Facility Inspections</h2>
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<h3 class="wp-block-heading">Simtra BioPharma Solutions (formerly Baxter BioPharma Solutions)</h3>
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<p><strong>Facility Inspected</strong>: Simtra Deutschland GmbH (formerly Baxter Oncology GmbH)<br><strong>Type</strong>: Contract drug manufacturer<br><strong>FDA Department issuing Warning</strong>: Center for Drug Evaluation and Research (CDER)<br><strong>Warning Letter Date</strong>: March 3, 2026<br><strong>Facility Location</strong>: Halle/Westphalia, Germany<br><strong>Date(s) of Inspections</strong>: September 18-26, 2025</p>
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<p><strong>FDA Warning</strong>: The company failed to prevent contamination and follow <a href="https://globalpharmacenter.com/manufacturing/a-beginners-guide-to-aseptic-pharmaceutical-manufacturing/">aseptic</a> (sterile) manufacturing guidelines necessary for drug production. It failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products. Long pipes used in the production process were found to be prone to contamination and not adequately sanitized.</p>
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<p>The FDA found that Simtra manufactured dozens of batches of drugs using potentially compromised equipment. Investigators observed particles, such as loose, visible fibers, dislodging from covers in critical drug-filling areas. Fibers were also observed on tubing in two locations. The company’s response to the FDA Inspection Form 483 was found to be inadequate. The company has 15 days to respond to the warning letter and must schedule a teleconference meeting with the FDA.</p>
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<p><strong>Types of Products Made</strong>: Sterile drugs that require production in an aseptic environment. The <a href="https://simtra.com/our-facilities/halle-westfalen-germany/">company website</a> says the Halle facility makes cytotoxic (such as cancer) drugs in liquid and lyophilized (freeze-dried) vials.</p>
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<p><strong>Essential Extras</strong>:  In its “<a href="https://www.fda.gov/media/71026/download">Guidance for Industry: Sterile Drug Products Produced By Aseptic Processing — Current Good Manufacturing Practice</a>,” the FDA explains that drugs can be sterilized in two ways. In most cases, the product is sterilized in its final container using methods such as heat or irradiation, a process known as “terminal sterilization.”</p>
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<p>When sterile drugs are produced by “aseptic processing,” the drug ingredients, container, and closure are sterilized separately before the product is brought together. For this process, containers must be filled and sealed in an extremely high-quality environment. Drugs commonly manufactured with aseptic processing include eye drops, injectables, vaccines, I.V. medications, and antibiotics.</p>
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<p>In its warning letter to Simtra, the FDA included a reminder about CGMP for aseptic processing with a link to the FDA industry guidance document.</p>
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<p><strong>Link</strong>: <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/simtra-biopharma-solutions-720436-03032026">FDA Warning Letter<br></a>Read the warning letter for a complete description of violations.</p>
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<h3 class="wp-block-heading">Tentamus India Private Limited</h3>
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<p><strong>Type</strong>: Contract testing laboratory for pharmaceuticals<br><strong>FDA Department issuing Warning</strong>: Center for Drug Evaluation and Research (CDER)<br><strong>Warning Letter Date</strong>: March 3, 2026<br><strong>Facility Location</strong>: Hyderabad, Telangana, India<br><strong>Date(s) of Inspections</strong>: August 14-22, 2025</p>
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<p><strong>FDA Warning</strong>: The company failed to ensure that all CGMP (Current Good Manufacturing Practice) records were retained and available for review. The FDA investigator discovered two garbage bags containing torn analytical records, including chromatographic results, unidentified number lists, and impurity method validation spreadsheets with handwritten notes. Official records for a validation study were handwritten, while the original data was in the garbage bags.</p>
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<p>Reliability of data was found to be compromised because of failures to maintain complete records of the conditions and data associated with all tests. Also, the company did not investigate out-of-specification (OOS) test results and did not always notify its customers about problematic results. Failure to comply with CGMP may affect the quality, safety, and efficacy of the drugs tested. Tentamus’ response to the FDA Inspection Form 483 was found to be inadequate. The company is instructed to respond to the warning letter within 15 working days.</p>
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<p><strong>Types of Products Made</strong>: Provides contract testing services for finished pharmaceuticals to verify drug quality, safety, stability, sterility, strength, and purity. It generates data for FDA submissions, such as drug applications and ongoing quality control.</p>
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<p><strong>Link</strong>: <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tentamus-india-private-limited-720463-03032026">FDA Warning Letter<br></a>Read the warning letter for a complete description of violations.</p>
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