FDA Drug Recalls and Warnings: Cancer-Linked Impurities in Blood Pressure Drug; Unsanitary U.S. Facilities Flagged

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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 Bisoprolol-Hydrochlorothiazide combination tablets, Oxycodone-Acetaminophen combination tablets, and Trazodone, along with three drug manufacturing facility warnings.</p>
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<p>The recalls for Oxycodone and Bisoprolol have been assigned a “Class II” level by the FDA (see below for definitions of types of recalls). The Trazodone recall has not yet been classified. These are nationwide supplier-level recalls and are not directed at consumers. However, consumers may wish to check the linked enforcement reports for 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">Bisoprolol Fumarate and Hydrochlorothiazide Tablets (generic for Ziac)</h3>
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<p><strong>Company</strong>: Unichem Pharmaceuticals USA Inc.<br><strong>Manufacturing Location</strong>: Unichem Laboratoris Ltd., Pilerne Industrial Estate, Bardez, Goa, India<br><strong>Scope</strong>: Quantity not specified; 100-count bottles of 2.5 mg/6.25 mg tablets<br><strong>Drug Purpose</strong>: Combination beta-blocker and diuretic used to treat high blood pressure<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> January 21, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98323">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Oxycodone and Acetaminophen Tablets (generic for Percocet)</h3>
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<p><strong>Company</strong>: SpecGx, LLC (Par Health)<br><strong>Manufacturing Location</strong>: Not specified; SpecGx location is Webster Groves, Missouri<br><strong>Scope</strong>: 287,988 bottles of 10 mg oxycodone 325 mg and acetaminophen (100-count); 74,544 bottles of 7.5 mg oxycodone 325 mg acetaminophen (100 count)<br><strong>Drug Purpose</strong>: Treats pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.<br><strong>Recall Reason:</strong> Failed tablet/capsule specifications, which means the tablet failed quality control tests. Imprint information that identifies a pill’s strength and type, which should always be printed on at least one side of a tablet, may be missing or only partially visible. These <a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f2137f1a-b49a-40bd-97ac-cd6b36e295f4">tablets</a> are white with an oval shape. They should be printed with “M523” on one side and “10/325” on the other side (for the 10mg strength tablet) or “M522” on one side and “7.5/325 (for the 7.5mg strength tablet).<br><strong>Recall Initiation Date</strong>: December 16, 2025<br><strong>Risk Information</strong>: Imprint information is <a href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-206">required by law</a> for most pills and tablets (“solid oral dosage forms”) and is vital for patient safety because it allows patients and their health care providers to identify medications that may not be in their original packaging.<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98136">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Trazodone Hydrochloride Tablets (formerly branded as Desyrel)</h3>
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<p><strong>Company</strong>: Granules Pharmaceuticals<br><strong>Manufacturing Location</strong>: Granules India Limited, Hyderabad, India<br><strong>Scope</strong>: 71,424 bottles of 50 mg tablets (100-count)<br><strong>Drug Purpose</strong>: Trazodone is an antidepressant; the mistakenly included medication Metoprolol Succinate treats high blood pressure.<br><strong>Recall Reason</strong>: Product mix-up: An unspecified number of bottles of 50 mg Trazodone from batch 6160008A contained 25 mg Metoprolol Succinate ER (extended release) tablets bearing the imprints I and 25.<br><strong>Recall Initiation Date:</strong> January 26, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=98345">FDA Enforcement Report</a></p>
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<h2 class="wp-block-heading">Facility Inspections – FDA Warning Letters</h2>
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<h3 class="wp-block-heading">Darmerica, LLC</h3>
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<p><strong>Type</strong>: Manufacturer of active pharmaceutical ingredients (APIs) and U.S. agent for imported APIs; repackages and distributes bulk API ingredients to compounding pharmacies and other drug manufacturers.<br><strong>FDA Department issuing Warning:</strong> Center for Drug Evaluation and Research (CDER)<br><strong>Warning Letter Date</strong>: December 8, 2025<br><strong>Facility Location</strong>: Davie, Florida<br><strong>Date(s) of Inspections</strong>: March 3, 2025, to March 19, 2025<br><strong>FDA Warning</strong>: Darmerica failed to properly oversee the sourcing, testing, repackaging, and labeling of APIs. Darmerica failed to comply with quality assurance requirements, including vetting of API suppliers and providing accurate documentation. The company accepts APIs from suppliers that have a history of noncompliance with Current Good Manufacturing Practice (CGMP). The company failed to perform adequate testing and approve the results for APIs before their release and distribution. The FDA found Darmerica’s response to its Form 483 inspection report to be inadequate.<br><strong>Types of Products Made</strong>: Active pharmaceutical ingredients (APIs) that are repackaged, relabeled, and distributed to compounding pharmacies and drug manufacturers. Specific ingredient names are redacted in the warning letter, but a <a href="https://ndclist.com/labeler/darmerica-llc">National Drug Code Database</a> indicates that 225 bulk powder ingredients are registered to Darmerica, LLC.<br><strong>Essential Extras:</strong> In required records identifying its suppliers, Darmerica provided an incorrect address for a company said to supply semaglutide, an ingredient used in popular compounded GLP-1 treatments for weight loss and type 2 diabetes. An FDA internet search turned up a different address tied to the supplier — an apartment in a residential building, not a manufacturing site. After placing the supplier on import alert, the agency visited the location and found it to be vacant. A listed contact said the company had gone out of business a year earlier and did not know where Darmerica had been obtaining its semaglutide. </p>
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<p>Other examples of egregious quality lapses at Darmerica are described in the FDA Warning letter.</p>
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<p><strong>Link</strong>: <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025">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">Revive Rx Pharmacy</h3>
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<p><strong>Type</strong>: A compounding pharmacy that sells directly to consumers and healthcare providers.<br><strong>FDA Department issuing Warning</strong>: Center for Drug Evaluation and Research (CDER)<br><strong>Warning Letter Date</strong>: September 22, 2025 (posted December 23, 2025)<br><strong>Facility Location</strong>: Houston, Texas<br><strong>Date(s) of Inspections</strong>: January 27, 2025, to February 7, 2025; Inspection report (Form FDA 483) sent February 7, 2025<br><strong>FDA Warning</strong>: Drug products were prepared under insanitary conditions and may have been contaminated. Violations included exposure of products to non‑sterile air, inadequate response to microbial contamination, insufficient airflow and media fill testing, poor sterilization controls, and weak environmental monitoring. Some of Revive Rx’s corrective actions in response to the inspection report lacked sufficient documentation and failed to ensure sterility assurance. <br><strong>Types of Products Made:</strong> Compounded sterile preparations, including weight loss, men’s and women’s health, hormone replacement, and mental health medications.<br><strong>Essential Extras</strong>: In April 2024, ReviveRX recalled 751 vials of compounded tirzepatide (a GLP-1 drug) because the vials contained testosterone instead of tirzepatide. This was a Class I recall, the most serious kind of recall.<br><br><strong>Link</strong>: <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/revive-rx-llc-dba-revive-rx-pharmacy-709509-09222025">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">Winder Laboratories, LLC</h3>
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<p><strong>Type</strong>: Drug manufacturer<br><strong>FDA Department issuing Warning</strong>: Center for Drug Evaluation and Research (CDER)<br><strong>Warning Letter Date:</strong> January 7, 2026<br><strong>Facility Location</strong>: Winder, Georgia<br><strong>Date(s) of Inspections</strong>: July 14, 2025, to August 5, 2025; Inspection Report (Form FDA 483) issued at the close of the inspection<br><strong>FDA Warning</strong>: Winder did not adequately clean or maintain the equipment used to make its prescription tablets. Visible drug residue, oxidized metal, and foreign material were seen on machines. Inspectors found that a metal detector used to catch metal fragments in products was not working. During the inspection, a metal screw was found inside a sealed bottle. The FDA found Winder’s response to the inspection report to be inadequate and noted that similar problems have been cited in past FDA inspections<br><strong>Types of Products Made</strong>: Prescription oral tablets; specific drug names are redacted in the warning letter, but a <a href="https://ndclist.com/labeler/winder-laboratories-llc">national drug code database</a> indicates that phenobarbital tablets, morphine sulfate oral solution, and dextroamphetamine are among the drugs made at this facility.<br><strong>Essential Extras</strong>: In May 2025, a Class II recall was issued for 5,676 bottles of 100 mg phenazopyridine tablets (used to relieve urinary tract infection pain) because of a product mix-up. A bottle contained phenobarbital tablets (a barbiturate used to control seizures or to relieve anxiety) instead of phenazopyridine.</p>
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<p><strong>Link</strong>: <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/winder-laboratories-llc-718601-01072026">FDA Warning Letter<br></a>Read the warning letter for a complete description of violations.</p>
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