FDA Recalls and Warnings: Blood Pressure Drug Recalled for Second Time in 3 Months; Some GLP-1 Pens May Contain No Medication

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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 covering recalls for chlorthalidone, exanatide, fluphenazine hydrochloride, nystatin, olanzapine, and ranolazine. </p>
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<p>Of particular note: certain chlorthalidone 25 mg tablets manufactured by Inventia Healthcare have been recalled for the second time in three months, with both recalls involving problems with how the tablets dissolve.</p>
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<p>Consumers may wish to check the linked press release 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 has-icon has-icon-right"><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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<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">Chlorthalidone Tablets</h3>
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<p><strong>Company</strong>: Inventia Healthcare Limited<br><strong>Manufacturing Location</strong>: Ambernath (East), India by Inventia Healthcare Limited<br><strong>Scope</strong>: 13,567 bottles (100-count) of 25 mg tablets distributed nationwide in the United States<br><strong>Drug Purpose</strong>: A diuretic (“water pill”) used to treat high blood pressure. Chlorthalidone is also used to reduce fluid retention in the body (edema) caused by conditions such as heart failure, liver disease, and kidney disease.<br><strong>Recall Reason</strong>: Failed dissolution specifications: the capsules may not dissolve properly, potentially reducing their effectiveness.<br><strong>Recall Initiation Date</strong>: September 3, 2026<br><strong>Recall Level</strong>: Class II<br><strong>Essential Extras</strong>: Inventia issued a similar <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99136">recall</a> for 25 mg chlorthalidone tablets in June 2026.<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99806">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Exenatide Injection (generic for Byetta, which has been discontinued)</h3>
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<p><strong>Company</strong>: Amneal Pharmaceuticals of New York, LLC<br><strong>Manufacturing Location</strong>: Ahmedabad, India, by Amneal Pharmaceuticals Pvt. Ltd.<br><strong>Scope</strong>: 5,694 prefilled pens for subcutaneous use, 250 mcg/mL, 1.2 mL, 5 mcg per dose<br><strong>Drug Purpose</strong>: GLP-1 receptor agonist for adults with type 2 diabetes, to be used along side diet and exercise for blood-glucose control. This medication is injected twice daily.<br><strong>Recall Reason</strong>: Defective delivery system. Some prefilled pens may contain no medication.<br><strong>Recall Initiation Date</strong>: August 28, 2026<br><strong>Recall Level</strong>: Class II<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99762">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Fluphenazine Hydrochloride Tablets (generic for Prolixin, which has been discontinued)</h3>
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<p><strong>Company</strong>: Ajanta Pharma USA Inc.<br><strong>Manufacturing Location</strong>: India<br><strong>Scope</strong>: 403,200 tablets (1 mg strength) in 100-count bottles distributed nationwide in the United States <br><strong>Drug Purpose</strong>: Antipsychotic for managing schizophrenia and psychotic disorders<br><strong>Recall Reason</strong>: Failed impurities and degradation specifications. In the 18-month long-term stability test, the product tested 0.1% above the allowed limit for an unidentified organic impurity. This could affect shelf life and product quality.<br><strong>Recall Initiation Date</strong>: August 25, 2026<br><strong>Recall Leve</strong>l: Class III<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99733">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Nystatin Cream</h3>
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<p><strong>Company</strong>: Sun Pharmaceutical Industries Inc.<br><strong>Manufacturing Location</strong>: Haifa Bay, Israel, by Taro Pharmaceutical Industries Ltd.<br>and distributed by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, New York<br>Scope: Unspecified quantity of 15 g tubes distributed nationwide in the United States<br><strong>Drug Purpose</strong>: Prescription antifungal cream used to treat yeast and other fungal skin infections.<br><strong>Recall Reason</strong>: Failed stability specifications, which may affect shelf life and product effectiveness.<br><strong>Recall Initiation Date</strong>: September 14, 2026<br><strong>Recall Level</strong>: II<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99876">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Olanzapine Tablets (generic for Zyprexa)</h3>
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<p><strong>Company</strong>: Macleods Pharmaceuticals Limited<br><strong>Manufacturing Location</strong>: Theda Village in Baddi tehsil of Solan district, Himachal Pradesh, India, by Macleods Pharmaceuticals, Ltd.<br><strong>Scope</strong>: 22,032 30-count bottles of 5 mg tablets<br><strong>Drug Purpose</strong>: Atypical antipsychotic that treats schizophrenia and bipolar I disorder.<br><strong>Recall Reason</strong>: Failed impurities/degradation specifications. The product contained organic and unspecified impurities above allowed limits.<br><strong>Recall Initiation Date</strong>: August 27, 2026<br><strong>Recall Level</strong>: Class III<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99773">FDA Enforcement Report</a> </p>
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<h3 class="wp-block-heading">Ranolazine Extended-Release Tablets</h3>
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<p><strong>Company</strong>: Ajanta Pharma USA Inc.<br><strong>Manufacturing Location</strong>: India by Ajanta Pharma Limited<br><strong>Scope</strong>: Unspecified quantity of 60-count bottles of 1,000 mg strength extended-release tablets<br><strong>Drug Purpose</strong>: Treats chronic angina, a recurring chest discomfort or chest pain caused by reduced blood flow to the heart.<br><strong>Recall Reason</strong>: Failed dissolution specifications; the capsules may not dissolve properly, potentially reducing their effectiveness.<br><strong>Recall Initiation Date</strong>: September 17, 2026<br><strong>Recall Leve</strong>l: Not yet classified<br><strong>Essential Extras</strong>: Manufacturing location was obtained from <a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8bfd1a61-547a-4847-ae4e-480b17da6272">product drug label</a>.<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99893">FDA Enforcement Report</a></p>
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