FDA Recalls and Warnings: Black Spots Found on Seizure Med; Alcohol Dependence Drug May Not Dissolve Properly

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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 Acamprosate Calcium and Carbamazepine.</p>
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<p>All recalls in this installment are nationwide “Class II” recalls. 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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<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">Acamprosate Calcium Delayed-Release Tablets (generic for Campral)</h3>
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<p><strong>Company</strong>: Mylan Pharmaceuticals Inc. <br><strong>Manufacturing Location</strong>: Hyderabad, India, by Mylan Laboratories <br><strong>Scope</strong>: One lot (unspecified quantity) of 180-count bottles, 333 mg strength tablets<br><strong>Drug Purpose</strong>: Treatment of alcohol dependence in people who have stopped drinking. The medication helps reduce alcohol cravings and should be used as part of a comprehensive treatment program that includes counseling and psychosocial support.<br><strong>Recall Reason</strong>: Failed dissolution specifications; the tablets may not dissolve properly, potentially reducing their effectiveness.<br><strong>Recall Initiation Date</strong>: July 24, 2026<br><strong>Recall Level</strong>: Class II<br><strong>Essential Extras</strong>: Manufacturing location obtained from <a href="https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=75ddfd10-55b2-426e-bc74-3413cd0d7c94">product drug label</a>.<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99483">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Carbamazepine Tablets (generic for Tegretol)</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. and distributed by Taro Pharmaceuticals USA, Inc<br><strong>Scope</strong>: 1,968 bottles (1,000-count) 200 mg tablets<br><strong>Drug Purpose</strong>: Prevents and controls seizures; sometimes used for nerve pain<br><strong>Recall Reason</strong>: Black spots were found on tablets; the spots were caused by burnt excipient material (a substance other than the active ingredient) from the manufacturing process. <br><strong>Recall Initiation Date</strong>: August 3, 2026<br><strong>Recall Level</strong>: Class II<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221879">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Carbamazepine Tablets (generic for Tegretol)</h3>
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<p><strong>Company</strong>: Golden State Medical Supply <br><strong>Manufacturing Location</strong>: Haifa Bay, Israel, by Taro Pharmaceutical Industries Ltd.<br><strong>Scope</strong>: 1,200 bottles (100-count and 1,000-count) 200 mg tablets<br><strong>Drug Purpose</strong>: Prevents and controls seizures; sometimes used for nerve pain<br><strong>Recall Reason</strong>: Manufacturing quality problems; black spots were found on tablets.<br><strong>Essential Extras</strong>: Based on updated information from Sun Pharmaceutical’s carbamazepine recall, which involved drugs manufactured at the same facility, the spots were most likely caused by burnt excipient material (a substance other than the active ingredient) from the manufacturing process. Manufacturing location obtained from <a href="https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a1ce79d-18ea-f30b-e053-2995a90ad1fb">the product drug label</a>.<br><strong>Recall Initiation Date</strong>: August 7, 2026<br><strong>Recall Level</strong>: Class II <br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99614">FDA Enforcement Report</a></p>
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