FDA Recalls and Warnings: Tums, 14 Store-Brand Antacids Flagged for Metal Contamination

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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 of Tums and 14 private-label antacid chewable products. The FDA has designated these as Class II recalls (see below for an explanation of recall classifications).</p>
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<p>Although these are supplier-level recalls and were not issued directly to consumers, some retailers, including <a href="https://www.cvs.com/content/dam/enterprise/cvsretail/help-assets/recall_pdf/Haleon_TumsAssrtFruit_814467.pdf">CVS</a> and the <a href="https://corp.commissaries.com/our-agency/newsroom/news-releases/perrigo-direct-recalls-goodsenser-antacids-due-possible-metal">Defense Commissary Agency</a>, have announced recalls for affected products sold in their stores. Consumers may want to review the linked FDA enforcement report to check whether their product's lot number or expiration date is affected.</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.<br></p>
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<h2 class="wp-block-heading">Antacid Recalls</h2>
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<h3 class="wp-block-heading">Extra Strength Antacid Tablets (Calcium Carbonate), various brands and strengths</h3>
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<p><strong>Company</strong>: Guardian Drug Co. Inc. (Dayton, New Jersey)<br><strong>Manufacturing Location</strong>: Dayton, New Jersey<br><strong>Scope</strong>: Unspecified quantity of Tums brand (by Haleon) and private-label brands of over-the-counter calcium carbonate antacid medications:</p>
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<li><strong>24/7 life BY 7-ELEVEN, Extra strength Antacid Tablets,</strong> Calcium Carbonate 750 mg, 96 chewable tablets(Distributed by 7-ELEVEN)<br></li>
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<li><strong>CAREone, EXTRA STRENGTH CALCIUM ANTACID</strong>, Calcium Carbonate 750 mg, 96 chewable Tablets<br></li>
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<li><strong>CAREone, ULTRA STRENGTH CALCIUM ANTACID</strong>, Calcium Carbonate 1000 mg, 72 chewable Tablets (Distributed by FOODHOLD U.S.A, LLC)<br></li>
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<li><strong>DISCOUNT Drug Mart, EXTRA STRENGTH</strong>, ANTACID TABLETS, Calcium Carbonate 750 mg, 96 Tablets (Distributed by Drug Mart- Food Fair)<br></li>
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<li><strong>EQUALINE extra strength</strong>, antacid tablets, calcium carbonate 750mg, 96 chewable tablets<br></li>
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<li><strong>EQUALINE ultra strength</strong>, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets<br>(Distributed by SUPERVALU INC.)<br></li>
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<li><strong>Extra strength Antacid Calcium Carbonate 750 mg</strong>, chewable tablets, 96-count bottle<br>(Distributed by Casey's Marketing Company)<br></li>
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<li><strong>FAMILY WELLNESS, ULTRA STRENGTH</strong>, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS<br></li>
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<li><strong>FAMILY WELLNESS, ULTRA STRENGTH</strong>, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS (Distributed by Midwood Brands, LLC)<br></li>
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<li><strong>Good Neighbor Pharmacy, extra strength</strong> <strong>Antacid Calcium Carbonate 1000 mg</strong>, 72 chewable tablets<br></li>
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<li><strong>Good Neighbor Pharmacy, extra strength</strong> <strong>Antacid Calcium Carbonate 750 mg</strong>, chewable, 96-count bottle (Distributed by AmerisourceBergen)<br></li>
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<li><strong>GOODSENSE Extra Strength,</strong> <strong>Antacid TABLETS, Calcium Carbonate 750 mg</strong>, 96 Chewable Tablets<br></li>
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<li><strong>GOODSENSE Ultra Strength</strong>, <strong>Antacid TABLETS, Calcium Carbonate 1000 mg</strong>, 72 Chewable Tablets (Distributed by Geiss, Destin & Dunn)<br></li>
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<li><strong>H.E.B Extra Strength Calcium Carbonate Antacid Tablets</strong>, Calcium Carbonate 750 mg, 96 Chewable Tablets (Made With Pride & Care For H.E.B)<br></li>
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<li><strong>HALEON CALCIUM CARBONATE TUMS ANTACID</strong>, <strong>Assorted Fruit Tablets, 1000 mg,</strong> 160-count bottle<br></li>
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<li><strong>HALEON CALCIUM CARBONATE TUMS ANTACID</strong>, <strong>Assorted Fruit Tablets, 750 mg</strong>, 330-count bottle (Haleon, Warren, NJ)<br></li>
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<li><strong>Harris Teeter, ULTRA STRENGTH ANTACID</strong>, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS (Distributed by Harris Teeter, LLC)<br></li>
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<li><strong>HyVee, Extra Strength Antacid</strong>, <strong>Calcium Carbonate 750 mg,</strong> 96 CHEWABLE TABLETS<br></li>
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<li><strong>HyVee, Ultra Strength Antacid</strong>, <strong>Calcium Carbonate 1000 mg</strong>, 72 CHEWABLE TABLETS<br>(Distributed By Hy-Vee Inc.)<br></li>
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<li><strong>KIRKLAND Signature, ULTRA STRENGTH ANTACID</strong>, Calcium Carbonate, 1000 mg, 265-count bottle  (Manufactured By  Guardian Drug Company, Inc., Dayton Nj For Costco Wholesale Corporation)<br></li>
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<li><strong>MARKET BASKET ANTACID Calcium Carbonate 1000 mg</strong>, ULTRA STRENGTH, 72 Tablets<br>(Distributed by  De Moules Supermarkets, Inc.)<br></li>
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<li><strong>TopCare health, EXTRA STRENGTH,</strong> Antacid Tablets, CALCIUM CARBONATE 750mg, 96 CHEWABLE TABLETS<br></li>
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<li><strong>TopCare health, ULTRA STRENGTH,</strong> Antacid Tablets, CALCIUM CARBONATE 1000mg, 72 CHEWABLE TABLETS<br>(Distributed by Topco Associates LLC)</li>
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<p><strong>Drug Purpose:</strong> Used for heartburn, acid indigestion, and sour stomach<br><strong>Recall Reason</strong>: Possible presence of small metallic particles in the chewable tablets<br><strong>Recall Initiation</strong> Date: May 28, 2026<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99098">FDA Enforcement Report</a><br><strong>Essential Extras</strong>: According to a Defense Commissary Agency <a href="https://corp.commissaries.com/our-agency/newsroom/news-releases/perrigo-direct-recalls-goodsenser-antacids-due-possible-metal">press release</a> about the Goodsense brand, which is sold at military commissary stores, the possible metal contamination is attributed to the inactive ingredient Adipic acid.</p>
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<p>According to a Bancroft Construction <a href="https://www.bancroftconstruction.com/project/guardian-drug-manufacturing-facility/">press release</a>, in 2024 Bancroft completed construction on a 275,000 square-foot expansion to Guardian Drug’s manufacturing warehouse facility in Dayton, NJ.</p>
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