1,319 recalls tagged with “fda regulated”.
ACME UNITED recalled Max Packaging Antibacterial Towelette nationwide in the United States after CGMP deviations were identified. Manufacturing quality deviations prompted the recall, classified as Class II and labeled as high hazard. Stop using the product immediately and contact ACME UNITED CORPORATION or your healthcare provider for guidance.
Med-Nap Cleansing Towelettes, manufactured by Acme United Corporation, were recalled nationwide on January 20, 2026. The recall cites CGMP deviations in manufacturing for benzalkonium chloride 0.13% towelettes. Consumers and healthcare providers should stop using the product immediately and contact Acme United for guidance.
Dynarex Obstetrical Towelettes Cleanser is under an active FDA recall as of Jan. 20, 2026. The recall cites CGMP Deviations that could affect product quality. Consumers and healthcare providers should stop using the product immediately and contact ACME United Corporation or a healthcare provider for guidance.
ACME United Corporation recalled First Aid Only BZK Antiseptic Towelettes nationwide after CGMP deviations were identified in manufacturing. The products carry NDC 0924-7116-03 and come in 50-wipe packages. Consumers should stop using the product and contact the company for guidance. A recall notice will be mailed to affected customers.
First Aid Only BZK Antiseptic Towelettes are recalled nationwide in 2026 after CGMP Deviations were identified at the Acme United Corporation facility. The recall cites CGMP Deviations that could affect product quality. Consumers should stop using the product and contact Acme United Corporation for guidance.
ACME United recalled Wipes Plus Hand Sanitizing Alcohol Free BZK Wipes sold nationwide on Jan. 20, 2026. The recall cites CGMP deviations in manufacturing. Consumers and healthcare providers should stop using the product immediately and contact ACME United or their healthcare provider for guidance.
Acme United recalled FIRST AID ONLY Hand Sanitizing Wipes, 1,000 wipes per case, nationwide in the United States, on 2026-01-20. The action follows CGMP Deviations cited by the maker. Stop using the wipes and contact Acme United for guidance.
ACME UNITED recalled antimicrobial hand wipes manufactured for Custom Packaging Co., Inc. and distributed nationwide in the United States. The recall cites CGMP deviations in manufacturing. Consumers and healthcare providers should stop using this product immediately and contact ACME UNITED for guidance.
Dynarex recalled 100-pack BZK Antiseptic Towelettes sold nationwide after FDA enforcement cited CGMP deviations. The recall covers multiple lots, including Lot 52347-R, 52348-R, 52349-R, 52350, 52351-R, 52352, Exp. Date Mar 2027 and Exp. Date Jun 2027. Consumers should stop using the product immediately and contact ACME UNITED CORPORATION or their healthcare provider for guidance.
Green Guard Antiseptic Wipes, distributed nationwide by ACME United Corporation, are being recalled as of January 20, 2026. FDA enforcement cites CGMP deviations in manufacturing for the benzalkonium chloride wipes, NDC 47682-056-73. Consumers and healthcare providers should stop using the product immediately and contact ACME United for guidance on refunds or replacements.
ACME UNITED recalled instant hand sanitizing wipes nationwide after FDA flagged CGMP deviations. The product, labeled for Children’s Healthcare of Atlanta and manufactured in the USA, contains benzalkonium chloride 0.13% and is sold 1,000 wipes per case under NDC 0924-7130-00. Consumers and healthcare providers should stop using this product immediately and contact ACME UNITED CORPORATION for next
Roche Diagnostics issued a nationwide recall of 1,261 Cobas Pro systems with cobas c 503 units in the United States. A software defect can cause erroneous, non-monotonic calibrations for spline-type assays. Labs should stop using the devices immediately and follow the manufacturer's recall instructions.
Siemens Healthcare Diagnostics recalled 4,885 Atellica CH Urine Albumin tests in 2026 after detecting falsely depressed results. The manufacturer notes that any urine albumin concentration above 40.0 mg/dL may report values from 6.2 to 40.0 mg/dL. Stop using the device immediately and follow the recall instructions.
Frederik's by Meijer Slow-Roasted Tomato & Parmesan Focaccia Bread recalled after metal fragments were found in 23,459 cases. The recalls spans Frederik's by Meijer, Fresh & Simple, HT Traders and Trader Joe's focaccia products. The metal fragments were traced to roasted tomatoes from an ingredient supplier. Stop using the product and contact the supplier for refunds or replacements.
Palmetto Gourmet Foods recalled 5,664,960 three-ounce packages of Vegetarian Chicken Flavor Ramen sold at multiple retailers nationwide after undeclared Yellow #5 was detected. The recall covers products with a Best By Date before 01/15/2027. Consumers should not eat this product and should contact Palmetto Gourmet Foods for refund or replacement information by mail.
Bader Enterprises recalls 60 pounds of Premium Food Jordan Almonds sold in New Jersey and New York. The product contains undeclared wheat and blue color additives. Consumers who purchased the product should not consume it. Contact Bader Enterprises for refund or replacement information via two or more notification methods.
GE Healthcare recalled 250 Centricity Universal Viewer Zero Footprint Client units distributed worldwide after finding a risk that patient information may not match displayed images in certain workflows. The issue affects ZFP v6.0 SP11.6, SP11.6.0.1 and SP11.6.1 when Patient Timeline is installed. Hospitals should stop using affected units and await instructions from GE Healthcare.
Specialty Process Labs recalled 58 grams of Thyroid, USP due to subpotency. The recall affects products distributed nationwide. Consumers should stop using the drug immediately and contact their healthcare provider.
Aesculap recalls 126 MINOP TROCAR 150MM devices distributed nationwide to U.S. hospitals and clinics after regulators flagged a shaft length issue. The shaft may be longer than specified, potentially harming tissue during procedures. Healthcare facilities should stop using the devices and follow manufacturer recall instructions immediately.
Medline Unna-Z Stretch Zinc Paste Bandage faces a high-risk labeling error. The recall covers 35,328 units distributed in the U.S. and other regions. Manufacturers warn to stop use immediately and follow recall instructions.