fda regulated Recalls

689 recalls tagged with “fda regulated”.

Health & Personal Care
HIGH
FDA DRUG

ACME UNITED Antimicrobial Hand Wipes Recall 2026 for CGMP Deviations

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.

ACME UNITED
CGMP Deviations
Read more
Health & Personal Care
MEDIUM
FDA DRUG

Green Guard Antiseptic Wipes Recall 2026 Over CGMP Deviations

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.

Green Guard Antiseptic Wipes
CGMP Deviations
Read more
Health & Personal Care
HIGH
FDA DEVICE

Roche Cobas Pro 1,261-Unit Recall Over Spline-Calibration Error (2026)

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.

Roche Diagnostics Operations
Software defect,
Read more
Health & Personal Care
HIGH
FDA DRUG

ACME UNITED Instant Hand Sanitizing Wipes Recalled for CGMP Deviations (2026)

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

ACME UNITED
CGMP Deviations
Read more
Health & Personal Care
HIGH
FDA DRUG

Acme United MED NAP BZK Antiseptic Towelettes Recalled in 2026 (100-Count)

Acme United Corporation recalled Med Nap BZK Antiseptic Towelettes, 100-count, distributed nationwide. The FDA-listed CGMP deviations raise concerns about manufacturing quality and product safety. Consumers and healthcare providers should stop using the product and follow the recall letter for guidance.

Acme United Corporation
CGMP Deviations
Read more
Health & Personal Care
HIGH
FDA DRUG

ACME UNITED Recalls Max Packaging Antibacterial Towelette for CGMP Deviations (2026)

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.

ACME UNITED
CGMP Deviations
Read more
Health & Personal Care
HIGH
FDA DRUG

ACME United Recalls Wipes Plus Hand Sanitizing Alcohol Free BZK Wipes (2026)

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
CGMP Deviations
Read more
Food & Beverages
HIGH
FDA FOOD

Frederik's by Meijer Focaccia Bread Recalled for Metal Fragments (2026)

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.

Bakkavor
Metal fragments
Read more
Health & Personal Care
HIGH
FDA DRUG

Specialty Process Labs Issues Recall for Subpotent Thyroid Drug

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.

Specialty Process Labs
Subpotent Drug
Read more
Health & Personal Care
HIGH
FDA DEVICE

GE Healthcare Centricity Universal Viewer ZFP Recall 250 Units Worldwide in 2026

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.

GE Healthcare
Under certain
Read more
Food & Beverages
HIGH
FDA FOOD

Bader Enterprises Recalls Premium Food Jordan Almonds in 2.0 oz & 3.5 oz Packaging (2026 Recall)

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.

Bader Enterprises
Contains undeclared
Read more
Health & Personal Care
HIGH
FDA DEVICE

Aesculap MINOP TROCAR 150MM Recall for 126 Units in 2026

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.

Aesculap
There is
Read more
Food & Beverages
HIGH
FDA FOOD

Live it Up Super Greens Recalled Due to Salmonella Contamination

Live it Up brand recalled 795,834 units of Super Greens powder on January 15, 2026, due to possible Salmonella Typhimurium contamination. The affected products are sold nationwide, including Puerto Rico and Guam. Consumers should not consume the product and seek refunds immediately.

SUPERFOODS
Products may
Read more
Food & Beverages
HIGH
FDA FOOD

Sevillo Fine Foods Recalls 520 Units of Slow Roasted Diced Tomatoes Over Metal Fragments (2026)

Sevillo Fine Foods recalled 520 units of Slow Roasted Diced Tomatoes distributed to California and North Carolina after the product may contain metal fragments. The product is frozen and packaged in bulk with a plastic liner inside a cardboard box. Consumers should not eat the product and should contact Sevillo Fine Foods for refund or replacement via email.

Sevillo Fine Foods
Product may
Read more
Health & Personal Care
HIGH
FDA DEVICE

Edermy Recalls PIE Trolley System Due to Lack of 510K Clearance

Edermy LLC recalled the PIE Trolley System Model 2005 on January 14, 2026 due to a lack of 510K clearance. The recall affects 27 units distributed nationwide across 15 states. Users must stop using the device and follow the manufacturer's instructions immediately.

Edermy
Lack of
Read more
Food & Beverages
HIGH
FDA FOOD

Rose and Shore Recalls 5,067.1 Cases of 14" Margarita Thin Crust Pizza for Metal Fragments (2026)

Rose and Shore recalled 5,067.1 cases of 14" Margarita Thin Crust Pizza sold at a single regional chain in California, Oregon, Arizona, Idaho and Texas. A potential foreign object has been found in tomatoes used in the product. Consumers should not eat this pizza and should contact Rose and Shore for refund or replacement by email.

Rose and Shore
potential foreign
Read more
Food & Beverages
HIGH
FDA FOOD

Diva Fam Recalls Sea Moss Gel Over Botulism Risk

Diva Fam Inc recalled 5,438,998 jars of Sea Moss Gel on January 9, 2026. The product may be contaminated with Clostridium botulinum, posing serious health risks. Consumers should not consume the product and seek refunds immediately.

Diva Fam
potential Clostridium
Read more