Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
Datascope Corp. is updating battery runtime and cycle specifications in the technical documentation for the CS100 IABP cardiac support device distributed worldwide.
HTO Nevada Inc. dba Kirkman is recalling MAXIMUM ZONE 2 4% Lidocaine Cream because stability data does not support the labeled expiration date. The affected product was distributed nationwide.
ACME United Corporation is recalling First Aid Only BZK Antiseptic Towelettes nationwide due to deviations from Good Manufacturing Practice. Consumers should stop using affected lots.
Bader Enterprises is recalling Premium Food Jordan Almonds due to undeclared wheat and synthetic food colors (FD&C Blue 1 Lake and FD&C Blue 2 Lake) that may pose a risk to consumers with wheat allergies.
ACME UNITED CORPORATION is voluntarily recalling BZK Antiseptic Towelettes nationwide due to manufacturing quality deviations. Multiple lot numbers with various expiration dates were distributed throughout the United States.
Med Nap Benzalkonium Chloride Antiseptic towelettes are being recalled nationwide due to manufacturing practice deviations. This voluntary recall was initiated by Acme United Corporation with no reported adverse events.
Cipla USA recalls Nilotinib 200 mg capsules (Lot 5GJ0223) nationwide due to failed appearance and description specifications in stability testing.
Cipla USA, Inc. is recalling Nilotinib 150 mg capsules nationwide due to failed tablet/capsule specifications discovered during 6-month stability testing. The product's visual appearance and description did not meet established quality standards.
Prime Food Processing is recalling dried croaker fish that were not properly eviscerated. The recall covers 79 cases distributed to 18 U.S. states and poses a contamination risk.
MIN JIANG FOOD STORE INC is recalling frozen fish balls (UPC #810093891325) due to undeclared wheat and sesame allergens. The product was distributed across eight states to restaurants and retail stores.
MIN JIANG FOOD STORE INC is recalling frozen fish balls with undeclared wheat and sesame allergens. Consumers with allergies to these ingredients should not consume the product.
Navitas Organics Organic Chia Seeds are recalled due to potential Salmonella contamination. Affected units were distributed across 26 U.S. states; consumers should discard the product or return it to the retailer.
Frozen fish balls from Min Jiang Food Store Inc are being recalled because they contain undeclared wheat and sesame allergens. The recall affects 344 cases distributed across eight states.
Oregon Potato Company LLC is recalling IQF blueberries in cases and totes due to potential Listeria monocytogenes contamination. Affected product was distributed to business customers in MI, OR, WA, WI, and Canada.
Medline Industries recalls dialysis on/off kits with defective silicone seals that may prevent fluid injection/withdrawal and cause therapy delays. Affected units may leak, interrupt therapy, or expose patients to contaminants and air.
Agebox is recalling iKids-Growth Night Formula for containing an undeclared pharmaceutical ingredient (ibutamoren), a growth hormone stimulant. Consumers should stop use immediately.
SB FOOD LLC is recalling Yoyo Gummy Grape Plus Flavor gummies because they contain Carmoisine (E122), an unapproved food color additive in the United States. The product was distributed to 15 states.
J2C Hawaii LLC recalls Tiki Bar Candy (Dark Chocolatey Peanut Butter & Pretzel) sold in Hawaii because the product label fails to declare peanuts in the required allergen statement despite containing peanut ingredients.
Valley Springs bottled water products, including infant and pet water varieties, have been recalled due to being bottled under insanitary conditions. The recall affects approximately 379,868 units distributed in Illinois and Wisconsin.
Olympus Corporation is recalling the Olympus Resection Sheath Model A2666T due to complaints of the ceramic tip breaking. The device is used for urological procedures and distributed nationwide.
Olympus is recalling the Inner Sheath Model A2642 urological endoscope due to complaints that the ceramic tip breaks. The device has been distributed nationwide.
Medline has recalled certain Nail Kits because the sterile saline wound wash component may not meet required sterility standards. The affected kits were distributed nationwide and internationally.
Olympus is recalling 1,676 units of the Resection Sheath Model A22042A nationwide due to reports that the ceramic tip can break. The device is used in urologic procedures.
Medline Industries is recalling approximately 31,848 dialysis dressing change kits with defective Tego Connectors. Silicone seals may crack or dome, potentially blocking fluid flow, causing therapy delays, or allowing biological contamination.
Edermy LLC is recalling PIE PAK medical device models due to lack of FDA 510(k) clearance. Approximately 11,200 units were distributed nationwide without required regulatory approval.