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.
The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.
FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.
Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.
Somerset Therapeutics is recalling 71,310 vials of Cisatracurium Besylate Injection, 20 mg/10 mL, after out of specification assay results during long term stability testing.
GE Healthcare is recalling 1,221 ViewPoint 6 systems because the Patient History tab in software versions 6.15.3 and 6.15.4 may not include complete patient medical history information.
Novocol Pharmaceutical of Canada is recalling Mepivacaine HCl 3% injection distributed by Benco Dental over a defective container with cracked or broken cartridges.
Somerset Therapeutics is recalling 52,340 vials of Cisatracurium Besylate Injection, 10 mg/5 mL, after out of specification assay results during long term stability testing.
Myofunctional Research Company USA is recalling 436 Myosa for Kids devices because the firm mistakenly distributed the product within the US without FDA premarket clearance or approval.
DSAART is recalling 41 AART Pectoral Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.
Copan Italia is recalling 122,850 units of 1ml DTT reagent supplied with a sputum transfer device because treatment reagent functionality in respiratory specimens liquification cannot be guaranteed.
DSAART is recalling 2 AART Malar Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.
DSAART is recalling 369 AART Silicone Carving Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.
Copan Italia is recalling 122,850 units of 1ml DTT liquid reagent because treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.
Sun Pharma/Taro is recalling 17,664 units of Ciclopirox Shampoo 1% after out of specification impurity and degradation results at the 18-month timepoint.
SeaSpine Orthopedics is recalling 310 NorthStar OCT Navigation items because the surgical technique guide incorrectly identified Medtronic Infinity toolcards as compatible.
Zimmer Surgical is recalling 498 Zimmer Dermatome AN units because the devices may have a misaligned thickness control bar.
Somerset Therapeutics is recalling 28,660 vials of Cisatracurium Besylate Injection, 200mg/20mL, after out of specification assay results during long term stability testing.
Novocol Pharmaceutical of Canada is recalling 18,789 cartons of 2% Xylocaine Dental with Epinephrine over a defective container with cracked or broken cartridges.
Novocol Pharmaceutical of Canada is recalling 5,825 units of 3% Polocaine Dental mepivacaine injection over a defective container with cracked or broken cartridges.
Preferred Pharmaceuticals is recalling 575 blister packs of Ondansetron ODT Tablets, 4mg, after the manufacturer reported that the blister packs are not fully sealed and tablets are falling out.
Instrumentation Laboratory is recalling 4,506 units of HemosIL SynthAFax partial thromboplastin time reagent because the recalled lots were manufactured with double the preservative concentration.
Novocol Pharmaceutical of Canada is recalling 12,033 cartons of Lidocaine HCl 2% with Epinephrine 1:100,000 injection over a defective container with cracked or broken cartridges.
Novocol Pharmaceutical of Canada is recalling 5,520 cartons of Mepivacaine HCl 3% injection over a defective container with cracked or broken cartridges.
Zimmer Surgical is recalling 839 Zimmer Air Dermatomes because the devices may have a misaligned thickness control bar.
Datascope is recalling 11,470 Cardiosave Hybrid units to issue an instructions for use addendum updating the Vibration and Shock Table to reference the correct standards.
Datascope is recalling 47 Cardiosave Rescue units to issue an instructions for use addendum updating the Vibration and Shock Table to reference the correct standards.
Chetak New York is recalling Deep-brand frozen amla slices after the product tested positive for Salmonella. The FDA has classified the action as Class I.
Chetak New York is recalling Deep-brand frozen aviyal mix after the product tested positive for Salmonella. The FDA has classified the action as Class I.