Severity 4 of 5
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Sun Pharmaceutical Industries is recalling Testosterone Cypionate for Injection due to cGMP deviations and similarity to a previously rejected out-of-specification lot.
Assurance Infusion is recalling specific lots of Testosterone Cypionate 200mg/mL injections due to a lack of sterility assurance. The affected products were distributed nationwide.
Assurance Infusion is recalling specific lots of Baclofen and Hydromorphone injection due to a lack of sterility assurance.
Assurance Infusion is recalling specific lots of TRIMIX injection due to a lack of sterility assurance. The product was distributed nationwide in the United States.
Toyota is recalling 1997-2000 Celica, RAV4, and Supra vehicles because driver air bag inflators may rupture or underinflate in a crash.
Assurance Infusion is recalling specific lots of Buprenorphine and Morphine injection due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling specific lots of multi-drug syringes because they may lack sterility assurance. Patients should contact their healthcare provider for guidance.
Assurance Infusion is recalling BPC-157 vials nationwide because the product lacks sterility assurance.
Trilliant Surgical is recalling 20 Gridlock Ankle Screw Driver Bits because they are out of specification and may fail to retain screws during implant procedures.
Assurance Infusion is recalling 45 vials of Trimix Super injection nationwide due to a lack of sterility assurance.
Assurance Infusion is recalling 20 mL syringes of BUP 15MG/CLON 600MCG/MORP 30MG/ML injection due to a lack of sterility assurance.
Assurance Infusion is recalling Hydromorphone 1mg/mL injection syringes due to a lack of sterility assurance. The product was distributed nationwide in the United States.
Assurance Infusion is recalling specific lots of Hydromorphone 5mg/mL injections because they may lack sterility assurance.
Assurance Infusion is recalling specific lots of Buprenorphine and Hydromorphone injection due to a lack of sterility assurance.
Assurance Infusion is recalling Alprostadil 40 mcg/mL injection vials nationwide due to a lack of sterility assurance.
Assurance Infusion is recalling BUP 20MG/SUF 105MCG/ML Injection in 20 mL syringes due to a lack of sterility assurance. The recall is nationwide.
Assurance Infusion is recalling specific lots of Hydromorphone 2mg/mL injection syringes because of a lack of sterility assurance.
Assurance Infusion is recalling BUP 15MG/CLON 400MCG/ FENT 6000MCG/ML INJ in 20 mL syringes due to a lack of sterility assurance.
Assurance Infusion is recalling specific lots of Ipamorelin 2000mcg/mL injections because they may lack sterility assurance.
Assurance Infusion is recalling specific lots of BUP 40MG/FENT 1200MCG/SUF 400MCG/ML INJ in 20 mL syringes due to a lack of sterility assurance.
Assurance Infusion is recalling 134 vials of Quadmix Forte injection nationwide because the product lacks sterility assurance.
Assurance Infusion is recalling a specific lot of multi-drug injection syringes due to a lack of sterility assurance. The product was distributed nationwide.
Assurance Infusion is recalling specific lots of Autologous Serum 20% Eye Drops because of a lack of sterility assurance.
Assurance Infusion is recalling specific lots of BUP 20MG/CLON 250MCG/FENT 7200MCG/ML Injection due to a lack of sterility assurance.
Assurance Infusion is recalling a specific lot of BAC/FENT/MORP injection due to a lack of sterility assurance. The product was distributed nationwide.