Severity 4 of 5
The hazard poses a serious risk of illness, injury, or structural failure. 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.
Wellness Pharmacy is recalling Methyl B12 1 mg/mL single-use vials because laboratory results indicated microbial contamination and the FDA questioned the reliability of the testing.
Beacon Hill Medical Pharmacy is recalling Triptropin Plus Injectable because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.
Beacon Hill Medical Pharmacy is recalling Sodium Bicarbonate PF 8.4% Injectable due to FDA inspectional findings regarding quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling Testosterone Hypoallergenic and Testosterone Aqueous injectables due to FDA inspectional findings regarding sterility assurance.
Beacon Hill Medical Pharmacy is recalling Quad Amino Blend 150/75/150/75 mg/mL Injectable due to FDA inspectional findings regarding sterility assurance.
Wellness Pharmacy is recalling 590 vials of Magnesium Sulfate Hepta 50% PF due to laboratory results indicating microbial contamination and concerns about the reliability of testing.
Beacon Hill Medical Pharmacy is recalling all presentations of Magnesium Chloride Hexahydrate 20% Injectable due to FDA inspectional findings regarding quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling Estradiol Cypionate/Progesterone/Testosterone Cypionate injections due to FDA inspectional findings regarding sterility assurance.
Siemens Healthcare Diagnostics is recalling MicroscanrapID/S panels due to confirmed false susceptible and intermediate results for imipenem and meropenum.
Siemens Healthcare Diagnostics is recalling Microscan rapID/S panels due to confirmed false susceptibility and intermediate misreads for imipenem and meropenum.
Beacon Hill Medical Pharmacy is recalling Estriol 5 mg/mL oil injection solution because FDA inspections raised concerns about sterility assurance and quality control.
Reaction Nutrition LLC is recalling 600 bottles of Clinical LIVE Immune Support capsules because they contain undeclared colostrum, a dairy allergen.
Spartan Motors is recalling 75 model year 2011-2013 Transit Bus Chassis Cab vehicles because front suspension control arms may fracture without warning, increasing crash risk.
The FDA is recalling Monoject 100 Units/mL Heparin Lock Flush syringes because they may contain non-sterile water while labeled as saline or heparin.
Beacon Hill Medical Pharmacy is recalling EDETATE DISODIUM 150 MG/ML INJECTABLE because FDA inspectional findings raised concerns about quality control procedures impacting sterility assurance.
Beacon Hill Medical Pharmacy is recalling Calcium Chloride 100 mg/mL Injectable because FDA inspectional findings raised concerns about quality control procedures that impacted sterility assurance.
Beacon Hill Medical Pharmacy is recalling compounded progesterone and testosterone injections due to FDA inspectional findings regarding sterility assurance.
Beacon Hill Medical Pharmacy is recalling compounded Nandrolone Decanoate injections due to FDA inspectional findings regarding sterility assurance.
Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Urine Combo 1 panels due to confirmed false susceptible and intermediate results for imipenem and meropenum.
Beacon Hill Medical Pharmacy is recalling MIC-CARN MAX injectable due to FDA inspectional findings regarding quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling Acetylcysteine 100 mg/mL injection solution because FDA inspectional findings raised concerns about quality control and sterility assurance.
Beacon Hill Medical Pharmacy is recalling Hydroxocobalamin (Vitamin B12A) 1 mg/mL injectable products due to FDA inspectional findings regarding quality control and sterility assurance.
Wellness Pharmacy is recalling Phenylbutyrate 200 mg/mL vials because laboratory results indicate microbial contamination and the FDA has concerns about the reliability of the testing data.
Creative Compounds is recalling 16 vials of Glutathione 100 mg/mL Injectable due to out-of-specification results and potential bacterial contamination.
Beacon Hill Medical Pharmacy is recalling Hydroxyprogesterone Caproate 250 mg/mL oil injection due to sterility assurance concerns identified during an FDA inspection.