Hazard
1,417 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 1,417 lack of sterility recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,048 (74%) are Severe.
Which agencies issued them
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all lack of sterility recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.
A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.
Thrive Health Solutions is recalling Tirzepatide Injections 30mg/mL pre-filled syringes due to lack of assurance of sterility. The affected product was distributed nationwide.
Fresenius Medical Care is recalling 0.9% Sodium Chloride Injection in flexible plastic containers nationwide due to lack of assurance of sterility. The FDA classified this as a Class II recall.
Thrive Health Solutions is recalling Semaglutide 2.5 mg/mL pre-filled syringes (Lot #H270221) because the manufacturer cannot assure sterility of the product.
Thrive Health and Wellness, LLC is recalling LL Bioboost Injectable pre-filled syringes nationwide due to lack of assurance of sterility. The affected product is Lot #H277639 with expiration 6/25/2025.
Thrive Health Solutions is recalling NAD+ 100mg/mL pre-filled syringes (Lot GA37484) because the manufacturer cannot assure the product is sterile. The product was distributed nationwide.
Empower Pharmacy is recalling Testosterone Cypionate Injection 200 mg/mL (Lot 202364, 8,230 vials) distributed nationwide because the manufacturer cannot assure the product's sterility. Consumers should stop using the product and consult their healthcare provider.
Amerisource Health Services LLC is recalling Haloperidol Decanoate Injection vials nationwide because some media fill units showed bacterial contamination, indicating a lack of sterility assurance. The affected product is a 100mg/mL injectable antipsychotic medication.
Denver Solutions, LLC (DBA Leiters Health) is recalling Glycopyrrolate 1mg/5mL single-dose syringes (Lot #2431015B, expiration 4/10/2025) distributed nationwide because some syringes were found to be leaking or damaged, which compromises sterility assurance.
Avanos Medical is recalling Ballard Closed Suction Catheters (Model 210, 10 F Elbow) for neonates and pediatric patients due to lack of sterility assurance. Approximately 4,000 units were distributed worldwide.
Avanos Medical is recalling 1,420 units of Ballard Closed Suction Catheters (Model 2271418-5) due to lack of sterility assurance. The affected product was distributed worldwide, including across the US and internationally.
Somerset Therapeutics is recalling Haloperidol Decanoate Injection (100 mg/mL, 1 mL vials) due to lack of assurance of sterility caused by bacterial contamination detected in media fill testing.
Exela Pharma Sciences is recalling Sodium Bicarbonate 8.4% Injection due to lack of sterility assurance. The recall affects approximately 103,950 vials nationwide.
REGENER-EYES ophthalmic solution is being recalled nationwide due to lack of sterility assurance. Consumers should stop using affected lots immediately.
Regener-Eyes ophthalmic solution is being recalled due to lack of sterility assurance. Approximately 170,812 bottles distributed nationwide are affected.
Empower Pharmacy is recalling a pyridoxine (B6) injection solution because sterility assurance could not be confirmed. The recalled product is lot 609763 with a beyond-use date of 04/18/2025.
ProRx LLC is recalling 1,960 vials of compounded semaglutide nationwide due to lack of assurance of sterility. The multiple-dose vials may not meet sterility standards for injectable medications.
ProRx LLC is recalling 37 vials of compounded Tirzepatide injectable due to lack of sterility assurance. The 2 mL vials (10 mg/mL and 20 mg/mL) were distributed nationwide.
Imprimis NJOF, LLC is recalling Epinephrine-Lidocaine preservative-free intraocular injection vials (74,440 units) nationwide due to lack of sterility assurance.
Imprimis NJOF, LLC is recalling Dexamethasone-Moxifloxacin-Ketorolac intraocular injections (38,060 vials) due to lack of assurance of sterility. The affected lots were distributed nationwide.
Imprimis NJOF, LLC is recalling specific lots of Moxifloxacin intraocular injections nationwide due to lack of assurance of sterility.
IntegraDose Compounding Services LLC is recalling 187 cassettes of fentanyl citrate 2,500 mcg/50mL due to leaking bags that compromise sterility. Lot 20231020FEN-1 was distributed nationwide and expired April 17, 2024.
SCA Pharmaceuticals is recalling 368 bags of vancomycin 1.25 g injectable nationwide because the company cannot assure sterility was maintained. The affected lot was distributed across the USA.
SCA Pharmaceuticals is recalling HYDROmorphone HCl injectable syringes nationwide due to lack of sterility assurance. The FDA issued this Class II recall affecting multiple lot numbers.
SCA Pharmaceuticals is recalling Phenylephrine HCl Injectable (400 mcg/10 mL) distributed nationwide due to lack of sterility assurance. Affected lot numbers have expiration dates through May 2024.
SCA Pharmaceuticals is recalling 324 syringes of fentanyl/bupivacaine epidural injection nationwide due to lack of sterility assurance. Patients should contact their healthcare provider if affected.