Hazard

Sterility Failure recalls

1,691 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 1,691
Critical: 12
Severe: 931
Most recent: 2026-07-29

Of the 1,691 sterility failure recalls we have scored against our rubric, 12 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 931 (55%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility failure 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.

226–250 of 1691

HighFDA (Drugs)·D-0653-2023·2023-05-31
FDA Recalls Cardioplegia Solution Over Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling Cardioplegia Solution, Reperfusate 4:1 due to lack of sterility assurance identified during an FDA inspection. The recall affects 338 bags distributed nationwide.
Product
Cardioplegia Solution, Reperfusate 4:1 low potassium, 15 mEq K, packaged in 477.5 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0008-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0656-2023·2023-05-31
FDA Recalls Microplegia Solution for Sterility Assurance Concerns
Central Admixture Pharmacy Services recalls Microplegia Solution due to sterility assurance concerns identified during an FDA inspection. Affected product should not be used.
Product
Microplegia Solution, MSA/MSG 0.92 Molar with CP2D, packaged in 120 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0012-2.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0748-2023·2023-05-31
Vasopressin Injectable Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling vasopressin 40 units injectable because FDA inspection raised concerns about sterility assurance.
Product
vasopressin 40 units added to 0.9% sodium chloride 100 mL*, 0.4 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9001-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0744-2023·2023-05-31
FDA Recalls NORepinephrine Injection Due to Sterility Concerns
Central Admixture Pharmacy Services recalled 6,414 bags of NORepinephrine injection nationwide after an FDA inspection questioned the sterility of the product. Healthcare facilities should stop using and quarantine affected lots.
Product
NORepinephrine added to 0.9% sodium chloride, 8 mg/250 mL* (32 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8096-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0648-2023·2023-05-31
Microplegia injectable recalled for lack of sterility assurance
Central Admixture Pharmacy Services recalls Microplegia injectable solution due to FDA concerns about sterility assurance. The product was distributed nationwide across the United States.
Product
Microplegia (MSA/MSG 0.92 Molar) packaged in 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0001-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0681-2023·2023-05-31
Cardiac Perfusion Solution Recalled for Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling Modified del Nido Microplegia syringes after an FDA inspection raised concerns about their sterility. Approximately 690 syringes distributed nationwide may be affected.
Product
Modified del Nido Microplegia, packaged in 40 mL per syringe, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0219-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0742-2023·2023-05-31
FDA recalls epinephrine injection for lack of sterility assurance
Central Admixture Pharmacy Services recalled 8171 bags of epinephrine injection nationwide due to FDA concerns about sterility. The recalled prescription-only product was distributed across multiple lot numbers with expiration dates in 2023.
Product
EPINEPHrine added to 0.9% sodium chloride, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8093-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0710-2023·2023-05-31
Oxytocin Injectable Solution Recalled for Sterility Assurance Questions
Central Admixture Pharmacy Services is recalling oxytocin injectable solution after FDA inspection questioned sterility. Over 104,000 bags distributed nationwide are affected.
Product
oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6044-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0678-2023·2023-05-31
Cardioplegia Solution Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services recalls Cardioplegia Solution due to failed sterility assurance after FDA inspection. 363 bags distributed nationwide.
Product
Cardioplegia Solution, Induction 8:1 non-enriched, HIGH POTASSIUM, 70 mEq K, packaged in 300 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0214-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0730-2023·2023-05-31
Prescription Injectable Epinephrine and Dextrose Solution Recalled for Sterility Assurance Failure
Central Admixture Pharmacy Services has recalled nationwide 2,542 bags of prescription-only injectable epinephrine and dextrose solution due to lack of sterility assurance following an FDA inspection.
Product
EPINEPHrine added to dextrose 5%, 8 mg/250 mL* (32 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7019-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0718-2023·2023-05-31
Vancomycin Injectable Solution Recalled Due to Sterility Assurance Concerns Nationwide
Central Admixture Pharmacy Services is recalling 3,075 bags of vancomycin injectable solution nationwide due to lack of assurance of sterility following an FDA inspection.
Product
vancomycin added to 0.9% sodium chloride, 750 mg/250 mL* (3 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6071-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0734-2023·2023-05-31
NORepinephrine Injectable Recalled Nationwide for Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 6,341 bags of NORepinephrine nationwide due to FDA concerns about sterility assurance. An FDA inspection found the manufacturer could not adequately ensure the product's sterility.
Product
NORepinephrine added to 0.9% sodium chloride, 16 mg/250 mL* (64 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7036-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0763-2023·2023-05-31
Nafcillin Injectable Medication Recalled for Sterility Assurance Failure
Sagent Pharmaceuticals is recalling Nafcillin for Injection, USP 2 gram vials nationwide due to lack of assurance of sterility in the manufacturing process. This FDA Class II recall affects multiple lots distributed across the United States.
Product
Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0746-2023·2023-05-31
Heparin Solution Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 2,992 bags of heparin solution nationwide due to failure of sterility assurance discovered during FDA inspection.
Product
heparin added to 0.9% sodium chloride, 2,500 units/500 mL* (5 units/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8100-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0738-2023·2023-05-31
FDA Recalls Diphenhydramine Injectable for Sterility Assurance Deficiency
Central Admixture Pharmacy Services is recalling 3,999 units of diphenhydramine injectable due to sterility assurance concerns identified during an FDA inspection. No illnesses have been reported.
Product
diphenhydrAMINE 50 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7090-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0708-2023·2023-05-31
FDA Recalls Oxytocin Injection Bags Over Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 3,865 bags of oxytocin injection across the USA due to lack of sterility assurance identified during an FDA inspection. Sterile injectables must meet strict standards to prevent infection risk.
Product
oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6042-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0736-2023·2023-05-31
FDA Recalls Vancomycin Injectable Solution Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling 8,252 bags of vancomycin injection nationwide after FDA inspection raised concerns about product sterility. Affected lots expire May through June 2023.
Product
vancomycin added to 0.9% sodium chloride, 1.75 g/500 mL* (3.5 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7060-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0755-2023·2023-05-31
Injectable Drug Recalled for Unverified Sterility After FDA Inspection
Central Admixture Pharmacy Services is recalling 1673 bags of HyperLyte CR Injection due to lack of sterility assurance. An FDA inspection raised questions about whether the product met sterility standards.
Product
HyperLyte CR Injection, 250 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-2, code 7128580942.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0661-2023·2023-05-31
FDA Recalls Cardioplegia Solution for Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling cardioplegia solution due to sterility assurance concerns identified in an FDA inspection. The recall affects 269 bags distributed nationwide.
Product
Cardioplegia Solution, Maintenance 4:1 low potassium, 20 mEq K, packaged in 810 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0103-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0745-2023·2023-05-31
Drug Recall: NORepinephrine Injectable Solution Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling NORepinephrine injectable solution nationwide after an FDA inspection questioned the product's sterility assurance. The recall affects 4,994 bags.
Product
NORepinephrine added to 0.9% sodium chloride, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8097-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0754-2023·2023-05-31
FDA Recalls HyperLyte CR Injection for Lack of Sterility Assurance
The FDA recalled HyperLyte CR Injection because the manufacturer could not assure the product met sterility requirements. The recall affects 554 bags distributed nationwide.
Product
HyperLyte CR Injection, 500 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-1, code 7128580941.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0701-2023·2023-05-31
FDA Recalls Epinephrine Injection Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 3,338 bags of epinephrine injectable solution nationwide. The FDA raised concerns about sterility assurance during an inspection.
Product
EPINEPHrine added to dextrose 5%, 2 mg/250 mL* (8 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6030-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0713-2023·2023-05-31
Injectable Diltiazem Recalled Over Sterility Assurance Concerns from FDA Inspection
Central Admixture Pharmacy Services is recalling 3,040 bags of prescription diltiazem injection after FDA inspection raised concerns about product sterility. The medication was distributed nationwide.
Product
dilTIAZem added to 0.9% sodium chloride, 125 mg/125 mL* (1 mg/mL), 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6055-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0676-2023·2023-05-31
FDA Recalls Cardioplegia Solution Due to Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to FDA concerns about sterility assurance. The recall affects 52 bags distributed nationwide.
Product
Cardioplegia Solution, Induction 4:1 Plasmalyte, HIGH POTASSIUM, HIGH K, packaged in 542 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0212-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0704-2023·2023-05-31
FDA Recalls Oxytocin Injectable Bags Due to Sterility Assurance Failure
FDA recalls 2,989 bags of oxytocin mixed with Lactated Ringer's solution nationwide due to lack of sterility assurance. An FDA inspection raised questions about whether the injectable drug met sterility standards.
Product
oxyTOCIN 10 units added to Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6036-1.
Category
Drug
Distribution
Distributed nationwide