Hazard

Lack Of Sterility recalls

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

About this hazard tag

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.

176–200 of 447

HighFDA (Drugs)·D-1078-2023·2023-08-09
Phenylephrine Injection Syringes Recalled Due to Sterility Validation Failure
Central Admixture Pharmacy Services Inc. is recalling 16,971 syringes of phenylephrine injection due to lack of validation data for sterilization processes. The product was distributed nationwide.
Product
PHENYLephrine in 0.9 sodium chloride, 400 mcg /10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0976-2023·2023-08-09
FDA Recalls Oxytocin IV Bags Due to Sterility Assurance Deficiency
Central Admixture Pharmacy Services is recalling oxytocin IV bags nationwide due to insufficient validation of sterilization decontamination processes. The recall affects 6,037 bags distributed across multiple lots.
Product
oxyTOCIN 20 units added to 0.9% sodium chloride 1,000 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6043-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1008-2023·2023-08-09
Neonatal TPN Starter Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls 124 neonatal TPN starter bags nationwide due to lack of sterility assurance from missing decontamination validation data.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0421-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1019-2023·2023-08-09
Cardioplegia Solution Recalled Due to Lacking Decontamination Validation Data
A cardioplegia solution is being recalled nationwide because the manufacturer lacks validation data for decontamination cycles, raising sterility assurance concerns. Affected lots: 36-254401 and 36-257070.
Product
CARDIOPLEGIA SOLUTION, 36 mEq K, Induction 4:1, High Potassium/Low tromethamine, IV Bag, total volume = 500 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0101-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1009-2023·2023-08-09
Neonatal TPN starter bags recalled for lack of sterility assurance
Central Admixture Pharmacy Services is recalling 244 neonatal TPN IV bags due to lack of assurance that the sterility process was validated. The manufacturer lacked adequate validation data for their decontamination cycles.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0431-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0992-2023·2023-08-09
Neonatal TPN Starter Bag Recall Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling Neonatal TPN Starter Bags because sterility cannot be assured and decontamination cycle validation data is lacking. The affected lot (36-254911) was distributed nationwide.
Product
Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0401-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1024-2023·2023-08-09
Cardioplegia solution IV bags recalled for lack of sterility assurance
Central Admixture Pharmacy Services is recalling 308 bags of cardioplegia solution nationwide due to lack of assurance of sterility and insufficient validation data for decontamination cycles.
Product
CARDIOPLEGIA SOLUTION, 48 mEq K, Induction 4:1 in Ringer's, High Potassium, IV Bag, total volume = 522.8 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0206-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0944-2023·2023-08-02
Testosterone Cypionate-Propionate Compounded Injectable Recalled for Sterility Assurance Deficiency
New Vitalis Pharmacy is recalling its Testosterone Cypionate-Propionate injectable medication due to lack of assurance of sterility. The recall affects 102 vials distributed nationwide.
Product
Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 mL Multi-Dose Vial, New Vitalis Pharmacy, 4139 Cadillac Ct, Ste 201, Louisville, KY 40213
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0937-2023·2023-08-02
Oxacillin for Injection Recalled Nationwide for Lack of Sterility Assurance
Sagent Pharmaceuticals is recalling Oxacillin for Injection due to lack of assurance of sterility. The product was distributed to healthcare facilities nationwide.
Product
Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0935-2023·2023-08-02
Oxacillin Injectable Recalled for Failure to Assure Sterility
Sagent Pharmaceuticals is recalling Oxacillin for Injection (1 gram vials, Lot OXG301) due to lack of assured sterility. Approximately 65,710 vials distributed nationwide are affected.
Product
Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0934-2023·2023-07-26
Norepinephrine Injectable Recalled Due to Lack of Sterility Assurance
SterRx recalled 2,088 bags of Norepinephrine 32 mg per 250 mL (Lot #490100) distributed nationwide due to lack of sterility assurance. The recall affects a critical care medication used in intensive care settings.
Product
Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-702-01.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0931-2023·2023-07-26
Norepinephrine injectable recalled due to sterility assurance concerns
SterRx is recalling norepinephrine injections due to lack of assurance of sterility. The recall affects 132,299 bags distributed nationwide.
Product
Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-552-01.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0716-2023·2023-05-31
IV Potassium Phosphate Solution Recalled Due to Sterility Concerns
Central Admixture Pharmacy Services recalls 9,432 bags of potassium phosphate injectable solution nationwide following FDA inspection findings that questioned the sterility of these pharmaceutical products.
Product
potassium phosphate 15 mmole 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 71285-6060-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0666-2023·2023-05-31
Cardioplegia Solution Recalled Nationwide for Sterility Assurance Concerns
Central Admixture Pharmacy Services recalls 613 bags of cardioplegia solution nationwide due to FDA inspection concerns about sterility assurance.
Product
Cardioplegia Solution, Induction 4:1 Plasma-Lyte/Tromethamine, High Potassium, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0111-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0762-2023·2023-05-31
Nafcillin for Injection recalled nationwide for lack of sterility assurance
Sagent Pharmaceuticals is recalling Nafcillin for Injection, USP due to lack of assurance of sterility. Approximately 2.2 million vials distributed nationwide are affected.
Product
Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0683-2023·2023-05-31
Neonatal TPN Starter Bag Recalled for Sterility Assurance Issues
Central Admixture Pharmacy Services recalls 558 bags of Neonatal TPN Starter Bag nationwide due to lack of sterility assurance identified during an FDA inspection.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with CALCIUM, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0405-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0707-2023·2023-05-31
Injectable Oxytocin Lactated Ringer's Solution Recalled for Sterility Concerns
Central Admixture Pharmacy Services is recalling 21,871 bags of injectable oxytocin mixed with Lactated Ringer's solution nationwide due to sterility assurance failures identified during an FDA inspection.
Product
oxyTOCIN 30 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 71285-6039-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0722-2023·2023-05-31
Vancomycin Injectable Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services recalls 9,037 bags of vancomycin injectable due to FDA concerns about sterility assurance. Products distributed nationwide may not meet required sterility standards.
Product
vancomycin added to 0.9% sodium chloride, 1.5 g/250 mL* (6 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6076-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0694-2023·2023-05-31
Neonatal TPN Starter Bags recalled due to sterility assurance concerns
Central Admixture Pharmacy Services is recalling 128 bags of Neonatal TPN Starter Bag after FDA inspection raised concerns about sterility assurance. The product is used for intravenous nutritional support in newborns.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0423-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0691-2023·2023-05-31
Neonatal Injectable TPN Bags Recalled Over Sterility Assurance Concerns
Central Admixture Pharmacy Services recalled 877 bags of neonatal TPN starter bags nationwide due to lack of sterility assurance following an FDA inspection.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0420-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0733-2023·2023-05-31
Phenylephrine Injectable Solution Recalled Over Sterility Assurance Failure
Central Admixture Pharmacy Services recalls 13,953 bags of phenylephrine injectable solution nationwide due to FDA concerns about sterility assurance identified during inspection.
Product
PHENYLephrine added to 0.9% sodium chloride, 20 mg/250 mL* (80 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7025-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0711-2023·2023-05-31
Oxytocin Injectable Drug Recalled Over Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 1,332 bags of oxytocin injectable solution due to FDA concerns about sterility assurance. The company could not confirm the product met sterility standards after an FDA inspection.
Product
oxyTOCIN 60 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6045-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0680-2023·2023-05-31
Cardioplegia Solution Recalled Nationwide Due to Unverified Sterility
Central Admixture Pharmacy Services is recalling 79 bags of Cardioplegia Solution nationwide because an FDA inspection found that the sterility of the product could not be assured.
Product
Cardioplegia Solution, LEESBURG CARDIOPLEGIA, packaged in 1030.2 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0218-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0725-2023·2023-05-31
Vancomycin Sodium Chloride Injection Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 11,338 bags of vancomycin sodium chloride injection nationwide due to FDA concerns about product sterility following an inspection.
Product
vancomycin added to 0.9% sodium chloride, 1.5 g/500 mL* (3 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6176-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0712-2023·2023-05-31
dilTIAZem Injectable Bags Recalled Nationwide for Sterility Concerns
Central Admixture Pharmacy Services is recalling 1,230 bags of dilTIAZem injectable due to lack of sterility assurance following FDA inspection. Affected lots were distributed nationwide.
Product
dilTIAZem added to dextrose 5%, 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 72185-6054-1.
Category
Drug
Distribution
Distributed nationwide