Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

2501–2525 of 5063

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-0692-2023·2023-05-31
Neonatal TPN Starter Bags Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 427 bags of Neonatal TPN Starter Bag due to FDA concerns about sterility assurance. An FDA inspection questioned whether the product met required sterility standards.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/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 71285-0421-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0743-2023·2023-05-31
NORepinephrine Injectable Solution Recalled for Sterility Assurance Failure
Central Admixture Pharmacy Services recalls 2890 bags of NORepinephrine injection due to lack of sterility assurance following FDA inspection. The product, distributed nationwide, has affected lots with expiration dates through July 2023.
Product
NORepinephrine added to dextrose 5%, 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 71285-8095-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0724-2023·2023-05-31
FDA Recalls Injectable Phenylephrine Solution Due to Sterility Assurance Issue
Central Admixture Pharmacy Services is recalling 14,205 bags of injectable phenylephrine solution nationwide following FDA inspection findings regarding sterility assurance. The product is prescription-only with nationwide distribution.
Product
PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6092-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0720-2023·2023-05-31
Injectable Vancomycin Admixture Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 27,780 bags of vancomycin injectable solution nationwide after an FDA inspection raised concerns about the product's sterility assurance.
Product
vancomycin added to 0.9% sodium chloride, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6074-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0662-2023·2023-05-31
Cardioplegia Solution Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling Cardioplegia Solution nationwide due to lack of assurance of sterility after an FDA inspection questioned the product's sterility.
Product
Cardioplegia Solution, Maintenance 4:1 low potassium/low tromethamine, 36 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0104-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0669-2023·2023-05-31
Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls Cardioplegia Solution (182 bags, nationwide distribution) due to lack of sterility assurance identified during FDA inspection.
Product
Cardioplegia Solution, Modified St Thomas Solution, low potassium, HIGH SODIUM BICARBONATE, 62 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0203-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0690-2023·2023-05-31
Neonatal TPN Starter Bags Recalled Over Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 418 bags of neonatal TPN starter bags nationwide due to loss of sterility assurance following FDA inspection. The prescription product contains amino acids, dextrose, calcium, and heparin.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% 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 71285-0419-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0741-2023·2023-05-31
Tromethamine Injectable Syringes Recalled Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling 225 syringes of tromethamine 0.3 Molar nationwide due to lack of sterility assurance identified during an FDA inspection. No illnesses have been reported.
Product
tromethamine 0.3 Molar, 50 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8086-2.
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-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-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
HighFDA (Drugs)·D-0670-2023·2023-05-31
Cardioplegia Solution Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services, Inc. is recalling cardioplegia solution for lack of assurance of sterility. FDA inspection questioned the sterility of this injectable product; 241 bags were distributed nationwide.
Product
Cardioplegia Solution, Modified St Thomas Solution, HIGH POTASSIUM, HIGH SODIUM BICARBONATE, 106 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0204-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0714-2023·2023-05-31
FDA Recalls Norepinephrine Injection Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 2,041 bags of norepinephrine injection nationwide due to FDA concerns about product sterility. Healthcare providers should immediately stop using affected lots.
Product
norepinephrine 4 mg added to dextrose 5% 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 71285-6056-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0758-2023·2023-05-31
Glimepiride Tablets recalled due to manufacturing practice deviations
Amerisource Health Services is recalling 105,361 bottles of Glimepiride Tablets nationwide following FDA discovery of manufacturing practice deviations. No illnesses have been reported.
Product
Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 68001-178-03 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. For BluePoint Laboratories
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-0654-2023·2023-05-31
FDA Recalls Cardioplegia Solution Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to lack of sterility assurance. An FDA inspection questioned sterility of 254 bags distributed nationwide.
Product
Cardioplegia Solution, Reperfusate 4:1 low potassium/low tromethamine, 15 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0009-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0664-2023·2023-05-31
Cardioplegia Solution Recalled Due to Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling Cardioplegia Solution (Induction 4:1 High Potassium) due to lack of sterility assurance following an FDA inspection. The recall affects 84 bags distributed nationwide.
Product
Cardioplegia Solution, Induction 4:1 High Potassium, 30 mEq K, packaged in 415 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0106-1.
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-0719-2023·2023-05-31
Vancomycin Dextrose Injectable Recalled Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling 13,772 bags of vancomycin-dextrose injectable distributed nationwide after an FDA inspection questioned its sterility assurance. No illnesses have been reported.
Product
vancomycin added to dextrose 5%, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6073-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0764-2023·2023-05-31
Nafcillin for Injection Recalled Nationwide for Lack of Sterility Assurance
Sagent Pharmaceuticals has recalled Nafcillin for Injection due to lack of sterility assurance. The recall affects approximately 370,200 bottles distributed nationwide.
Product
Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0717-2023·2023-05-31
Vancomycin injection recalled due to sterility assurance concerns
Central Admixture Pharmacy Services is recalling vancomycin injections (1 g/250 mL) nationwide due to concerns about sterility assurance identified during FDA inspection. The recall affects 4,390 bags.
Product
vancomycin added to 0.9% sodium chloride, 1 g/250 mL* (4 mg/mL), 25 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6064-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0737-2023·2023-05-31
Diphenhydramine 25 mg intravenous bags recalled for lack of sterility assurance
Central Admixture Pharmacy Services recalls 5,627 bags of diphenhydramine 25 mg intravenous solution nationwide. An FDA inspection called into question the sterility of the products intended to be sterile.
Product
diphenhydrAMINE 25 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 71285-7089-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0651-2023·2023-05-31
Cardioplegia Solution Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling Cardioplegia Solution (Reperfusate No Potassium) due to lack of assurance of sterility identified during FDA inspection.
Product
Cardioplegia Solution, Reperfusate No Potassium, packaged in 477.5 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0006-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0765-2023·2023-05-31
Pain Reliever Caplets Recalled Due to Out-of-Specification Impurity
Aurobindo Pharma is recalling 87,360 bottles of Pain Reliever Acetaminophen caplets (500 mg) distributed nationwide through Walgreens due to failed impurity specifications discovered through customer complaints about discoloration.
Product
PAIN RELIEVER — PAIN RELIEVER (ACETAMINOPHEN)
Category
Drug
Distribution
Distributed nationwide

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2501–2525 of 5063