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

2576–2600 of 17964

ModerateFDA (Drugs)·D-0799-2023·2023-06-07
Dicyclomine Hydrochloride Injectable Drug Recalled for Manufacturing Quality Deviations
Akorn, Inc. is recalling all lots of Dicyclomine Hydrochloride Injection USP nationwide due to Current Good Manufacturing Practice deviations. The firm went out of business and could not complete required stability studies.
Product
Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0817-2023·2023-06-07
Levocarnitine Oral Solution Recalled Due to Incomplete Stability Studies
Akorn, Inc. has recalled all lots of Levocarnitine Oral Solution, USP (118 mL bottles) because the company ceased operations and could not complete required stability studies due to CGMP deviations.
Product
Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0791-2023·2023-06-07
Cetrorelix Acetate Injectable Recalled Due to Manufacturing Deviations
Akorn, Inc. recalls all lots of Cetrorelix Acetate for Injection due to manufacturing process deviations. The company went out of business and could not complete required stability testing.
Product
Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophilized powder for reconstitution, 1 pre-filled syringe with diluent, 1 20-gauge needle, 1 27-gauge needle, Sterile - For subcutaneous use only, Rx Only, Manufacture
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0833-2023·2023-06-07
Olopatadine HCl Eye Drops Recalled for Manufacturing Quality Deviations
Akorn, Inc. is recalling all lots of Olopatadine HCl Ophthalmic Solution, USP 0.1% eye drops due to Current Good Manufacturing Practice deviations. The manufacturer discontinued required stability studies after ceasing operations.
Product
Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0782-2023·2023-06-07
Acyclovir Oral Suspension Recalled for Manufacturing Practice Deviations
Akorn's Acyclovir Oral Suspension is being recalled nationwide due to manufacturing practice deviations. The firm closed and could not complete required stability studies for the medication.
Product
Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0856-2023·2023-06-07
XOPENEX Inhalation Solution Recalled Due to Manufacturing Compliance Issues
Akorn, Inc. is recalling all lots of XOPENEX (levalbuterol HCl) inhalation solution because the company went out of business and cannot continue required stability studies. The firm's manufacturing deviations affect product safety verification.
Product
XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0842-2023·2023-06-07
Ropivacaine Hydrochloride Injection Recalled Due to Incomplete Stability Studies
Akorn, Inc. is recalling all lots of Ropivacaine Hydrochloride Injection USP 0.5% nationwide due to incomplete stability studies. The manufacturer ceased operations and could not continue required FDA testing.
Product
Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0801-2023·2023-06-07
Docusate Liquid Drug Recalled Over Incomplete Stability Testing
Akorn, Inc. is recalling all lots of DOCU LIQUID (docusate sodium) after the company ceased operations and could not complete mandatory stability testing required for FDA compliance.
Product
DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0829-2023·2023-06-07
Moxifloxacin HCl Ophthalmic Solution Recalled Due to CGMP Compliance Deviation
Moxifloxacin HCl Ophthalmic Solution 0.5% is being recalled because manufacturer Akorn, Inc. ceased operations and cannot complete required stability studies. All lots distributed nationwide in the USA and Puerto Rico are affected.
Product
Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0781-2023·2023-06-07
Acetic Acid Otic Solution recalled due to manufacturing deviations and unverified stability
Akorn is recalling all lots of Acetic Acid Otic Solution nationwide due to manufacturing practice deviations. The firm went out of business and could not complete stability studies required to verify the product remained safe and effective.
Product
Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0665-2023·2023-05-31
Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services, Inc. is recalling 48 bags of Cardioplegia Solution after an FDA inspection found the manufacturer could not assure the product's sterility. The product was distributed nationwide.
Product
Cardioplegia Solution, Induction 8:1 High Potassium/low dextrose, 100 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0107-1.
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-0753-2023·2023-05-31
Lidocaine Injectable Solution Recalled for Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling Lidocaine 2% HCl Injectable Solution nationwide due to lack of sterility assurance following an FDA inspection. The recall affects 1,516 bags distributed across the United States.
Product
Lidocaine 2% HCl Inj, 500mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8091-1, code 7128580911.
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-0705-2023·2023-05-31
Oxytocin and Lactated Ringer's Injection Recalled for Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 560 bags of oxytocin 15 units in Lactated Ringer's 250 mL after FDA inspection questioned the sterility of these products.
Product
oxyTOCIN 15 units added to Lactated Ringer's 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6037-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0674-2023·2023-05-31
Cardioplegia Solution Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services recalls 208 bags of Cardioplegia Solution nationwide due to sterility assurance concerns identified during an FDA inspection.
Product
Cardioplegia Solution, Modified St Thomas Formula, low potassium, 70 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0210-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0727-2023·2023-05-31
FDA Recalls Phenylephrine Injectable Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling 5,304 bags of phenylephrine injection nationwide after FDA inspection raised concerns about product sterility assurance.
Product
PHENYLephrine added to 0.9% sodium chloride, 25 mg/250 mL* (100 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7011-1.
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-0695-2023·2023-05-31
Neonatal TPN Starter Bags Recalled for Unassured Sterility
Central Admixture Pharmacy Services is recalling 135 bags of neonatal TPN starter bags distributed nationwide because the FDA found inadequate assurance of sterility during inspection.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10% with low 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 71285-0425-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0709-2023·2023-05-31
Injectable oxyTOCIN solution recalled nationwide after sterility assurance questioned
Central Admixture Pharmacy Services is recalling oxyTOCIN 20 units in 0.9% sodium chloride injectable solution nationwide after an FDA inspection raised questions about the products' sterility assurance.
Product
oxyTOCIN 20 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 72185-6043-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0696-2023·2023-05-31
Neonatal TPN Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 259 neonatal TPN bags nationwide due to lack of assurance of sterility following FDA inspection.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with low 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 71285-0427-1.
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-0732-2023·2023-05-31
FDA Recalls Heparin Injectable Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 5,207 bags of heparin injectable nationwide due to an FDA-identified sterility assurance failure. The company cannot guarantee the sterility of affected lot numbers.
Product
heparin added to 0.9% sodium chloride, 5,000 units/500 mL* (10 units/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7023-1.
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-0687-2023·2023-05-31
Neonatal Parenteral Nutrition Starter Bags Recalled for Sterility Concerns
Central Admixture Pharmacy Services is recalling 258 bags of Neonatal TPN Starter Bag due to lack of assurance of sterility following an FDA inspection. The product is distributed nationwide.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with CALCIUM, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0413-1.
Category
Drug
Distribution
Distributed nationwide

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2576–2600 of 17964