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

2001–2025 of 3644

HighFDA (Drugs)·D-0785-2023·2023-06-07
Artificial Tears Solution Recalled Due to CGMP Deviations and Incomplete Stability Studies
Akorn, Inc. is recalling all lots of Artificial Tears Solution (Polyvinyl Alcohol 1.4%) nationwide due to CGMP compliance issues and inability to complete required stability studies after the firm went out of business.
Product
Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0839-2023·2023-06-07
Proparacaine HCl Ophthalmic Solution Recalled Due to Incomplete Stability Studies
Akorn, Inc. is recalling all lots of Proparacaine HCl Ophthalmic Solution 0.5% due to manufacturing deviations. The manufacturer could not complete required stability studies before going out of business.
Product
Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0823-2023·2023-06-07
Lidocaine HCl Jelly 2% recalled nationwide for manufacturing compliance deviations
Akorn, Inc. is recalling all lots of Lidocaine HCl Jelly USP 2% in 5mL tubes nationwide due to manufacturing quality control violations. The company ceased operations and could not complete required stability testing.
Product
Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0854-2023·2023-06-07
Valproic Acid Oral Solution Recalled for Manufacturing Compliance Deviation
Akorn, Inc. is recalling all lots of Valproic Acid Oral Solution, USP (250mg/5mL) nationwide. The recall was issued because the firm ceased operations and could not complete required stability studies as mandated by manufacturing regulations.
Product
Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0807-2023·2023-06-07
Akorn Guaiatussin AC Sugar-Free Cough Suppressant Recalled Due to Manufacturing Deviations
Akorn, Inc. is recalling all lots of Guaiatussin AC Sugar-Free nationwide due to manufacturing deviations. The firm went out of business and could not continue stability studies.
Product
Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg), Codeine Phosphate (10 mg), Alcohol (3.5% v/v), a) packaged in a) 118 mL bottles, b) 473 mL bottles and c) 100 unit dose cups, Rx Only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0811-2023·2023-06-07
Akorn Hydromorphone Hydrochloride Injection Recalled Due to CGMP Deviations
Akorn, Inc. is recalling all lots of Hydromorphone Hydrochloride Injection due to CGMP deviations. The firm went out of business and could not complete required stability testing.
Product
Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1 mL ampules, b) 5 mL ampules, c) 50 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0802-2023·2023-06-07
Ephedrine Sulfate Injection Recalled Due to Incomplete Stability Studies
Akorn, Inc. is recalling all lots of Ephedrine Sulfate Injection due to manufacturing compliance deviations; the firm was unable to complete required stability studies.
Product
Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0780-2023·2023-06-07
Acetaminophen & Codeine Oral Solution Recalled Due to Unverified Stability
Akorn, Inc. is recalling all lots of Acetaminophen & Codeine Oral Solution because stability studies cannot be completed. The firm ceased operations and cannot verify the medication's potency and safety.
Product
Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0773-2023·2023-06-07
Colic Calm Homeopathic Medicine Recalled for Manufacturing Contamination
Denison Pharmaceuticals is recalling Colic Calm, a homeopathic medicine, due to non-food grade lubricant used in the mixing vessel during manufacturing. Affected lot 8290V was distributed nationwide.
Product
Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0837-2023·2023-06-07
Promethazine HCl & Codeine Phosphate Oral Solution Recalled Due to Manufacturing Compliance Deviations
Akorn Inc. is recalling all lots of Promethazine HCl & Codeine Phosphate Oral Solution nationwide because the firm went out of business and cannot complete required stability studies.
Product
Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0820-2023·2023-06-07
Levofloxacin Ophthalmic Solution Recalled Due to Manufacturing Practice Deviations
Akorn, Inc. is recalling all lots of Levofloxacin Ophthalmic Solution 0.5% due to manufacturing practice deviations. The firm went out of business and could not continue required stability studies.
Product
Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0830-2023·2023-06-07
Naloxone Injection Recall Due to Manufacturing Process Deviations
Akorn, Inc. is recalling all lots of Naloxone Injection 0.4 mg/mL due to manufacturing process deviations. The manufacturer could not complete required stability studies.
Product
Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1 mL vials, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0814-2023·2023-06-07
Akorn Lactulose Solution Recalled Due to Incomplete Stability Studies
Akorn, Inc. is recalling all lots of Lactulose Solution USP (Oral), 10g/15mL, distributed nationwide in the USA and Puerto Rico, due to the manufacturer's inability to complete required stability studies following company closure.
Product
Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30 mL bottles, c) 473 mL bottles, and d) 946 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0800-2023·2023-06-07
Diuril Injectable Drug Recalled Due to Manufacturing Quality Deviations
Akorn, Inc. is recalling all lots of Diuril (chlorothiazide sodium) Injection, 500mg/vial, distributed nationwide, due to manufacturing deviations. The manufacturer went out of business and was unable to complete required stability studies.
Product
Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0846-2023·2023-06-07
Akorn Recalls All Lots of Sodium DIURIL Injectable Due to CGMP Deviations
Akorn Operating Company recalls all lots of Sodium DIURIL (chlorothiazide sodium) 0.5g/vial due to Current Good Manufacturing Practice deviations. The manufacturer was unable to complete required stability studies after the firm ceased operations.
Product
Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0672-2023·2023-05-31
Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling its Cardioplegia Solution after an FDA inspection raised concerns about product sterility. The recall affects 333 bags distributed nationwide.
Product
Cardioplegia Solution, Induction 4:1 in Ringer's, HIGH POTASSIUM, 48 mEq K, packaged in 522.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0206-1.
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
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-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-0702-2023·2023-05-31
OxyTOCIN-dextrose injectable recalled nationwide for sterility assurance concerns
Central Admixture Pharmacy Services is recalling oxyTOCIN 20 units in dextrose 5%/Lactated Ringer's solution nationwide due to lack of sterility assurance identified during FDA inspection. 7,595 bags across multiple lot numbers are affected.
Product
oxyTOCIN 20 units added to dextrose 5%/Lactated Ringer's 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6031-1.
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-0700-2023·2023-05-31
Neonatal Parenteral Nutrition Bags Recalled Due to Sterility Concerns
Central Admixture Pharmacy Services recalls 175 bags of neonatal TPN solution nationwide due to FDA inspection findings that questioned the sterility assurance of the product.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4.5%/Dextrose 10% with HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0432-1.
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-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-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

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2001–2025 of 3644