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

301–325 of 673

SevereFDA (Drugs)·D-0763-2022·2022-04-13
FDA Recalls SYMJEPI Epinephrine Injection for Potential Needle Clogging
Adamis Pharmaceuticals is recalling SYMJEPI epinephrine injections due to potential needle clogging that may prevent medication delivery. The FDA has classified this as a Class I recall affecting nationwide distribution.
Product
SYMJEPI (epinephrine injection, USP) 0.3 mg, (0.3 mg/0.3 mL), Two Pre-Filled Single-Dose Syringes per carton, Rx Only, Manufactured for Adamis Pharmaceuticals Corp.; San Diego, CA 92130; Distributed by USWM, LLC., Louisville, KY 40241, Made in Belgium, NDC 78670-130-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0767-2022·2022-04-06
Meclizine Hydrochloride Tablets Recalled Due to Incorrect Label Mix-up
Jubilant Cadista Pharmaceuticals recalls Meclizine Hydrochloride Tablets with incorrect labeling. Bottles labeled as PredniSONE contain Meclizine, risking medication errors.
Product
MECLIZINE HYDROCHLORIDE — MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0750-2022·2022-03-30
Fresenius Kabi Sodium Acetate Injection Recalled for Particulate Matter
Fresenius Kabi USA is recalling sodium acetate injection due to the presence of particulate matter composed of carbon, oxygen, iron, and trace elements in multiple lots distributed nationwide.
Product
SODIUM ACETATE — SODIUM ACETATE (SODIUM ACETATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0724-2022·2022-03-30
Sincalide Injection Recalled for Potency and Reconstitution Issues
Olympia Compounding Pharmacy is recalling Sincalide lyophilized powder for injection due to concerns about super potency and failed reconstitution time. The product is distributed nationwide, including Puerto Rico.
Product
Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg, Arginine 30mg, Lysine 15mg, Potassium Phosphate 9mg, Methionine 4mg, Edetate Disodium Dihydrate 2mg, Polysorbate mcg, Water for Injection, Multiple Dose Injection 5 mcg Vial, Rx Only, Olympia Compou
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0740-2022·2022-03-30
Hand Sanitizer Isopropyl Alcohol Recall Due to Methanol Contamination
Tennessee Technical Coatings is recalling hand sanitizer products due to CGMP deviations. Certain lots were manufactured under the same conditions as a product lot found to contain methanol.
Product
HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings Corporation, 1421 Higgs Road (P.O. Box 1698) Lewisburg, TX 37091, NDC 76921-000-01
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0668-2022·2022-03-30
Blaine Labs Revitaderm Wound Care Gel Recalled for Bacillus Contamination
The FDA has recalled Revitaderm Wound Care gel (Benzalkonium Chloride 0.1%) distributed nationwide due to contamination with Bacillus cereus. The affected product was distributed to 45 doctors in 17 states.
Product
REVITADERM WOUND CARE — REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0739-2022·2022-03-30
Hand Sanitizer Isopropyl Alcohol 75% Contaminated with Methanol
Tennessee Technical Coatings Corporation is recalling one lot of Hand Sanitizer Isopropyl Alcohol Antiseptic 75% (1 U.S. Gallon) due to FDA analysis finding methanol contamination. The product was distributed in Alabama and Tennessee.
Product
HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings Corporation, 1421 Higgs Road (P.O. Box 1698) Lewisburg, TX 37091, NDC 76921-000-01
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0666-2022·2022-03-23
Methylcobalamin Injectable Recalled Due to Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling Methylcobalamin 1 mg/mL Injectable in 1 mL syringes (Lot #07282020@3) distributed in North Carolina because the manufacturer cannot assure the product meets sterility standards.
Product
Methylcobalamin 1 mg/mL Injectable in 1 mL syringes, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0665-2022·2022-03-23
Lorazepam 1 mg/mL Infusion Solution Recalled for Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling Lorazepam 1 mg/mL Infusion Solution in 250 mL bags because the manufacturer cannot assure sterility of the product.
Product
Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0664-2022·2022-03-23
Ketamine 50 mg Infusion Solution Recalled for Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling three bags of Ketamine 50 mg Infusion Solution because the manufacturer cannot assure sterility of the product.
Product
Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0663-2022·2022-03-23
Morphine Sulfate Infusion Recall Due to Sterility Assurance Failure
Family Pharmacy of Statesville is recalling Morphine Sulfate 6 mg/mL infusions in 250 mL bags due to lack of assurance of sterility. The affected product was distributed in North Carolina.
Product
Morphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0661-2022·2022-03-23
Trimix Injectable Vials Recalled for Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling Trimix (Alprostadil/Papaverine/Phentolamine) injectable vials distributed in North Carolina due to lack of assurance of sterility.
Product
Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0659-2022·2022-03-23
Hydromorphone HCl Infusion Recall Due to Sterility Assurance
Family Pharmacy of Statesville is recalling one lot of Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags due to lack of assurance of sterility.
Product
Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0667-2022·2022-03-23
Fentanyl Infusion Solution Recalled for Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling one lot of Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags because the manufacturer cannot assure the product's sterility.
Product
Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0655-2022·2022-03-23
B. Braun 0.9% Sodium Chloride Injection bags recalled for leaking
B. Braun Medical, Inc. is recalling 33,742 bags of 0.9% Sodium Chloride Injection USP due to leaking that compromises sterility assurance. The intravenous medication was distributed nationwide.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0658-2022·2022-03-23
Hydromorphone HCl 5 mg/mL Infusion Recall Due to Sterility Assurance
Family Pharmacy of Statesville is recalling Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags because the manufacturer cannot assure the product meets sterility requirements.
Product
Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0657-2022·2022-03-23
Hydromorphone HCl 1 mg/mL 250 mL Bags Recalled for Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling four bags of Hydromorphone HCl 1 mg/mL (250 mL each) distributed in North Carolina due to lack of assurance of sterility. The affected lots have beyond-use dates of October 25–30, 2020.
Product
Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0662-2022·2022-03-23
Vancomycin Ophthalmic Solution Recalled Due to Sterility Concerns
Family Pharmacy of Statesville is recalling Vancomycin 14 mg/mL Fortified Ophthalmic Solution due to lack of assurance of sterility. The affected lot was distributed in North Carolina.
Product
Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0656-2022·2022-03-23
Hydromorphone HCl Infusion Bags Recalled for Lack of Sterility Assurance
Family Pharmacy of Statesville is recalling Hydromorphone HCl 2 mg/mL Infusion 250 mL bags (2 units) distributed in North Carolina due to lack of assurance of sterility.
Product
Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0725-2022·2022-03-23
Avaphinal Maximum Male Enhancement Pills Recalled for Undeclared Drug
Walmart is recalling Avaphinal Maximum Male Enhancement Sexual Pills (2000 MG, 10-capsule cartons, Lot DK1027) distributed nationwide because they contain undeclared sildenafil, making them an unapproved drug.
Product
Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per carton.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0652-2022·2022-03-16
Oxycodone Hydrochloride Oral Solution Recall Due to Impurity Failure
American Health Packaging is recalling one lot of Oxycodone Hydrochloride Oral Solution due to impurity failure detected at initial testing of the repackaged product.
Product
OXYCODONE HYDROCHLORIDE — OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0645-2022·2022-03-02
RISE UP RED EDITION Capsules recalled for undeclared tadalafil
RISE UP RED EDITION Capsules, 650 mg, have been recalled because they contain undeclared tadalafil, an ingredient found in FDA-approved male sexual enhancement products. The product is an unapproved drug and was distributed nationwide via Amazon Marketplace.
Product
RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0648-2022·2022-02-23
HCG 6,000iu Injection Recalled for Bacterial Contamination
Revive Rx is recalling HCG 6,000iu injectable medication due to bacterial contamination (Paenibacillus lautus) identified in the product. The affected lot was distributed nationwide.
Product
HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vial, Rx Only, Compounded By: Revive Rx 3831 Golf Dr., Houston, TX 77018, NDC: 88888-1739-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0562-2022·2022-02-23
MAC DADDY RED Capsules Recalled for Undeclared Drug Ingredients
MAC DADDY RED Capsules are being recalled because they contain undeclared tadalafil and/or sildenafil without FDA approval. The product was distributed nationwide via Amazon Marketplace.
Product
MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLDZLY2, UPC 742137 605191.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0633-2022·2022-02-23
HYDROmorphone HCl syringe recalled due to labeling mix-up
STAQ Pharma is recalling HYDROmorphone HCl PF syringes (lot 21104221A) that were incorrectly labeled as Morphine Sulfate PF. The mislabeling affects approximately 905 syringes distributed in Colorado, Ohio, and Texas.
Product
HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC: 73177-0104-05.
Category
Drug
Distribution
3 states

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301–325 of 673