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

2701–2725 of 17964

HighFDA (Drugs)·D-0684-2023·2023-05-31
Neonatal TPN Starter Bag Recalled for Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 71 bags of Neonatal TPN Starter Bag nationwide following an FDA inspection that questioned the product's sterility. The affected lots expire in April and May 2023.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0406-1.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0757-2023·2023-05-31
Nationwide Recall of Glimepiride Tablets for Manufacturing Practice Deviations
Amerisource Health Services LLC recalls 63,335 bottles of Glimepiride Tablets nationwide due to manufacturing practice deviations identified during FDA inspection.
Product
Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-177-03; Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0768-2023·2023-05-31
Fentanyl Buccal Tablets 400mcg missing or incorrect package insert
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 400mcg due to incorrect or missing package inserts in affected cartons distributed nationwide. No illnesses have been reported.
Product
Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-636-28
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0759-2023·2023-05-31
Glimepiride 4 Milligram Tablets Nationwide Recalled for Manufacturing Practice Deviations
Amerisource Health Services LLC is recalling 129,849 bottles of Glimepiride Tablets, USP 4 mg nationwide due to manufacturing practice deviations identified during an FDA inspection. No illnesses have been reported.
Product
Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0767-2023·2023-05-31
Fentanyl Buccal Tablets Recalled for Missing or Incorrect Package Insert
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets (200mcg) due to missing or incorrect package inserts. Patients should contact their healthcare provider if they have affected product.
Product
Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-635-28
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0766-2023·2023-05-31
Fentanyl Buccal Tablets recalled due to missing or incorrect package insert
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 100mcg due to incorrect or missing package inserts in affected cartons. Patients should verify proper labeling or contact their pharmacy.
Product
Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-634-28
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0769-2023·2023-05-31
Fentanyl Buccal Tablets 600mcg Recalled for Incorrect or Missing Package Insert
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 600mcg due to incorrect or missing package inserts in 1,908 units distributed nationwide across multiple lot numbers.
Product
Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-637-28
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0756-2023·2023-05-31
Methylprednisolone Acetate Injectable Suspension recalled for NDC carton labeling error
Amneal Pharmaceuticals recalls Methylprednisolone Acetate Injectable Suspension due to incorrect NDC number on product cartons. The typographical error appears on secondary packaging only; the medication vial itself is unaffected.
Product
Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for Intravenous Use, 1 mL Single Dose Vial, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit, Ahmedabad 382213, India, Amneal Phar
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0770-2023·2023-05-31
Fentanyl buccal tablets recalled due to incorrect or missing package insert
Teva Pharmaceuticals USA Inc is recalling Fentanyl Buccal Tablets 800mcg due to incorrect or missing package inserts. The recall affects 3,032 units distributed nationwide.
Product
Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0591-2023·2023-05-24
Injectable Antibiotic Ampicillin and Sulbactam Recalled Over Sterility Concerns
Ampicillin and Sulbactam for Injection lacks assurance of sterility, posing potential infection risk. The FDA is recalling 419,680 vials distributed nationwide.
Product
Ampicillin and Sulbactam for Injection, USP 3 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-022-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0609-2023·2023-05-24
Cefepime for Injection recalled due to sterility assurance failure
Astral SteriTech's Cefepime for Injection (1 gram per vial, 550,160 vials nationwide) is being recalled due to lack of assurance of sterility.
Product
Cefepime for Injection, USP 1 gram per vial, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-089-02
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0605-2023·2023-05-24
Cefepime for Injection Vials Recalled Over Sterility Concerns
Cefepime for Injection vials are being recalled nationwide due to lack of sterility assurance. The product should not be used and affected individuals should contact their healthcare provider.
Product
Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-058-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0581-2023·2023-05-24
Ampicillin for Injection Recalled Due to Lack of Sterility Assurance
Astral SteriTech is recalling 17,350 vials of Ampicillin for Injection nationwide because the manufacturer cannot assure the product's sterility. Healthcare providers and patients should consult their healthcare provider about exposure.
Product
Ampicillin for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-221-41
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0640-2023·2023-05-24
Vancomycin Injectable Drug Recalled Due to Lack of Sterility Assurance
Apollo Care, LLC is recalling VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The recall affects 1,622 bags distributed in Missouri.
Product
VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-254-25
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0587-2023·2023-05-24
Ampicillin for Injection Recalled Due to Sterility Assurance Defect
Astral SteriTech Private Ltd. is recalling Ampicillin for Injection due to manufacturing controls that cannot assure product sterility. The FDA Class II recall affects approximately 80,850 vials distributed nationwide.
Product
Ampicillin for Injection, USP 1g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-086-02
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0604-2023·2023-05-24
Cefepime for Injection Recalled Due to Lack of Sterility Assurance
Astral SteriTech is recalling 101,550 vials of Cefepime for Injection nationwide because sterility assurance cannot be confirmed.
Product
Cefepime for Injection, USP 1 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-057-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0601-2023·2023-05-24
Ampicillin and Sulbactam Injectable Recalled for Sterility Assurance Defect
The FDA has recalled Ampicillin and Sulbactam for Injection due to lack of assured sterility. Approximately 119,340 vials distributed nationwide within the United States are affected.
Product
Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-081-02
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0618-2023·2023-05-24
Ceftriaxone for Injection Recalled for Lack of Sterility Assurance
Xellia Pharmaceuticals is recalling 739,750 vials of Ceftriaxone for Injection, USP due to lack of assurance of sterility. All affected lots nationwide should not be used.
Product
Ceftriaxone for Injection, USP, 1 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-096-02
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0641-2023·2023-05-24
Vancomycin Injectable Antibiotic Recalled Due to Sterility Concerns
Apollo Care, LLC is recalling VANComycin 1.75 g injectable solution (NDC 71170-194-50) due to lack of assurance of sterility. The recall affects 240 bags distributed in Missouri.
Product
VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-194-50
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0574-2023·2023-05-24
Lorazepam injection vials recalled for elevated impurities and degradation
Hikma Pharmaceuticals is recalling 1,352,475 vials of Lorazepam Injection due to failed quality tests showing elevated degradation compounds. Affected lots were distributed nationwide and in Puerto Rico.
Product
LORAZEPAM — LORAZEPAM (LORAZEPAM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0622-2023·2023-05-24
Piperacillin and Tazobactam Injectable Recalled for Sterility Assurance Issue
Astral SteriTech is recalling 204,860 vials of Piperacillin and Tazobactam for Injection due to lack of assurance of sterility. The FDA classified this as a Class II recall affecting nationwide distribution.
Product
Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-577-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0636-2023·2023-05-24
Vancomycin injection recalled for lack of sterility assurance
Vancomycin 1.5g in 0.9% saline solution being recalled due to lack of assurance of sterility. Product distributed in Missouri with lot numbers AC-016629 and AC-016646.
Product
VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-185-50
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0590-2023·2023-05-24
Ampicillin and Sulbactam Injectable Recalled for Sterility Assurance Failure
Astral SteriTech is recalling 59,040 vials of Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. The product was distributed nationwide.
Product
Ampicillin and Sulbactam for Injection, USP 1.5 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-021-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0633-2023·2023-05-24
Succinylcholine Injection recalled for lack of sterility assurance
Apollo Care, LLC is recalling Succinylcholine Cl Injection due to lack of sterility assurance. The affected lot was distributed in Missouri.
Product
Succinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-020-05
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0619-2023·2023-05-24
Injectable Ceftriaxone Recalled for Lack of Sterility Assurance
Astral SteriTech is recalling 243,825 vials of Ceftriaxone for Injection due to inability to assure sterility. The medication was distributed nationwide and poses a contamination risk.
Product
Ceftriaxone for Injection, USP, 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-097-02
Category
Drug
Distribution
Distributed nationwide

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2701–2725 of 17964