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

976–1000 of 17937

HighFDA (Drugs)·D-0501-2025·2025-07-09
Compounded ketamine multi-dose vials recalled over sterility assurance concerns
Ketamine Hydrochloride Injection 500 mg/5 mL multi-dose vials compounded by Medivant Healthcare are being recalled for lack of assurance of sterility. 14,725 vials are affected.
Product
KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0007-2.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0498-2025·2025-07-09
Compounded preservative-free lidocaine vials lack assurance of sterility
Preservative-free Lidocaine HCl Injection 1%, compounded by Medivant Healthcare, is being recalled for lack of assurance of sterility. 29,700 vials are affected.
Product
LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative-Free, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S Kyrene Rd., Chandler, AZ, 8522
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0502-2025·2025-07-09
Compounded lidocaine with epinephrine vials lack assurance of sterility
Lidocaine HCl Sterile Injection 1% with epinephrine 1:100,000, compounded by Medivant Healthcare, is being recalled for lack of assurance of sterility. 2,825 vials affected.
Product
LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Caudal & Epidural Use, 10 mL Sterile Single-Dose Vial, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0500-2025·2025-07-09
Compounded ketamine injection recalled over lack of sterility assurance concerns
Ketamine Hydrochloride Injection compounded by Medivant Healthcare is being recalled for lack of assurance of sterility after an FDA inspection raised concerns about the sterile manufacturing process.
Product
KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Office Use Only, Compounded Durg by: Medivant Healthcare, 158 S. Kyrene Rd. Chandler, AZ 85226, NDC 81483-0006-0.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0528-2025·2025-07-09
Pitavastatin tablets recalled after failing impurity and degradation specifications
Pitavastatin Tablets 1 mg from AvKARE are being recalled because they failed impurity and degradation specifications. 1,560 bottles are affected.
Product
PITAVASTATIN — PITAVASTATIN (PITAVASTATIN CALCIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0527-2025·2025-07-09
Teva pitavastatin tablets recalled after failing impurity and degradation specifications
Pitavastatin Tablets 1 mg manufactured by Orient Pharma for Teva Pharmaceuticals are being recalled because they failed impurities and degradation specifications. 20,618 bottles affected.
Product
PITAVASTATIN — PITAVASTATIN (PITAVASTATIN CALCIUM)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0507-2025·2025-07-09
Gabapentin Capsules 100 mg recalled for defective blister packaging
The Harvard Drug Group LLC is recalling 23,232 cartons of Gabapentin Capsules 100 mg (Lot# M05205, Exp Date 10/2026) distributed nationwide due to inadequately sealed blister packaging that may compromise product integrity.
Product
GABAPENTIN — GABAPENTIN (GABAPENTIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0508-2025·2025-07-09
Gabapentin capsule bags recalled because blister packaging was inadequately sealed
Gabapentin Capsules 100 mg from Major Pharmaceuticals are being recalled because of a defective container: the blister packaging was inadequately sealed. 3,527 bags are affected.
Product
GABAPENTIN — GABAPENTIN (GABAPENTIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0510-2025·2025-07-09
Metoprolol succinate extended-release tablets failed dissolution testing during stability studies
Metoprolol Succinate Extended-Release Tablets 25 mg are being recalled because they failed dissolution acceptance criteria at the sixth month of long-term stability testing.
Product
METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0529-2025·2025-07-09
Pitavastatin Tablets Recalled for Failed Impurity and Degradation Specifications
AvKARE is recalling Pitavastatin 2 mg tablets nationwide due to failed impurity and degradation specifications. The affected lots do not meet quality standards for chemical purity.
Product
PITAVASTATIN — PITAVASTATIN (PITAVASTATIN CALCIUM)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0526-2025·2025-07-09
Pitavastatin tablets recalled for failed impurities and degradation specifications
Teva Pharmaceuticals is recalling Pitavastatin 2 mg tablets manufactured by Orient Pharma due to failed impurities and degradation specifications.
Product
PITAVASTATIN — PITAVASTATIN (PITAVASTATIN CALCIUM)
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0479-2025·2025-07-02
Semaglutide 2.5 mg/mL pre-filled syringe recall for sterility assurance
Thrive Health Solutions is recalling Semaglutide 2.5 mg/mL pre-filled syringes (Lot #H270221) because the manufacturer cannot assure sterility of the product.
Product
Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0477-2025·2025-07-02
LX Bioboost Plus Pre-filled Syringe Recalled for Sterility Assurance
Thrive Health Solutions is recalling LX Bioboost Plus pre-filled syringes due to lack of assurance of sterility. The affected product is a multi-ingredient injectable formulation distributed nationwide.
Product
LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dexpanthenol 25 mg, Cyanocobalamin 1 mg, L-Arginine HCl 15 mg, L-Carnitine 15 mg, and Lidocaine 1 mg in SWFI), pre-filled syringe, Thrive Health Solutions, 88 Inve
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0491-2025·2025-07-02
Sodium Chloride Injection Recalled for Sterility Assurance Defect
B Braun Medical Inc. is recalling 187,656 containers of 0.9% Sodium Chloride Injection USP due to potential sterility failures caused by pinholes in finger boxes during manufacturing. The defect may allow leaks and compromise the sterile nature of the intravenous medication.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0484-2025·2025-07-02
Tirzepatide Injections recalled due to lack of sterility assurance
Thrive Health Solutions is recalling Tirzepatide Injections 30mg/mL pre-filled syringes due to lack of assurance of sterility. The affected product was distributed nationwide.
Product
Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0474-2025·2025-07-02
Methylcobalamin Injectable Pre-filled Syringe Recalled for Sterility Concerns
Thrive Health Solutions is recalling Methylcobalamin Injectable 10mg/mL pre-filled syringes (Lot #H228307, expiration 12/27/2025) due to lack of assurance of sterility. The affected product was distributed nationwide.
Product
Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0496-2025·2025-07-02
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution Recall
Apotex Corp. is recalling 6,288 bottles of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution nationwide due to lack of assurance of sterility. The affected batch (VC6058, expiration date 10/31/2025) does not meet sterility requirements for ophthalmic use.
Product
BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION — BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION (BRIMONIDINE TARTRATE AND TIMOLOL MALEATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0495-2025·2025-07-02
Azelastine Hydrochloride Ophthalmic Solution Recalled Due to Sterility
Apotex Corp. is recalling Azelastine Hydrochloride Ophthalmic Solution, USP 0.05% due to lack of assurance of sterility. The affected batch was distributed nationwide.
Product
AZELASTINE HYDROCHLORIDE — AZELASTINE HYDROCHLORIDE (AZELASTINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0486-2025·2025-07-02
Tirzepatide/Cyanocobalamin Injectable Recalled Due to Sterility Assurance Failure
Thrive Health Solutions is recalling one lot of Tirzepatide/Cyanocobalamin Injectable pre-filled syringes due to lack of assurance of sterility. The affected product is Lot C03125A distributed nationwide.
Product
Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0490-2025·2025-07-02
Fresenius Sodium Chloride Injection Recall: Lack of Sterility Assurance
Fresenius Medical Care is recalling 0.9% Sodium Chloride Injection in flexible plastic containers nationwide due to lack of assurance of sterility. The FDA classified this as a Class II recall.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0531-2025·2025-07-02
Testosterone Cypionate Injection Recalled Without Approved Application
Advanced Pharmaceutical Technology, Inc. is recalling TESTO-200 (Testosterone Cypionate Injection USP, 200mg/ml) because it was marketed without an approved NDA or ANDA.
Product
TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 South Central Avenue, Elmsford, NY 10523. NDC 57377-200-01
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0494-2025·2025-07-02
Ketorolac Tromethamine Ophthalmic Solution Recalled for Sterility Risk
Apotex Corp. is recalling Ketorolac Tromethamine Ophthalmic Solution 0.5% due to lack of assurance of sterility. The recall affects 87,840 bottles distributed nationwide.
Product
KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0478-2025·2025-07-02
NAD+ Pre-Filled Syringes Recalled for Lack of Sterility Assurance
Thrive Health Solutions is recalling NAD+ 100mg/mL pre-filled syringes (Lot #O-O8A01-25) distributed nationwide due to lack of assurance of sterility. Consumers should not use this product.
Product
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0485-2025·2025-07-02
Tirzepatide/Cyanocobalamin Injectable Syringes Recalled Due to Sterility Assurance
Thrive Health Solutions is recalling Tirzepatide/Cyanocobalamin Injectable 15mg/1mg/mL pre-filled syringes (Lot C03065F) due to lack of assurance of sterility. The product was distributed nationwide in the USA.
Product
Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0475-2025·2025-07-02
CJC-1295 Injectable Pre-filled Syringes Recalled for Sterility Assurance
Thrive Health Solutions is recalling CJC-1295 Injectable 6mg/15mg pre-filled syringes due to lack of assurance of sterility. The affected product was distributed nationwide.
Product
CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Category
Drug
Distribution
Distributed nationwide

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976–1000 of 17937