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

3501–3525 of 5063

HighFDA (Drugs)·D-1261-2022·2022-07-27
Ketamine HCl Injection Recalled for Lack of Sterility Assurance
Nephron is recalling 47,905 pre-filled syringes of Ketamine HCl Injection nationwide due to lack of sterility assurance. Users should contact the manufacturer for handling instructions.
Product
Ketamine HCl Injection, USP, 50 mg/1 mL (50 mg/mL*) syringe, packaged in 5 x 1 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-511-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1283-2022·2022-07-27
FDA Recalls Cipla Difluprednate Eye Drops for Defective Container Caps
Cipla is recalling 8,136 bottles of Difluprednate ophthalmic emulsion nationwide due to defective container caps that can break and expose the medication tip, compromising sterility.
Product
DIFLUPREDNATE — DIFLUPREDNATE (DIFLUPREDNATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1256-2022·2022-07-27
HYDROmorphone HCl Injection Syringes Recalled for Sterility Assurance
Nephron Sterile Compounding Center is recalling HYDROmorphone HCl Injection syringes nationwide due to lack of assurance of sterility. The recall affects 12,900 syringes across two manufacturing lots.
Product
HYDROmorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL) syringes, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-529-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1266-2022·2022-07-27
Morphine Sulfate Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center LLC is recalling Morphine Sulfate Injection due to lack of assurance of sterility. The recall affects 8,985 syringes distributed nationwide.
Product
Morphine Sulfate Injection, USP, 30 mg/30 mL (1 mg/mL) syringe, packaged in 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1275-2022·2022-07-27
Phenylephrine HCl injection recalled for lack of sterility assurance
Nephron Sterile Compounding Center recalls Phenylephrine HCl Injection syringes nationwide due to lack of sterility assurance. Patients with affected lots should contact their healthcare provider.
Product
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL)syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-956-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1276-2022·2022-07-27
Nephron Phenylephrine HCl Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center LLC recalls Phenylephrine HCl Injection (1 mg/10 mL) syringes nationwide due to inability to guarantee sterility. Approximately 464,265 syringes across eleven lot numbers are affected.
Product
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-957-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1269-2022·2022-07-27
FDA Recalls Nephron Cardioplegia Solution Over Sterility Assurance Concerns
Nephron Sterile Compounding Center is recalling del Nido Cardioplegia Solution due to lack of assurance of sterility. The 1765 bags affected were distributed nationwide.
Product
del Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag, 4 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-984-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1245-2022·2022-07-27
Nephron Amino Acid Injection Bags Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling 163 bags of Amino Acid Injection due to lack of assurance of sterility. Patients using this intravenous medication should contact their healthcare provider immediately.
Product
Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outsourcing facility, 4500 12th Extension, West Columbia, SC 29172, NDC: 69374-988-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1246-2022·2022-07-27
Atropine Sulfate Injection Recalled Nationwide for Sterility Assurance Failure
Nephron Sterile Compounding Center LLC is recalling Atropine Sulfate Injection pre-filled syringes nationwide due to lack of assurance of sterility affecting approximately 13,340 syringes.
Product
Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-935-03
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1339-2022·2022-07-27
Dietary Supplement Marketed as Unapproved Drug Recalled by FDA
Launch Sequence Capsules, a dietary supplement sold in 60-count bottles, were recalled because they were marketed without FDA approval as a drug based on label claims.
Product
Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1272-2022·2022-07-27
Neostigmine Methylsulfate Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling 64,365 syringes of Neostigmine Methylsulfate Injection nationwide due to lack of assurance of sterility. Patients using affected lots should contact their healthcare provider.
Product
Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-902-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1248-2022·2022-07-27
Injectable Lidocaine Syringes Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center has recalled 1,380 prefilled lidocaine syringes nationwide due to inability to confirm product sterility.
Product
0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL (9 mg/mL) syringes, packaged in 5 x 5 mL Prefilled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC:
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1265-2022·2022-07-27
Morphine Sulfate Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Morphine Sulfate Injection due to lack of assurance of sterility. The recall affects 5,495 pre-filled syringes distributed nationwide.
Product
Morphine Sulfate Injection, USP, 50 mg/50 mL (1 mg/mL) syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1281-2022·2022-07-27
Succinylcholine Chloride Injection Recalled for Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling 18,840 syringes of Succinylcholine Chloride Injection nationwide because the manufacturing process cannot be assured to have maintained sterility.
Product
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-919-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1251-2022·2022-07-27
Epinephrine Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling 134,385 epinephrine injection syringes nationwide due to lack of assurance of sterility. No illnesses have been reported.
Product
EPINEPHrine Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-925-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1270-2022·2022-07-27
Neostigmine Methylsulfate Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center LLC is recalling Neostigmine Methylsulfate Injection due to lack of assurance of sterility. The recall affects 59,520 syringes distributed nationwide.
Product
Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-932-03
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1267-2022·2022-07-27
Morphine Sulfate Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Morphine Sulfate Injection syringes distributed nationwide due to lack of assurance of sterility. Approximately 43,385 syringes are affected.
Product
Morphine Sulfate Injection, USP, 2 mg/2 mL (1 mg/mL) syringe, packaged in 5 x 2 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-02
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1250-2022·2022-07-27
Epinephrine Injection Recalled Due to Sterility Assurance Failure
Nephron is recalling epinephrine injection syringes nationwide due to lack of sterility assurance. No illnesses have been reported to date.
Product
EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL) syringes, 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia SC 29172, NDC: 69374-544-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1263-2022·2022-07-27
Lidocaine HCl Injection Syringes Recalled for Sterility Assurance
Nephron Sterile Compounding Center recalls Lidocaine HCl Injection 2% syringes distributed nationwide due to lack of assurance of sterility. Affected lots should not be used.
Product
Lidocaine HCl Injection, USP 2%, 100 mg/5 mL (20 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-949-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1259-2022·2022-07-27
Ketamine HCl Injection Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Ketamine HCl Injection due to lack of sterility assurance. The recall affects 91,445 pre-filled syringes distributed nationwide.
Product
Ketamine HCl Injection, USP, 50 mg/5 mL (10 mg/mL*) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-55
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1279-2022·2022-07-27
Sodium Bicarbonate Injection USP recalled for lack of sterility assurance
Nephron Sterile Compounding Center recalls 36,354 pre-filled syringes of Sodium Bicarbonate Injection due to lack of sterility assurance. The medication was distributed nationwide.
Product
8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syringe, packaged in 1 x 50 mL Pre-Filled Syringe per carton, 30 x 1 syringe carton per case, Rx Only Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1268-2022·2022-07-27
Morphine Sulfate Injection Recalled Due to Sterility Assurance Concerns
Nephron Sterile Compounding Center LLC is recalling morphine sulfate injection syringes due to lack of assurance of sterility. The recall affects 4,620 pre-filled syringes distributed nationwide.
Product
Morphine Sulfate Injection, USP, 1 mg/mL syringe, packaged in 5 x 1 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1280-2022·2022-07-27
Anticoagulant Sodium Citrate Solution Recalled for Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling 85,300 pre-filled syringes of Anticoagulant Sodium Citrate Solution due to failure to assure sterility. Affected patients should contact their healthcare provider.
Product
Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-906-05
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1273-2022·2022-07-27
Oxytocin Injectable Recalled Due to Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling Oxytocin 30 Units/500 mL injectable solution due to lack of sterility assurance. Approximately 1,810 bags with lot codes OX2013C and OX2013E were distributed nationwide.
Product
Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP IV bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-543-50
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1257-2022·2022-07-27
HYDROmorphone Injection Recalled Due to Lack of Sterility Assurance
HYDROmorphone HCl Injection 30 mg/30 mL from Nephron Sterile Compounding Center LLC is being recalled nationwide due to lack of assured sterility. The recall affects 18,570 syringes across three lot numbers.
Product
HYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) syringe, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-30
Category
Drug
Distribution
Distributed nationwide

How to read this listing

Filters

3501–3525 of 5063