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

1851–1875 of 8589

SevereFDA (Drugs)·D-0149-2020·2019-10-30
Nephron Recalls Fentanyl and Ropivacaine Injection Due to Glass Contamination
Nephron Pharmaceuticals is recalling 615 bags of Fentanyl and Ropivacaine Injection due to potential glass contamination from GMP deviations.
Product
PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-526-20
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0150-2020·2019-10-30
Nephron Amino Acid Injection Recalled for Sterility and Leak Concerns
Nephron Pharmaceuticals is recalling 162 bags of Amino Acid Injection due to lack of sterility assurance and potential leaks.
Product
Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-988-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0147-2020·2019-10-30
Nephron Recalls Fentanyl and Bupivacaine Injection Due to Glass Contamination
Nephron Pharmaceuticals is recalling 1,855 bags of Fentanyl Citrate and Bupivacaine HCl injection due to potential glass contamination.
Product
PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL, Rx Only, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC 69374-0525-25
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0148-2020·2019-10-30
Nephron Recalls Fentanyl and Bupivacaine Injection Due to Glass Contamination
Nephron Pharmaceuticals is recalling 1,370 bags of Fentanyl Citrate and Bupivacaine HCl injection due to potential glass contamination.
Product
PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (500 mcg/312.5 mg)/250 mL, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-530-25
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0151-2020·2019-10-30
Nephron Recalls del Nido Cardioplegia Solution Due to Sterility Concerns
Nephron Pharmaceuticals is recalling 1,047 bags of del Nido Cardioplegia Solution because the bags may leak, compromising sterility.
Product
del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-984-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0126-2020·2019-10-16
Major Infants' Gas Relief Drops Recalled for Microbial Contamination
GCP Laboratories is recalling Major Infants' Gas Relief Drops due to microbial contamination of the non-sterile product.
Product
Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle, Distributed by: Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA. NDC 0904-5894-30
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0128-2020·2019-10-16
Sandoz Recalls Ranitidine Capsules Due to NDMA Impurity Detection
Sandoz is recalling 13,130 bottles of Ranitidine Hydrochloride Capsules 150mg because a trace amount of the impurity NDMA was detected.
Product
Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2855-05
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0127-2020·2019-10-16
Sandoz Recalls Ranitidine Capsules Due to NDMA Impurity
Sandoz is recalling specific lots of Ranitidine Hydrochloride Capsules 150mg because a trace amount of the impurity NDMA was detected.
Product
Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0129-2020·2019-10-16
Sandoz Recalls Ranitidine Capsules Due to NDMA Impurity Detection
Sandoz is recalling Ranitidine Hydrochloride Capsules 300mg because a trace amount of the impurity NDMA was detected.
Product
Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2865-31
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0133-2020·2019-10-16
DrKids Himasal Nasal Saline Recalled for Potential B. cepacia Contamination
Unipharma is recalling DrKids Himasal Natural Nasal Saline Solution vials due to a precautionary measure regarding potential contamination with B. cepacia bacteria.
Product
DrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-Use Vials a) 0.5 mL Each (20 count) UPC 37030244608; b) 1.5 mL Each (20 count) UPC 370302446098, Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0130-2020·2019-10-16
Morton Grove Recalls Prednisolone Sodium Phosphate Oral Solution Due to Impurity Failure
Morton Grove Pharmaceuticals is recalling Prednisolone Sodium Phosphate Oral Solution because it failed impurity specifications for Prednisolone Impurity 14.
Product
Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured By Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053. NDC 60432-212-08
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0106-2020·2019-10-09
KRS Global Biotechnology Recalls Sterile Ophthalmic Solution Due to Sterility Concerns
KRS Global Biotechnology is recalling 1,815 syringes of a sterile ophthalmic topical solution because the company cannot assure the product's sterility.
Product
Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL) / Ketorolac Tromethamine 0.5% (2.5 mg/0.5 mL), Sterile Ophthalmic Topical Solution, 0.5 mL Fill in 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Bl
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0027-2020·2019-10-09
Colonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials for Sterility Concerns
Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because the product's sterility cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.
Product
C-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0101-2020·2019-10-09
Sodium Bicarbonate Syringes Recalled for Lack of Sterility Assurance
KRS Global Biotechnology is recalling 540 syringes of Sodium Bicarbonate 8.4% for IV use due to a lack of assurance of sterility.
Product
Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) (1 mEq/mL), 50 mL Fill in a 60 mL Single Dose Syringe, For IV Use, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674199
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0031-2020·2019-10-09
Colonia Care Pharmacy Recalls C-Phenol Injection Due to Sterility Concerns
Colonia Care Pharmacy is recalling C-Phenol/Cottonseed Oil Injection 5% vials because the sterility of the product cannot be guaranteed.
Product
C-PHENOL/COTTONSEED OIL INJ 5%, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0113-2020·2019-10-09
KRS Global Biotechnology Recalls Vitamin 9 Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 470 vials of Vitamin 9 Lyophilized for IM use nationwide because the product lacks assurance of sterility.
Product
Vitamin 9 Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674147
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0028-2020·2019-10-09
Colonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials Due to Sterility Concerns
Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because the product's sterility cannot be guaranteed.
Product
C-PAPAV/PHENTOL/PGE1 30MG/1MG/50MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0065-2020·2019-10-09
KRS Global Biotechnology Recalls Ketamine Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling 11,733 syringes of Ketamine in 0.9% Sodium Chloride due to a lack of assurance of sterility.
Product
Ketamine in 0.9% Sodium Chloride (PF) 50 mg/ 5mL (10 mg/mL) 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678093
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0023-2020·2019-10-09
Colonia Care Pharmacy Recalls C-Papav/Phentol/PGE1 Vials Due to Sterility Concerns
Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because the sterility of the product cannot be guaranteed. The recall affects patient-specific prescriptions in New Jersey.
Product
C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/11.8MCG/ML, 10 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0096-2020·2019-10-09
KRS Global Biotechnology Recalls Sermorelin Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling Sermorelin vials because the company cannot guarantee the product is sterile. Consumers should stop using the medication and contact their healthcare provider.
Product
Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673589
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0020-2020·2019-10-09
Colonia Care Pharmacy Recalls Sterility-Compromised C-Papav/Phentol/PGE1 Vials
Colonia Care Pharmacy is recalling specific vials of C-Papav/Phentol/PGE1 because sterility cannot be guaranteed. The product was distributed via patient-specific prescriptions in New Jersey.
Product
C-PAPAV/PHENTOL/PGE1 10MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0009-2020·2019-10-09
Colonia Care Pharmacy Recalls Dexamethasone Injection Due to Sterility Concerns
Colonia Care Pharmacy is recalling 37 vials of C-Dexamethasone 24mg/mL injection solution because the sterility of the product cannot be guaranteed.
Product
C-DEXAMETHASONE 24MG/ML INJ SOLUTION, packaged in 1 mL single dose vials, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0117-2020·2019-10-09
KRS Global Biotechnology Recalls L-Asparaginase Lyophilized Due to Sterility Concerns
KRS Global Biotechnology is recalling L-Asparaginase Lyophilized because the agency cannot assure the product's sterility. The recall covers all lots remaining within their expiration dates.
Product
L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674499
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0104-2020·2019-10-09
FDA Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling 1,350 syringes of Succinylcholine Chloride (PF) because the company cannot ensure the product is sterile.
Product
SUCCinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678417
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0060-2020·2019-10-09
FDA Recalls Hyaluronidase Ophthalmic Injection Due to Sterility Concerns
KRS Global Biotechnology is recalling 928 vials of Hyaluronidase Ophthalmic Injection because the product lacks assurance of sterility.
Product
Hyaluronidase (PF) Ophthalmic Injection 450 Units/3 mL (150 Units/mL) 3 mL Fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678359
Category
Drug
Distribution
Distributed nationwide

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1851–1875 of 8589