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

4426–4450 of 11819

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-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-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
HighFDA (Drugs)·D-0135-2020·2019-10-16
Epic Pharma Recalls Estradiol Tablets Due to Foreign Tablet Presence
Epic Pharma is recalling Estradiol 0.5 mg tablets because 1 mg tablets were found in the bottles. Patients should stop using the product and contact their healthcare provider.
Product
ESTRADIOL — ESTRADIOL (ESTRADIOL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0136-2020·2019-10-16
Pfizer Recalls LMD in Dextrose Bags Due to Sterility Concerns
Pfizer is recalling 17,832 bags of LMD in Dextrose Injection due to a potential leak that compromises sterility.
Product
LMD IN DEXTROSE — LMD IN DEXTROSE (DEXTRAN 40)
Category
Drug
Distribution
Distributed nationwide
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-0084-2020·2019-10-09
KRS Global Biotechnology Recalls Phenylephrine and Lidocaine Ophthalmic Injection
KRS Global Biotechnology is recalling 825 syringes of Phenylephrine and Lidocaine Ophthalmic Injection due to a lack of assurance of sterility.
Product
Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678441
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0054-2020·2019-10-09
KRS Global Biotechnology Recalls Glycopyrrolate Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling Glycopyrrolate single-dose syringes nationwide because the company cannot guarantee the product is sterile.
Product
GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321678316
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-0114-2020·2019-10-09
KRS Global Biotechnology Recalls Vitamin 9A/B Lyophilized Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 6,325 vials of Vitamin 9A/B Lyophilized for IM use due to a lack of assurance of sterility.
Product
Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678339
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0124-2020·2019-10-09
Torrent Pharma Recalls Losartan Potassium/Hydrochlorothiazide Tablets Due to Impurity
Torrent Pharma Inc. is recalling Losartan Potassium/Hydrochlorothiazide Tablets because FDA testing found an impurity above acceptable levels.
Product
Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-118-90
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0092-2020·2019-10-09
KRS Global Biotechnology Recalls Quadmix # 19 Due to Sterility Concerns
KRS Global Biotechnology is recalling 95 vials of Quadmix # 19 because the company cannot ensure the product is sterile.
Product
Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine Mesylate-15 mg / Atropine Sulfate Monohydrate-1.5 mg/vial), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678383
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0083-2020·2019-10-09
KRS Global Biotechnology Recalls Oxytocin IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling Oxytocin IV bags because the company cannot guarantee the product is sterile.
Product
OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units / mL) Single Dose IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676819
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0098-2020·2019-10-09
KRS Global Biotechnology Recalls Sermorelin Acetate Due to Sterility Concerns
KRS Global Biotechnology is recalling Sermorelin Acetate 3 mg vials because the company cannot ensure the product is sterile.
Product
Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321601122
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-0042-2020·2019-10-09
KRS Global Biotechnology Recalls Bacteriostatic Water for Injection Due to Sterility Concerns
KRS Global Biotechnology is recalling Bacteriostatic Water for Injection vials because the product lacks assurance of sterility.
Product
Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674177
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0082-2020·2019-10-09
KRS Global Biotechnology Recalls Norepinephrine IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling 2,760 bags of Norepinephrine in 5% Dextrose IV solution due to a lack of assurance of sterility.
Product
Norepinephrine added to 5% Dextrose (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678217
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0004-2020·2019-10-09
Colonia Care Pharmacy Recalls C-Albumin 5% Ophthalmic Solution
Colonia Care Pharmacy is recalling C-Albumin 5% Ophthalmic Solution due to a lack of assurance of sterility. The product was distributed via patient-specific prescriptions in New Jersey.
Product
C-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles, 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-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-0032-2020·2019-10-09
Colonia Care Pharmacy Recalls Tacrolimus Ophthalmic Suspension Due to Sterility Concerns
Colonia Care Pharmacy is recalling specific lots of C-Tacrolimus 0.03% ophthalmic suspension because the sterility of the product cannot be guaranteed.
Product
C-TACROLIMUS 0.03% OPHTHAL SUSPENSION, 5 mL droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0076-2020·2019-10-09
KRS Global Biotechnology Recalls Moxifloxacin Ophthalmic Injection Due to Sterility Concerns
KRS Global Biotechnology is recalling Moxifloxacin 0.1% ophthalmic injection syringes due to a lack of assurance of sterility. The recall covers 9,920 syringes distributed nationwide.
Product
Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.3 mg/0.3 mL, 0.3 mL Fill in a 1 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678320
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0109-2020·2019-10-09
KRS Global Biotechnology Recalls Ophthalmic Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling 465 syringes of a sterile ophthalmic solution because the company cannot guarantee 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), 0.5 mL Fill in a 3 mL Syringe, Sterile Ophthalmic Topical Solution, (Contains Sulfites), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487
Category
Drug
Distribution
Distributed nationwide

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4426–4450 of 11819