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

4376–4400 of 11852

CriticalFDA (Drugs)·D-0320-2020·2019-11-06
Mero Macho Liquid Supplement Recalled for Tadalafil Contamination
Fitoterapia USA Inc. is recalling Mero Macho Passion Fruit Vitamin C Liquid Supplement because it was marketed without an approved NDA/ANDA and found to be tainted with Tadalafil.
Product
Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2.04 fl oz (60 mL) bottle, Manufactured By: Zaphiredelcor Cia, LTDA. Pasaje Luis Tola 9A Y Calle Juan Campuzano, Sector Carcelen, Quito-Ecuador 170302 Distributed By: Fitoterapia USA Inc., 500 NW 141 Ave.
Category
Drug
Distribution
3 states
SevereFDA (Drugs)·D-0160-2020·2019-11-06
Innoveix Recalls Lyophilized Human Chorionic Gonadotropin Due to Sterility Concerns
Innoveix Pharmaceuticals is recalling 290 vials of Lyophilized Human Chorionic Gonadotropin 5,500 USP Units due to a lack of sterility assurance.
Product
Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0164-2020·2019-11-06
AvKare Recalls Ranitidine Capsules Due to NDMA Impurity
AvKare is recalling Ranitidine Hydrochloride Capsules 150 mg because N-nitrosodimethylamine (NDMA) was found in the active ingredient.
Product
AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0158-2020·2019-11-06
Innoveix Recalls Lyophilized Human Chorionic Gonadotropin Due to Sterility Concerns
Innoveix Pharmaceuticals is recalling 413 vials of Lyophilized Human Chorionic Gonadotropin 5,000 USP Units due to a lack of sterility assurance.
Product
Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0165-2020·2019-11-06
AVKARE Recalls Ranitidine Hydrochloride Capsules Due to NDMA Impurity
AVKARE Inc. is recalling Ranitidine Hydrochloride Capsules 300 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA). The affected bottles were distributed in Colorado and Missouri.
Product
AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0157-2020·2019-11-06
Innoveix Recalls Lyophilized Chorionic Gonadotropin Due to Sterility Concerns
Innoveix Pharmaceuticals is recalling 3,905 vials of Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection due to a lack of sterility assurance.
Product
Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0159-2020·2019-11-06
Innoveix Recalls Lyophilized Sermorelin Injection Due to Sterility Concerns
Innoveix Pharmaceuticals is recalling 1,747 vials of compounded Sermorelin injection because the product lacks sterility assurance.
Product
Lyophilized Sermorelin w/ GHRP2 3 mg For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
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-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-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-0152-2020·2019-10-30
Avella Recalls Povidone Iodine Ophthalmic Solution Due to Sterility Concerns
Avella of Deer Valley, Inc. is recalling 808 droptainers of Povidone Iodine, 5% Ophthalmic Solution due to a lack of sterility assurance.
Product
Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharmacy, 24416 N. 19th Ave., Phoenix, AZ 85085. NDC 42852-006-20
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
HighFDA (Drugs)·D-0141-2020·2019-10-23
Spectrum Chemical Recalls Fentanyl Citrate Due to Glass Contamination
Spectrum Laboratory Products is recalling Fentanyl Citrate USP active pharmaceutical ingredient due to potential glass contamination. The product was distributed to compounding pharmacies and labs in four states.
Product
Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0140-2020·2019-10-23
Macleods Pharma Recalls Pioglitazone Tablets Due to Superpotent Content
Macleods Pharma USA is recalling 31,968 bottles of Pioglitazone Hydrochloride 15 mg tablets because the product is superpotent.
Product
PIOGLITAZONE — PIOGLITAZONE (PIOGLITAZONE)
Category
Drug
Distribution
0 states
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-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-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-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-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-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-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

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4376–4400 of 11852