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

4101–4125 of 11819

SevereFDA (Drugs)·D-0565-2020·2019-12-11
QuVa Pharma Recalls Fentanyl and Bupivacaine Injection Due to Particulate Matter
QuVa Pharma is recalling specific lots of fentanyl and bupivacaine injection due to the presence of particulate matter, including potential glass particles.
Product
fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/mL) in 0.9% Sodium Chloride Preservative Free 100 mL in 150 mL Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1103-36
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0560-2020·2019-12-11
QuVa Pharma Recalls Fentanyl Syringes Due to Glass Particulate Matter
QuVa Pharma is recalling fentanyl 250 mcg/5 mL syringes due to the presence of glass particulate matter. The recall is nationwide.
Product
fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1098-44
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0550-2020·2019-12-11
QuVa Pharma Recalls Fentanyl and Bupivacaine Injection Due to Particulate Matter
QuVa Pharma is recalling fentanyl and bupivacaine injection bags due to the presence of particulate matter, specifically potential glass particles.
Product
fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride Preservative Free, 100 mL in 150 Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1104-36
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0566-2020·2019-12-11
QuVa Pharma Recalls Fentanyl Syringes Due to Glass Particulate Matter
QuVa Pharma is recalling specific lots of fentanyl syringes because they may contain glass particulate matter.
Product
fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1415-47
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0555-2020·2019-12-11
QuVa Pharma Recalls Fentanyl Infusions Due to Glass Particulate Matter
QuVa Pharma is recalling fentanyl 10 mcg/mL infusion bags nationwide due to the potential presence of glass particulate matter.
Product
fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1092-36
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0557-2020·2019-12-11
QuVa Pharma Recalls Fentanyl and Bupivacaine Injection Due to Particulate Matter
QuVa Pharma is recalling fentanyl and bupivacaine injection products due to the presence of particulate matter, specifically potential glass particles.
Product
fentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride, 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1202-75
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0533-2020·2019-12-11
Fagron Recalls LETS GEL Kits Due to Microbial Contamination
Fagron, Inc. is recalling 11,912 kits of LETS GEL Convenience Packs due to microbial contamination of the non-sterile product.
Product
LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4 g, Ephinephrine Bitartrate - 180 mg, Tetracaine Hydrochloride - 500 mg, Sodium Metabisulfite - 75 mg, SuturaGel Methlcellulose Base; RX Only, For Prescription
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0548-2020·2019-12-11
QuVa Pharma Recalls Fentanyl and Ropivacaine Infusions Due to Particulate Matter
QuVa Pharma is recalling specific lots of fentanyl and ropivacaine infusions due to the presence of particulate matter, including potential glass particles.
Product
fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride 100 mL CADD, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478NDC 70092-1259-75
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0553-2020·2019-12-11
QuVa Pharma Recalls Fentanyl Infusion Bags Due to Glass Particulates
QuVa Pharma is recalling fentanyl infusion bags because they may contain glass particulates. The affected product is distributed nationwide.
Product
fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1093-37
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0524-2020·2019-12-04
AVKARE Recalls Ranitidine Tablets Due to NDMA Impurity
AVKARE Inc. is recalling specific lots of Ranitidine Tablets 150 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).
Product
AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 a) 1000 tablets NDC 42291-724-10; b) 180 tablets NDC 42291-724-18; c) 60 tablets NDC 42291-724-60
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0531-2020·2019-12-04
Ibuprofen Oral Suspension Recalled for Inert Plastic Particles
Preferred Pharmaceuticals is recalling specific lots of Ibuprofen Oral Suspension USP due to the presence of small particles of inert plastic material.
Product
Ibuprofen Oral Suspension USP, 100 mg/5mL, 4 fl.oz. 118 mL, Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA. Mfg: Taro Pharm.; Hawthorne, NY; NDC 68788-7268-01
Category
Drug
Distribution
3 states
SevereFDA (Drugs)·D-0573-2020·2019-12-04
AuroMedics Recalls MARLIDO KIT Vials Due to Foreign Material Presence
AuroMedics Pharma LLC is recalling MARLIDO KIT vials because foreign material was found inside the vials. The affected product is Lidocaine HCl Injection, USP, 2%.
Product
MARLIDO KIT — MARLIDO KIT (MARCAINE, LIDOCAINE, POVIDONE IODINE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0526-2020·2019-12-04
AuroMedics Recalls Ranitidine Tablets Due to NDMA Detection
AuroMedics Pharma LLC is recalling DG Health Acid Reducer Ranitidine Tablets 150 mg because N-nitrosodimethylamine (NDMA) was detected in the product.
Product
DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0525-2020·2019-12-04
AVKARE Recalls Ranitidine Tablets Due to NDMA Impurity
AVKARE Inc. is recalling specific lots of Ranitidine Tablets 300 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).
Product
AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0530-2020·2019-12-04
Aurobindo Ranitidine Capsules Recalled for NDMA Contamination
AuroMedics Pharma LLC is recalling Aurobindo Ranitidine Capsules 150 mg because N-nitrosodimethylamine (NDMA) was detected in the product.
Product
Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-05
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0529-2020·2019-12-04
AuroMedics Recalls Ranitidine Syrup Due to NDMA Contamination
AuroMedics Pharma LLC is recalling Ranitidine Syrup because N-nitrosodimethylamine (NDMA) has been detected in the product.
Product
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0528-2020·2019-12-04
Aurobindo Ranitidine Capsules Recalled for NDMA Contamination
AuroMedics Pharma LLC is recalling Aurobindo Ranitidine Capsules 300 mg because N-nitrosodimethylamine (NDMA) was detected in the product.
Product
Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-145-30
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0523-2020·2019-12-04
New Vitalis Pharmacy Recalls Testosterone Injection Due to Sterility Concerns
New Vitalis Pharmacy is recalling Testosterone Cypionate and Propionate oil injection solutions due to a lack of sterility assurance.
Product
Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution, 10 mL per vial, New Vitalis Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0527-2020·2019-12-04
Aurobindo Ranitidine Capsules Recalled for NDMA Contamination
AuroMedics Pharma LLC is recalling Aurobindo Ranitidine Capsules 150 mg because N-nitrosodimethylamine (NDMA) was detected in the product.
Product
Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0370-2020·2019-11-27
Altaire Recalls Equate Eye Drops Due to Sterility Concerns
Altaire Pharmaceuticals is recalling Equate Support Advanced Lubricating Eye Drops because the company cannot guarantee the product is sterile.
Product
Equate Support Advanced Lubricating Eye Drops, Preservative Free, Sterile, 25 Single-Use Containers, 0.02 Fl. oz. (0.6 mL), W-M item #: 563031654, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-882-54
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0483-2020·2019-11-27
Altaire Recalls FreshKote Lubricant Eye Drops Due to Sterility Concerns
Altaire Pharmaceuticals is recalling FreshKote Lubricant Eye Drops because the company cannot ensure the product is sterile.
Product
FreshKote Lubricant Eye Drops, Product Size: 15 mL, NDC 15821-101-15
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0389-2020·2019-11-27
CVS Lubricant Eye Drops Recalled for Lack of Sterility Assurance
Altaire Pharmaceuticals is recalling CVS Health Preservative Free Lubricant Eye Drops due to a lack of assurance of sterility.
Product
CVS Health Preservative Free Lubricant Eye Drops (Carboxymethyl-Cellulose Sodium 0.5%, Sensitive Solution, 30 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #495301, NDC 50428 42216 8, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0423-2020·2019-11-27
Altaire Sterile Eye Wash Recalled for Lack of Sterility Assurance
Altaire Pharmaceuticals is recalling Altaire Sterile Eye Wash because the company cannot guarantee the product is sterile.
Product
Altaire Sterile Eye Wash, 15 mL (1/2 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-175-13
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0467-2020·2019-11-27
Altaire Recalls Natural Ophthalmics Eye Drops Due to Sterility Concerns
Altaire Pharmaceuticals is recalling Natural Ophthalmics Allergy Desensitization Eye Drops because the company cannot ensure the product is sterile.
Product
Natural Ophthalmics Allergy Desensitization Eye Drops, 15 mL, NDC 68770-120-15
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0441-2020·2019-11-27
Altaire Recalls Tetcaine Ophthalmic Solution Due to Sterility Concerns
Altaire Pharmaceuticals is recalling Tetcaine ophthalmic solution because the product may not be sterile. Patients should stop using the medication and consult a healthcare provider.
Product
Tetcaine (Tetracaine Hydrochloride) Ophthalmic Solution USP, 0. 5 fl oz (15 mL), Rx only, Manufactured for OCuSOFT, Inc. Rosenberg, TX 77471 USA, NDC 54799-502-15
Category
Drug
Distribution
Distributed nationwide

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4101–4125 of 11819