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

7026–7050 of 8593

SevereFDA (Drugs)·D-1201-2014·2014-04-16
Terra-Medica Recalls Pleo Quent Capsules Due to Penicillin Cross Contamination
Terra-Medica Inc. is recalling Pleo Quent capsules due to penicillin cross-contamination. The product was distributed in the US, Canada, and the Philippines.
Product
Pleo Quent CAPSULES 4X, 20 Capsule Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG NDC: 49807-2902-1.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1214-2014·2014-04-16
Zions RX Formulations Recalls Magnesium Sulfate Bags Due to Sterility Concerns
Zions RX Formulations is recalling 861 bags of Magnesium Sulfate in Lactated Ringers due to poor aseptic practices that compromise sterility assurance.
Product
Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1197-2014·2014-04-16
Terra-Medica Recalls Pleo Not Portable Sips Due to Penicillin Contamination
Terra-Medica Inc. is recalling specific batches of Pleo Not Portable Sips oral homeopathic medicine because of penicillin cross-contamination.
Product
Pleo Not PORTABLE SIPS, 6X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2308-1. Pleo Not PORTABLE SIPS, 6X, 50 x 1mL Ca
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1210-2014·2014-04-16
Terra-Medica Recalls Pleo Ex Drops Due to Penicillin Cross Contamination
Terra-Medica Inc. is recalling Pleo Ex DROPS 5X homeopathic antifungal medicine due to penicillin cross-contamination. The product was distributed in the US, Canada, the Philippines, and online.
Product
Pleo Ex DROPS 5X, 10 ml bottles, Homeopathic Antifungal Medicine, OTC Only. Made in Germany for: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GMbH & Co. KG. NDC: 49807-1003-1.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1208-2014·2014-04-16
Terra-Medica Recalls Pleo Fort Tablets Due to Penicillin Cross Contamination
Terra-Medica Inc. is recalling Pleo Fort Tablets 5X due to penicillin cross-contamination. The product was distributed nationwide and internationally.
Product
Pleo Fort TABLETS 5X, 20 Tablet Carton, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1102-1.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1218-2014·2014-04-16
Zions RX Formulations Recalls Bupivacaine Due to Sterility Concerns
Zions RX Formulations is recalling 60 units of Bupivacaine 3% in Arizona due to poor aseptic practices that compromised sterility assurance.
Product
Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1219-2014·2014-04-16
Zions RX Formulations Recalls Vitamin B-12 Injections Due to Sterility Concerns
Zions RX Formulations Services LLC is recalling specific lots of Vitamin B-12 injections due to a lack of assurance of sterility resulting from poor aseptic practices.
Product
Vitamin B-12 injections, a) 1 mL and b) 30 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1195-2014·2014-04-16
Terra-Medica Recalls Pleo Not DROPS Due to Penicillin Cross Contamination
Terra-Medica Inc. is recalling specific batches of Pleo Not DROPS homeopathic medicine due to penicillin cross contamination. The product was distributed in the US, Canada, and the Philippines.
Product
Pleo Not DROPS, 5X, 10 mL Bottles, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2301-1.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1192-2014·2014-04-16
Terra-Medica Recalls Pleo Not Suppositories Due to Penicillin Cross Contamination
Terra-Medica Inc. is recalling Pleo Not Suppositories 3X due to penicillin cross-contamination. The affected homeopathic medicine was distributed in the US, Canada, and the Philippines.
Product
Pleo Not SUPPOSITORIES 3X, 10 Suppository Cartons, Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2304-1.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1194-2014·2014-04-16
Terra-Medica Recalls Pleo Not Tablets Due to Penicillin Cross Contamination
Terra-Medica Inc. is recalling Pleo Not Tablets 5X because of penicillin cross contamination. The affected homeopathic medicine was distributed in the US, Canada, and the Philippines.
Product
Pleo Not TABLETS 5X, 20 Tablet Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2302-1.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1207-2014·2014-04-16
Terra-Medica Recalls Pleo-Fort Drops Due to Penicillin Cross-Contamination
Terra-Medica Inc. is recalling Pleo-Fort DROPS 5X homeopathic medicine due to penicillin cross-contamination. The product was distributed in the US, Canada, and the Philippines.
Product
Pleo-Fort DROPS 5X, 10ml bottle, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1101-1.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1200-2014·2014-04-16
Terra-Medica Recalls Pleo Quent Suppositories Due to Penicillin Contamination
Terra-Medica Inc. is recalling Pleo Quent Suppositories 3X due to penicillin cross-contamination. The product was distributed in the US, Canada, and the Philippines.
Product
Pleo Quent SUPPOSITORIES 3X, 10 Suppository Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2904-1.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1203-2014·2014-04-16
Terra-Medica Recalls Pleo Quent Homeopathic Medicine Due to Penicillin Contamination
Terra-Medica Inc. is recalling Pleo Quent homeopathic medicine because of penicillin cross-contamination. The product was distributed in the US, Canada, and the Philippines.
Product
Pleo Quent PORTABLE SIPS 5X, 10 x 1 ml Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2905-1. Pleo Quent PORTABLE SIPS 5X, 50 x 1 ml Cartons, Oral Homeopathic
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1204-2014·2014-04-16
Terra-Medica Recalls Pleo Fort Suppositories Due to Penicillin Cross Contamination
Terra-Medica Inc. is recalling Pleo Fort Suppositories because of penicillin cross-contamination. The product was distributed in the US, Canada, and the Philippines.
Product
Pleo Fort SUPPOSITORIES 3X, 10 Suppository Carton, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1106-1.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1217-2014·2014-04-16
Zions RX Formulations Recalls Sodium Bicarbonate Injectable Units
Zions RX Formulations is recalling 610 units of Sodium Bicarbonate 8.4% injectable products due to a lack of assurance of sterility.
Product
Sodium Bicarbonate 8.4%, a) 10 mL, b) 20 mL, and c) 22 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1215-2014·2014-04-16
Zions RX Formulations Recalls Potassium Phosphates Vials Due to Sterility Concerns
Zions RX Formulations is recalling 95 vials of Potassium Phosphates due to a lack of assurance of sterility caused by poor aseptic practices.
Product
Potassium Phosphates 4.4mEq/3mM/mL Vials, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1216-2014·2014-04-16
Zions RX Formulations Recalls Oxytocin Bags Due to Sterility Concerns
Zions RX Formulations is recalling 1,495 bags of Oxytocin 30 Units in 500mL Sodium Chloride 0.9% due to a lack of assurance of sterility.
Product
Oxytocin 30 Units in 500mL Sodium Chloride 0.9% Bags, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1212-2014·2014-04-16
Terra-Medica Recalls Pleo Stolo Drops Due to Penicillin Cross Contamination
Terra-Medica Inc. is recalling specific batches of Pleo Stolo DROPS 6X homeopathic medicine due to penicillin cross-contamination. Consumers should stop using the product and contact the company for a refund.
Product
Pleo Stolo DROPS 6X, 10ml Bottle; Homeopathic Anti-Inflammatory Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-0011-1.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1211-2014·2014-04-16
Terra-Medica Recalls Pleo Ex Portable Sips Due to Penicillin Contamination
Terra-Medica Inc. is recalling specific batches of Pleo Ex Portable Sips homeopathic medicine due to penicillin cross-contamination.
Product
Pleo Ex PORTABLE SIPS 5X, 10 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, NDC: 49807-1005-1. PLEO--EX Portable Sips 5X, 50 x 1 mL, Oral Hom
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1224-2014·2014-04-16
FDA Recalls Black Ant Supplement Containing Undeclared Sildenafil
The FDA is recalling Black Ant dietary supplements because laboratory analysis found they contain undeclared sildenafil, an FDA-approved drug for erectile dysfunction.
Product
Black Ant, 4600 mg x 4. Product is packaged in a small green box with gold lettering on the front, the back side of the box contains mostly foreign character. Within the box there are four (4) capsules individually wrapped in black and red plastic with white lettering. UPC 402
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1189-2014·2014-04-09
FDA Recalls HydrOXYzine HCl Tablets Due to Unapproved Ingredient Source
American Health Packaging is recalling HydrOXYzine HCl 50 mg tablets because the active ingredient came from an unapproved source.
Product
HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1163-2014·2014-03-26
Baxter Recalls Sodium Chloride IV Solutions Due to Particulate Matter
Baxter Healthcare is voluntarily recalling 0.9% Sodium Chloride Injection IV solutions due to the presence of particulate matter, including fibers and plastic particles.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1169-2014·2014-03-26
Clalis capsules recalled for undeclared sildenafil ingredient
Fabscout Entertainment, Inc. is recalling Clalis capsules because FDA analysis found they contain sildenafil, an undeclared active pharmaceutical ingredient.
Product
Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1170-2014·2014-03-26
Silver Sword capsules recalled for undeclared sildenafil ingredient
Fabscout Entertainment is recalling Silver Sword capsules because FDA analysis found they contain sildenafil, an undeclared active pharmaceutical ingredient.
Product
Silver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 970128 12345 (labeling is in foreign language)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1158-2014·2014-03-26
Baxter Recalls Clinimix E Bags Due to Particulate Matter
Baxter Healthcare is recalling 14,574 bags of Clinimix E IV solution found to contain particulate matter, including wood, sodium citrate, and dextrose.
Product
CLINIMIX E — CLINIMIX E (LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE)
Category
Drug
Distribution
Distributed nationwide

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