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

10551–10575 of 18028

SevereFDA (Drugs)·D-1054-2017·2017-08-09
Vi-Jon Recalls Magnesium Citrate Oral Solution Due to Mold Contamination
Vi-Jon, Inc. is recalling 101,244 bottles of Magnesium Citrate Oral Solution because the product was found to contain mold identified as Rhinocladiella similis.
Product
Magnesium Citrate Oral Solution, packaged in a 10 fl. oz. (296 mL) glass bottle, OTC, labeled as: a) GoodSense Magnesium Citrate Oral Solution Saline Laxative Very Low Sodium, UPC# 846036007381, NDC 50804-686-38, Distributed by: Geiss, Desitin &Dunn, Inc., Peachtree City, GA 3026
Category
Drug
Distribution
3 states
SevereFDA (Drugs)·D-1047-2017·2017-08-09
Hospira Recalls 8.4% Sodium Bicarbonate Injection Due to Sterility Concerns
Hospira is recalling 8.4% Sodium Bicarbonate Injection vials because they may lack sterility assurance. The recall covers 91,483,150 vials distributed in the U.S. and internationally.
Product
8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA, NDC: 0409-6625-02
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1049-2017·2017-08-09
Hospira Recalls Sodium Bicarbonate Additive Solution Due to Sterility Concerns
Hospira is recalling specific lots of Sodium Bicarbonate 4% Additive Solution because they may lack sterility assurance. The recall covers 21.4 million vials distributed in the U.S. and internationally.
Product
Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-25), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1046-2017·2017-08-09
Hospira Recalls Potassium Phosphates Injection Due to Sterility Concerns
Hospira is recalling 20.3 million vials of Potassium Phosphates Injection because of a lack of sterility assurance. The product was distributed in the U.S. and several international locations.
Product
Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution: Must Be Diluted, Rx Only, Mfd by Hospira, Inc. Lake Forest, IL 60045 USA, NDC: 0409-7295-01
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1052-2017·2017-08-09
VistaPharm Recalls Lactulose Solution Due to Microbial Contamination
VistaPharm is recalling Lactulose Solution, USP, because the product failed microbial testing for yeast and mold counts.
Product
Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-50
Category
Drug
Distribution
7 states
SevereFDA (Drugs)·D-1048-2017·2017-08-09
Hospira Recalls Quelicin Injection Due to Lack of Sterility Assurance
Hospira is recalling Quelicin (succinylcholine chloride) injection vials because they may lack sterility assurance. The recall covers 15,034,600 vials distributed in the U.S. and internationally.
Product
QUELICIN — QUELICIN (SUCCINYLCHOLINE CHLORIDE)
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1036-2017·2017-08-09
Cyclobenzaprine Tablets Recalled for Incorrect Amantadine Labeling
Apace KY LLC is recalling Cyclobenzaprine HCl 5 mg tablets because cartons were mislabeled as Amantadine HCl 100 mg capsules.
Product
Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, Rx Only, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0190-15
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-1040-2017·2017-08-09
Axia Pharmaceutical Recalls Compounded Testosterone Cypionate and Progesterone Vials
Axia Pharmaceutical is recalling 120 vials of compounded Testosterone Cypionate and Progesterone due to CGMP deviations. The product was distributed to one customer in California.
Product
Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical, Los Angeles, CA 90025
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-1056-2017·2017-08-09
Teva Recalls Famotidine Tablets Due to Weight Specification Failures
Teva Pharmaceuticals USA is recalling 28,188 bottles of Famotidine 20 mg tablets because they failed tablet weight specifications.
Product
FAMOTIDINE — FAMOTIDINE (FAMOTIDINE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1037-2017·2017-08-09
Precision Dose Recalls Carbamazepine Oral Suspension Due to Carton Labeling Error
Precision Dose Inc. is recalling Carbamazepine Oral Suspension because the product cartons list incorrect volume and NDC numbers, although the individual unit dose cups are correctly labeled.
Product
Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59.
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-1051-2017·2017-08-09
Bayer Recalls Alka-Seltzer Gold Tablets Due to Defective Blister Pack Foil
Bayer HealthCare is recalling Alka-Seltzer Gold effervescent tablets because customer complaints confirmed small holes or cracks in the foil of the blister packs.
Product
Alka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium bicarbonate, 1050 mg Antacid Sodium bicarbonate/Antacid) Effervescent Tablets, 36-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500041085
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1055-2017·2017-08-09
Time-Cap Recalls Ibuprofen Tablets Due to Foreign Capsule Presence
Time-Cap Laboratories is recalling 1,980 bottles of 600 mg ibuprofen tablets because some bottles contained 800 mg tablets.
Product
IBUPROFEN — IBUPROFEN (IBUPROFEN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1042-2017·2017-08-09
Zydus Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications
Zydus Pharmaceuticals is recalling Divalproex Sodium Delayed Release Tablets because they failed to meet dissolution specifications.
Product
Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 68382-032-05),Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1038-2017·2017-08-09
Dr. Reddy's Recalls Pravastatin Sodium Tablets Due to Impurity
Dr. Reddy's Laboratories is recalling specific lots of Pravastatin Sodium tablets because they failed impurity specifications.
Product
PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1053-2017·2017-08-09
VistaPharm Recalls Lactulose Solution Due to Microbial Contamination
VistaPharm is recalling Lactulose Solution, USP, because the product failed microbial testing for yeast and mold counts.
Product
Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-01
Category
Drug
Distribution
7 states
ModerateFDA (Drugs)·D-1035-2017·2017-08-09
Apace KY LLC Recalls Amantadine HCl Capsules Due to Labeling Error
Apace KY LLC is recalling 1,483 cartons of Amantadine HCl Capsules because they were mislabeled and contain Cyclobenzaprine HCl tablets instead.
Product
Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0069-15
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-1057-2017·2017-08-09
PD-Rx Pharmaceuticals Recalls Famotidine 20 mg Tablets for Weight Issues
PD-Rx Pharmaceuticals is recalling 100 bottles of Famotidine USP 20 mg tablets because they failed to meet tablet weight specifications.
Product
Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 --- NDC 55289-765-30
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1043-2017·2017-08-09
Zydus Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications
Zydus Pharmaceuticals is recalling Divalproex Sodium Delayed Release Tablets because they failed to meet dissolution specifications.
Product
Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1041-2017·2017-08-09
Zydus Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications
Zydus Pharmaceuticals is recalling Divalproex Sodium Delayed Release Tablets because they failed to meet dissolution specifications.
Product
Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054, NDC 68382-031-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1044-2017·2017-08-09
Bayer Recalls Alka-Seltzer Tablets Due to Defective Blister Pack Foil
Bayer HealthCare is recalling Alka-Seltzer Original effervescent tablets because customer complaints confirmed small holes or cracks in the foil of the blister packs.
Product
Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 12-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500040194
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1050-2017·2017-08-09
Bayer Recalls Alka-Seltzer Extra Strength Tablets Due to Defective Packaging
Bayer is recalling Alka-Seltzer Extra Strength effervescent tablets because customer complaints confirmed small holes or cracks in the foil blister packs.
Product
Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 24-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500044048
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1039-2017·2017-08-09
Teva Recalls Albuterol Sulfate Inhalation Solution Due to Impurities
Teva Pharmaceuticals USA is recalling Albuterol Sulfate Inhalation Solution because high levels of a related compound were detected.
Product
Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per carton, Rx only, Mfd. for: Watson Laboratories, Inc., Corona, CA 92880; Mfd. by: Cipla Ltd., Verna, Goa INDIA, NDC 0591-3467-53.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1033-2017·2017-08-02
SCA Pharmaceuticals Recalls Potassium Chloride Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling specific lots of Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL due to lack of assurance of sterility and potential for leaking.
Product
Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0833-40
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1017-2017·2017-08-02
SCA Pharmaceuticals Recalls Hydromorphone Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling specific lots of Hydromorphone injection syringes because they may leak and lack assurance of sterility.
Product
Hydromorphone 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Fill in 3 mL BD syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0302-05
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1011-2017·2017-08-02
SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Infusion Bags for Sterility Concerns
SCA Pharmaceuticals is recalling specific lots of fentanyl and bupivacaine infusion bags due to a lack of assurance of sterility and potential for leaking.
Product
fentaNYL 2 mcg/mL+Bupivacaine 0.0625% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0226-40
Category
Drug
Distribution
Distributed nationwide

How to read this listing

Filters

10551–10575 of 18028