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

6851–6875 of 11856

SevereFDA (Drugs)·D-0664-2017·2017-04-19
Medisca Recalls Estrone USP Bulk Due to cGMP Deviations
Medisca, Inc. is recalling Estrone, USP Bulk in various bottle sizes due to current Good Manufacturing Practice (cGMP) deviations identified during an FDA inspection.
Product
ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5 grams (NDC 38779-0891-03), d) 25 grams (NDC 38779-0891-04), and e) 100 grams (NDC 38779-0891-09) Bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0891
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0659-2017·2017-04-19
FDA Recalls Ethinyl Estradiol Bulk Drug Due to Quality Assurance Failures
The FDA is recalling bulk Ethinyl Estradiol Micronized manufactured by Qinhuangdao Zizhu Pharmaceutical due to cGMP deviations and lack of quality assurance.
Product
Ethinyl Estradiol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China (NDC 44132-002-05)
Category
Drug
Distribution
6 states
SevereFDA (Drugs)·D-0657-2017·2017-04-19
FDA Recalls Estrone Micronized Bulk Drug Due to Quality Assurance Failures
The FDA is recalling Estrone Micronized bulk drug products manufactured by Qinhuangdao Zizhu Pharmaceutical due to cGMP deviations and lack of quality assurance.
Product
Estrone Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-003-04) (NDC 44132-003-02)(NDC 44132-003-06)
Category
Drug
Distribution
6 states
SevereFDA (Drugs)·D-0661-2017·2017-04-19
Akorn Recalls Latanoprost Ophthalmic Solution Due to Sterility Assurance Issues
Akorn, Inc. is recalling Latanoprost Ophthalmic Solution, 0.005%, because bottles were found empty, under-filled, or leaking, compromising sterility.
Product
LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-625-12
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0642-2017·2017-04-12
SCA Pharmaceuticals Recalls Vancomycin IV Bags Due to Particulate Matter
SCA Pharmaceuticals is recalling 490 bags of Vancomycin HCl IV solution due to the presence of particulate matter, linked to a related Hospira recall.
Product
Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0924-59
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0640-2017·2017-04-12
SCA Pharmaceuticals Recalls Vancomycin IV Bags Due to Particulate Matter
SCA Pharmaceuticals is recalling specific lots of Vancomycin HCl IV bags due to the presence of particulate matter, following a related Hospira recall.
Product
Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0920-59
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0637-2017·2017-04-12
X-Gen Recalls Ibuprofen Lysine Injection Due to Particulate Matter
X-Gen Pharmaceuticals is recalling 2,593 cartons of Ibuprofen Lysine Injection because of the presence of particulate matter. The affected product was distributed nationwide in the USA.
Product
IBUPROFEN LYSINE — IBUPROFEN LYSINE (IBUPROFEN LYSINE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0644-2017·2017-04-12
SCA Pharmaceuticals Recalls Vancomycin IV Bags Due to Particulate Matter
SCA Pharmaceuticals is recalling Vancomycin HCl IV bags due to the presence of particulate matter, linked to a related Hospira recall.
Product
Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0929-40
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0646-2017·2017-04-12
FDA Recalls XtraHRD Male Enhancement Capsules for Unapproved Drug Ingredient
Organic Herbal Supply is recalling XtraHRD Natural Male Enhancement Capsules because they contain N-desmethyl tadalafil, an unapproved drug ingredient.
Product
XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg capsules, 2, 4 and 10 count boxes, Made in Malaysia, Distributed by Naturally Hard Supplements, Reno, NV 89503, UPC 680474228768
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0641-2017·2017-04-12
SCA Pharmaceuticals Recalls Vancomycin IV Bags Due to Particulate Matter
SCA Pharmaceuticals is recalling 716 bags of Vancomycin HCl IV solution due to the presence of particulate matter.
Product
Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0923-59
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0625-2017·2017-04-12
Shire Recalls Kalbitor Due to Presence of Glass Particulate Matter
Shire is recalling specific lots of Kalbitor (ecallantide) injection because glass particles were found in the product.
Product
KALBITOR — KALBITOR (ECALLANTIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0645-2017·2017-04-12
SCA Pharmaceuticals Recalls Vancomycin HCl IV Bags Due to Particulate Matter
SCA Pharmaceuticals is recalling 62 bags of Vancomycin HCl 750 mg IV bags due to the presence of particulate matter.
Product
Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0918-40
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0648-2017·2017-04-12
Genentech Recalls Cotellic Tablets Due to Oversized Tablet Discovery
Genentech is recalling 748 bottles of Cotellic (cobimetinib) tablets because an oversized tablet was found in a bottle. The affected product was distributed in New Jersey and Illinois.
Product
COTELLIC — COTELLIC (COBIMETINIB)
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0639-2017·2017-04-12
SCA Pharmaceuticals Recalls Vancomycin IV Bags Due to Particulate Matter
SCA Pharmaceuticals is recalling 50 bags of Vancomycin HCl 1.25 g in 5% Dextrose 250 mL due to the presence of particulate matter.
Product
Vancomycin HCl 1.25 g added to 5% Dextrose 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0922-40
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0643-2017·2017-04-12
SCA Pharmaceuticals Recalls Vancomycin HCl IV Bags Due to Particulate Matter
SCA Pharmaceuticals is recalling 50 bags of Vancomycin HCl 1.5 gram IV bags due to the presence of particulate matter.
Product
Vancomycin HCl 1.5 gram added to 5% Dextrose 500 mL Total Approximate Volume 515 mL For IV Use Only, Rx Only , SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0925-44
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0638-2017·2017-04-12
Hospira Recalls Vancomycin Hydrochloride Injection Due to Particulate Matter
Hospira is recalling 30,880 vials of Vancomycin Hydrochloride for Injection because a hair was found inside a vial and contacted the drug.
Product
Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in 100 mL glass vial, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6510-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0622-2017·2017-04-05
Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination
Mylan Institutional, Inc. is recalling 1,527 cartons of Atorvastatin Calcium 10 mg tablets due to potential microbial contamination and elevated bioburden.
Product
ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0618-2017·2017-04-05
Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination
Mylan Pharmaceuticals is recalling specific lots of Atorvastatin Calcium 10 mg tablets due to potential microbial contamination and elevated bioburden.
Product
Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-3950-09); c) 500-count bottles (NDC 0378-3950-05); d) 500-count bottles (NDC 0378-3950-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0613-2017·2017-04-05
Claris Ciprofloxacin Injection Recalled for Potential Sterility Breach
Claris Lifesciences Inc. is recalling Ciprofloxacin in Dextrose Injection due to a potential leak that may compromise sterility.
Product
Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-009-24
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0614-2017·2017-04-05
Claris Fluconazole Injection Recalled for Potential Sterility Breach
Claris Lifesciences is recalling Fluconazole Injection due to a potential leak that could compromise sterility and contaminate the product.
Product
Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-003-06
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0615-2017·2017-04-05
Claris Lifesciences Recalls Levofloxacin Injection Due to Sterility Concerns
Claris Lifesciences Inc. is recalling Levofloxacin Injection due to a potential leak that may compromise sterility. The recall covers 24,456 units distributed nationwide.
Product
LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0616-2017·2017-04-05
Claris Recalls Metronidazole Injection Due to Sterility Concerns
Claris Lifesciences Inc. is recalling 72,072 units of Metronidazole Injection, USP, 500 mg/100 mL, due to a potential leak that may compromise sterility.
Product
Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-001-24
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0621-2017·2017-04-05
Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination
Mylan Pharmaceuticals is recalling Atorvastatin Calcium Tablets, 80 mg, due to potential microbial contamination and elevated bioburden.
Product
Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0619-2017·2017-04-05
Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination
Mylan Pharmaceuticals is recalling Atorvastatin Calcium Tablets 20 mg due to potential microbial contamination and elevated bioburden.
Product
Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0378-3951-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0620-2017·2017-04-05
Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination
Mylan Pharmaceuticals is recalling specific lots of Atorvastatin Calcium 40 mg tablets due to potential microbial contamination and elevated bioburden.
Product
Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b) 500-count bottles (NDC 0378-3952-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Category
Drug
Distribution
Distributed nationwide

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6851–6875 of 11856