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

10226–10250 of 17785

LowFDA (Drugs)·D-0073-2018·2017-11-01
Vi-Jon Recalls Equate and Studio 35 Face Moisturizers for Stability Failures
Vi-Jon, Inc. is recalling Equate and Studio 35 Clarifying Face Daily Moisturizers because the products failed stability specifications. The recall covers 67,532 bottles distributed nationwide.
Product
Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716, NDC # 4903594126 UPC # 681131150774. Studio 35 Beauty Daily Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distributed By: Walgreen Co. 200 Wilmo
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0052-2018·2017-11-01
Teva Recalls Methylphenidate Hydrochloride Tablets Due to Dissolution Failures
Teva Pharmaceuticals USA is recalling 58,292 bottles of Methylphenidate Hydrochloride Tablets USP, 20 mg, because they failed to meet dissolution specifications.
Product
Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0034-2018·2017-11-01
AbbVie Recalls AndroGel Testosterone Gel Due to Temperature Abuse
AbbVie is recalling 48 cartons of AndroGel testosterone gel distributed in Arizona due to prolonged exposure to temperatures outside labeled storage conditions.
Product
AndroGel (testosterone gel) 1.62%, 40.5mg in 2.5g aluminum foil packet, 30 Packets per carton. Rx Only. Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-30
Category
Drug
Distribution
1 state
LowFDA (Drugs)·D-0051-2018·2017-11-01
Wockhardt Recalls Enalapril Maleate Tablets Due to Impurity Failures
Wockhardt USA is recalling 5mg Enalapril Maleate tablets because they failed impurity specifications. The recall covers 5,050 bottles distributed nationwide.
Product
Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangabad, Maharashtra, India, Distributed by: Wockhardt, USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054, USA. NDC: 64679-924-03;
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0146-2018·2017-11-01
Taro Recalls Fluocinonide Gel Due to Dapsone Cross-Contamination
Taro Pharmaceuticals is recalling 16,944 tubes of Fluocinonide Gel USP 0.05% because traces of Dapsone were found in the finished product.
Product
FLUOCINONIDE — FLUOCINONIDE (FLUOCINONIDE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0033-2018·2017-11-01
AbbVie Recalls AndroGel Testosterone Gel Due to Temperature Abuse
AbbVie is recalling specific lots of AndroGel testosterone gel because prolonged exposure to temperatures outside labeled storage conditions may have affected the product.
Product
AndroGel (testosterone gel) 1.62%, 88 gm metered-dose pump, 20.25 mg of testosterone per pump actuation, 60 metered pump actuations, Rx Only, Marketed by: AbbVie Inc., North Chicago, IL 60064 USA. NDC: 0051-8462-33
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0013-2018·2017-10-25
Alprazolam Tablets Recalled for Unknown Impurity
The Harvard Drug Group is recalling Alprazolam Tablets, 0.25 mg, due to an out-of-specification result for an unknown impurity.
Product
Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; Distributed by: Major Pharmaceuticals, 17177 N. Laure
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0011-2018·2017-10-25
Symbio Muc Eye Recalled Due to Lack of Sterility Assurance
Deserving Health International Corp is recalling Symbio Muc Eye eye drops because the product lacks assurance of sterility. The affected units were distributed throughout the United States.
Product
Symbio Muc Eye, 0.17 fl.oz. 5mL bottles, Manufactured for and distributed in the US b: Biological Health Group Corp. Bremerton, WA 98337. NDC 69711-125-61
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0012-2018·2017-10-25
RXQ Compounding Recalls Methylprednisolone Acetate Injection Due to Sterility Concerns
RXQ Compounding LLC is recalling 945 vials of methylprednisolone acetate injection because autoclave parameters were incorrect, raising concerns about product sterility.
Product
methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10
Category
Drug
Distribution
6 states
ModerateFDA (Drugs)·D-0010-2018·2017-10-25
Unichem Recalls Bisoprolol Fumarate Tablets Due to Stability Impurity
Unichem Pharmaceuticals is recalling 96,876 bottles of Bisoprolol Fumarate 5 mg tablets because stability testing revealed an out-of-specification unknown impurity.
Product
BISOPROLOL FUMARATE — BISOPROLOL FUMARATE (BISOPROLOL FUMARATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0008-2018·2017-10-18
United Pharmacy Recalls Compounded Glutamine Injection Vials Due to CGMP Deviations
United Pharmacy is recalling 268 vials of compounded Glutamine, Arginine, and Carnitine injection due to CGMP deviations and the absence of glutamine.
Product
Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Compounded, 13951 N. Haverhill Rd Ste. 120-121 West Palm Beach, FL 33417
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0009-2018·2017-10-18
Dr. Reddy's Recalls Famotidine Tablets Due to Impurity Failure
Dr. Reddy's is recalling specific lots of famotidine tablets sold as CVS Pharmacy Acid Controller and Equate Famotidine due to an out-of-specification impurity result.
Product
FAMOTIDINE — FAMOTIDINE (FAMOTIDINE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0007-2018·2017-10-18
Mobic Tablets Recalled for Incorrect Package Insert Labeling
Boehringer Ingelheim is recalling 128 bottles of Mobic 15 mg tablets because they were packaged with an incorrect insert.
Product
Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Lic. from: BI Int'l GmbH, Made in Italy, NDC 0597-0030-01
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0002-2018·2017-10-11
Inopak Recalls Antibacterial Hand Wash Due to Potential Bacterial Contamination
Inopak Ltd is recalling Option Systems and STYLE Antibacterial Hand Wash due to GMP deviations and potential bacterial contamination from a pump.
Product
Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and 500, mL 800 mL, and 1000 mL pouches, ALSO labeled as STYLE Antibacterial Hand Soap, Inopak Ltd Ringwood, NJ --- NDC 5031-431-02
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0004-2018·2017-10-11
Inopak Choice Antibacterial Hand Soap Recalled for Potential Bacterial Contamination
Inopak Ltd is recalling Choice Antibacterial Hand Soap due to GMP deviations and potential bacterial contamination from a pump.
Product
Choice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Universal Valve, Inopak LTD, Ringwood, NJ
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0005-2018·2017-10-11
Vi-Jon Recalls Magnesium Citrate Oral Solution for Impurity Failures
Vi-Jon, Inc. is recalling 348,384 bottles of Magnesium Citrate Oral Solution because the product failed impurities and degradation specifications.
Product
Magnesium Citrate Oral Solution Lemon Flavor, 1.745g per fl oz, packaged in 10 fl. oz. (296 mL) bottles, Labeled as a) CVS Health, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; NDC 59779-667-38, UPC 05042842790; b) Swan Citroma, Distributed by: Vi-Jon O
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0003-2018·2017-10-11
Inopak Recalls Mild Healthcare Antibacterial Hand Soap Due to Contamination Risk
Inopak Ltd is recalling specific batches of Mild Healthcare Antibacterial Hand Soap due to potential bacterial contamination from a defective pump.
Product
Mild Healthcare Antibacterial Hand Soap, 6% P.C.M.X., 1000 mL and 2000 mL Disc Pump, 800 mL Universal Valve, and 1 gallon bottles, Inopak. Ltd, Ringwood, NJ 07456
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0006-2018·2017-10-11
Vi-Jon Recalls Magnesium Citrate Oral Solution for Impurity Failures
Vi-Jon, Inc. is recalling 87,972 bottles of Magnesium Citrate Oral Solution because the product failed impurities and degradation specifications.
Product
Magnesium Citrate Oral Solution Cherry Flavor, 1.745 g per fl oz, packaged in 10 fl. oz ( 296 mL) bottles, Labeled as a) CVS Health, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; NDC 6984238038, UPC 050428418321, b) Meijer, Dist. By Meijer Distribution,
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-0001-2018·2017-10-11
Pfizer Recalls Deferoxamine Mesylate Injection Due to CGMP Deviations
Pfizer is recalling 32,276 vials of Deferoxamine Mesylate for injection due to a failure to control impurities causing color change at the API stage.
Product
Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial. Intravenous, Intramuscular, Subcutaneous Use, Rx Only, Hospira, Inc., Lake Forest IL USA, NDC 0406-2336-10.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1177-2017·2017-10-04
Pfizer Recalls Sterile Water for Injection Vials Due to Cracked Glass
Pfizer is recalling 18,725 vials of Sterile Water for Injection due to cracked or chipped glass at the neck, which poses a non-sterility risk.
Product
Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA for Genentech, Inc., South San Francisco, CA 94080-4990. NDC 50242-901-24
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1178-2017·2017-10-04
Teva Recalls Acarbose Tablets Due to Incorrect Expiration Date Labeling
Teva Pharmaceuticals USA is recalling 3,275 bottles of Acarbose Tablets, 25 mg, because the product labeling displays an incorrect expiration date of July 2018 instead of the correct date of July 2017.
Product
Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 16252-523-01.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1176-2017·2017-10-04
Ketorolac Injection Recalled for Visible Crystalline Particulate
RemedyRepack Inc. is recalling 40 vials of Ketorolac Trom 30 mg/mL Injection due to visible crystalline particulate.
Product
Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials, NDC 61786-0741-01 (Orig: 00548-9021-00), Ref: 33631 and b) 10 x 1 mL vials per tray, NDC 61786-0741-08 (Orig: 00548-9021-00), Ref: 33632, Rx only, Packaged by: RemedyRepack Inc, Indiana, PA 15704; Mfg by: Amphastar, Ra
Category
Drug
Distribution
1 state
LowFDA (Drugs)·D-1179-2017·2017-10-04
Sandoz Recalls Ampicillin Vials Due to Missing Labels
Sandoz Inc is recalling 13,435 packs of Ampicillin for Injection because some vials are missing labels. The recall covers distribution in the USA and Puerto Rico.
Product
AMPICILLIN — AMPICILLIN (AMPICILLIN SODIUM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1175-2017·2017-09-27
Genentech Recalls Activase Due to Cracked Sterile Water Vials
Genentech is recalling 16,882 units of Activase (alteplase) because the included sterile water vials may have cracked or chipped glass.
Product
Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-dose 100ml vial of sterile water for Injection USP and one transfer device. Manufactured by: Genentech, Inc. 1 DNA Way, South San Francisco, CA 84080-4990. NDC: 50242-0085-27
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1167-2017·2017-09-27
Pfizer Recalls Hydromorphone Hydrochloride Injection Due to Sterility Assurance Concerns
Pfizer is recalling 115,370 vials of Hydromorphone Hydrochloride Injection because a damaged sterilizing filter may have compromised sterility assurance during manufacturing.
Product
HYDROMORPHONE HYDROCHLORIDE — HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide

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10226–10250 of 17785