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

9576–9600 of 18028

SevereFDA (Drugs)·D-0910-2018·2018-07-11
Fagron Recalls Neostigmine Methylsulfate Syringes Due to Labeling Error
Fagron Sterile Services is recalling 840 prefilled syringes of Neostigmine Methylsulfate Injection Solution because they may be incorrectly labeled with the wrong strength.
Product
Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-02.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0905-2018·2018-07-11
SCA Pharmaceuticals Recalls Phenylephrine Bags Due to Leakage Risk
SCA Pharmaceuticals is voluntarily recalling 196 bags of Phenylephrine HCL 80mg in 0.9% Sodium Chloride due to a potential for leakage that compromises sterility.
Product
Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0901-2018·2018-07-11
SCA Pharmaceuticals Recalls Phenylephrine HCL Bags Due to Leakage Risk
SCA Pharmaceuticals is voluntarily recalling 451 bags of Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL due to a potential for leakage that compromises sterility.
Product
Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0896-2018·2018-07-11
SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Bags Due to Leakage Risk
SCA Pharmaceuticals is voluntarily recalling specific lots of sterile fentanyl and bupivacaine admixture bags due to a potential for leakage that compromises sterility.
Product
Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0904-2018·2018-07-11
SCA Pharmaceuticals Recalls Phenylephrine HCL Bags Due to Leakage Risk
SCA Pharmaceuticals is voluntarily recalling specific lots of Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL bags due to a potential for leakage that compromises sterility.
Product
Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0900-2018·2018-07-11
SCA Pharmaceuticals Recalls Norepinephrine Bags Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling specific lots of Norepinephrine Bitartrate bags due to a potential for leakage that compromises sterility.
Product
Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0899-2018·2018-07-11
SCA Pharmaceuticals Recalls Norepinephrine Bitartrate Bags Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling specific lots of Norepinephrine Bitartrate 8 mg bags due to a potential for leakage that compromises sterility.
Product
Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0908-2018·2018-07-11
Eb5 Age Spot Treatment Cream Recalled for Stability Failures
Eb5 Corporation is recalling 4,632 tubes of Age Spot Treatment Cream because the product failed stability specifications for viscosity, pH, and specific gravity.
Product
eb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hydroquinone. 177.4 ml / 6 fl oz carton containing a tube. Manufactured For: EB5 Corporation Portland, OR 97210 Carton Bar Code: 7 41099 00009 9
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-0907-2018·2018-07-11
Equate ClearLAX Recalled for Unfiled NDC Numbers on Labeling
Lupin Somerset is recalling Equate ClearLAX laxative bottles due to unfiled NDC numbers on the labels. This is a Class III recall with no reported health risks.
Product
Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (NDC 49035-312-07), b) 238 g bottle (NDC 49035-312-08), Distributed by: Wal-mart Stores, Inc., Bentonville, AR 72716
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0893-2018·2018-07-11
Qualgen Recalls Testosterone Pellets Due to Incorrect Lot and Expiration Dates
Qualgen, LLC is recalling Testosterone 200 mg Pellets because the vials have incorrect or missing lot and expiration dates.
Product
TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-120-01
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0892-2018·2018-07-11
Qualgen Recalls Estradiol Pellets Due to Incorrect or Missing Lot and Expiration Dates
Qualgen, LLC is recalling Estradiol 20mg Pellets because the vials have incorrect or missing lot and expiration dates.
Product
ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01
Category
Drug
Distribution
Distributed nationwide
HighCPSC·18183·2018-07-06
Sandoz and Novartis Recall Prescription Blister Packages for Child-Resistant Failure
Sandoz and Novartis are recalling about 470,000 blister packages of prescription drugs because the packaging failed to meet child-resistant closure requirements, posing a poisoning risk to children.
Product
Blister packages of prescription medication
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0889-2018·2018-07-04
Advanced Pharma Recalls Subpotent Fentanyl Citrate Prefilled Syringes
Advanced Pharma Inc. is recalling 100 prefilled syringes of fentanyl citrate because the final drug concentration is subpotent compared to the label.
Product
fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0881-2018·2018-06-27
ICU Medical Recalls 0.45% Sodium Chloride Injection Bags Due to Sterility Concerns
ICU Medical Inc. is recalling 88,960 bags of 0.45% Sodium Chloride Injection due to a lack of assurance of sterility and potential for leaking.
Product
0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0882-2018·2018-06-27
ICU Medical Recalls Sodium Chloride Injection Bags Due to Sterility Concerns
ICU Medical is recalling 941,496 bags of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility and potential for leaking.
Product
0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0883-2018·2018-06-27
ICU Medical Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns
ICU Medical is recalling 525,984 bags of 0.9% Sodium Chloride Injection due to potential leaks that compromise sterility. The product was distributed nationwide and in Canada.
Product
0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0885-2018·2018-06-27
ICU Medical Recalls 5% Dextrose Injection Bags Due to Sterility Concerns
ICU Medical is recalling 5% Dextrose Injection bags because they may leak, compromising sterility. The recall covers 267,288 bags distributed nationwide and in Canada.
Product
5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0884-2018·2018-06-27
ICU Medical Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns
ICU Medical Inc is recalling 0.9% Sodium Chloride Injection bags because they may leak, compromising sterility. The recall covers lots distributed nationwide and in Canada.
Product
0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-37
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0886-2018·2018-06-27
Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurities
Dr. Reddy's Laboratories is recalling Atorvastatin Calcium tablets because they failed impurities and degradation specifications.
Product
ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0878-2018·2018-06-27
Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Foreign Object
Dr. Reddy's Laboratories is recalling 6,397 bottles of Atorvastatin Calcium 80 mg tablets because a foreign object was found embedded in a tablet.
Product
ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0888-2018·2018-06-27
Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurity Failures
Dr. Reddy's Laboratories is recalling 130,081 bottles of Atorvastatin Calcium 40 mg tablets nationwide due to failed impurity and degradation specifications.
Product
ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0887-2018·2018-06-27
Dr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Impurity Failures
Dr. Reddy's Laboratories is recalling specific lots of Atorvastatin Calcium tablets because they failed impurity and degradation specifications.
Product
ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0861-2018·2018-06-20
Acne Shave 3 Step Shaving System Recalled for Bacterial Contamination Risk
Shadow Holdings DBA Bocchi Labs is recalling the Acne Shave 3 Step Shaving System due to CGMP deviations that may result in bacterial contamination.
Product
Acne Shave 3 Step Shaving System, contains one tube Acne Shave (salicylic acid) Shave Cream Acne Shield, one tube Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5% tube, and one Power Shaver per box, Distributed by: United Exchange Corp., 17311 Valley View Blvd, Cerritos C
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0858-2018·2018-06-20
FDA Recalls X-Jow Pain Gel Due to Potential Bacterial Contamination
Shadow Holdings DBA Bocchi Labs is recalling X-Jow Pain Gel because CGMP deviations may have allowed bacterial contamination.
Product
X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC 850547 00502 6) and b) 8 oz. (226g) bottles (UPC 8 50547 00503 3, Distributed by Herb-X Solutions, Inc., 3838 West Burbank Blvd., Burbank CA 91505.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0875-2018·2018-06-20
Allergan Recalls Taytulla Contraceptive Softgels Due to Out-of-Sequence Tablets
Allergan is recalling Taytulla softgel capsules because the tablets are out of sequence. This affects 168,768 blister cards distributed nationwide.
Product
TAYTULLA — TAYTULLA (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE)
Category
Drug
Distribution
Distributed nationwide

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9576–9600 of 18028