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

6126–6150 of 11856

SevereFDA (Drugs)·D-0911-2018·2018-07-11
Fagron Recalls Neostigmine Methylsulfate Syringes Due to Labeling Error
Fagron Compounding Services is recalling 390 prefilled syringes of Neostigmine Methylsulfate Injection Solution because some may be incorrectly labeled with the wrong strength.
Product
Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-01.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0891-2018·2018-07-11
Ingenus Recalls Irinotecan Hydrochloride Injection Due to Potency Issues
Ingenus Pharmaceuticals is recalling Irinotecan Hydrochloride Injection because of high out-of-specification assay values for potency.
Product
IRINOTECAN HYDROCHLORIDE — IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0895-2018·2018-07-11
SCA Pharmaceuticals Recalls Fentanyl Bags Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling 492 bags of Fentanyl admixture due to a potential for leakage that compromises sterility.
Product
Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0894-2018·2018-07-11
SCA Pharmaceuticals Recalls Morphine Sulfate Syringes Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling specific lots of Morphine Sulfate 1 mg/mL syringes due to a potential for leakage that compromises sterility.
Product
Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
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-0897-2018·2018-07-11
SCA Pharmaceuticals Recalls Diltiazem HCL Bags Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling specific lots of Diltiazem HCL sterile admixtures due to a potential for leakage that compromises sterility.
Product
Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0898-2018·2018-07-11
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 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0903-2018·2018-07-11
SCA Pharmaceuticals Recalls Phenylephrine HCL Bags Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling 400 bags of Phenylephrine HCL 20 mg in 0.9% Sodium Chloride due to a potential for leakage that compromises sterility.
Product
Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0902-2018·2018-07-11
SCA Pharmaceuticals Recalls Phenylephrine Bags Due to Sterility Concerns
SCA Pharmaceuticals is voluntarily recalling 451 bags of Phenylephrine HCL due to potential leakage that compromises sterility.
Product
Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Category
Drug
Distribution
0 states
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
SevereFDA (Drugs)·D-0890-2018·2018-07-11
Ingenus Recalls Irinotecan Hydrochloride Injection Due to Potency Issues
Ingenus Pharmaceuticals is recalling specific lots of Irinotecan Hydrochloride Injection because they had high out-of-specification assay values for potency.
Product
IRINOTECAN HYDROCHLORIDE — IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
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-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
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
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-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
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-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-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-0860-2018·2018-06-20
Acne Shave Shave Cream Recalled for Potential Bacterial Contamination
Shadow Holdings DBA Bocchi Labs is recalling Acne Shave Shave Cream due to CGMP deviations that may allow bacterial contamination.
Product
Acne Shave (salicylic acid) Shave Cream Acne Shield, 0.5%, 5.1 FL OZ (150 mL) tube, Distributed by: United Exchange Corp., 17311 Valley View Blvd, Cerritos, CA 90703 USA, UPC 7 80707 73111 6.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0864-2018·2018-06-20
Inopak Recalls Antibacterial Foaming Hand Wash Due to Microbial Contamination
Inopak Ltd is recalling Option Systems Antibacterial Foaming Hand Wash because FDA analysis found out-of-specification microbial counts.
Product
Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ
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

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6126–6150 of 11856