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

6726–6750 of 11823

SevereFDA (Drugs)·D-0879-2017·2017-06-07
SCA Pharmaceuticals Recalls Phenylephrine Injectable Bags Due to Leaking
SCA Pharmaceuticals is recalling 30 bags of Phenylephrine HCL injectable solution because the bags are leaking at the seam, compromising sterility.
Product
PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Container bag, Preservative Free (Contains Sulfites), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0810-32
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0873-2017·2017-06-07
SCA Pharmaceuticals Recalls Fentanyl Injection Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling 370 bags of fentanyl injection solution because the bags were leaking at the seam, compromising sterility.
Product
fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0202-32
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0862-2017·2017-05-31
Hospira Recalls Dextrose Injection Syringes Due to Human Hair Particulate
Hospira is recalling 71,550 syringes of Infant 25% Dextrose Injection because human hair was found in an internal sample. The product was distributed nationwide and in Puerto Rico.
Product
DEXTROSE — DEXTROSE (DEXTROSE MONOHYDRATE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0867-2017·2017-05-31
Envy Me Recalls LaBri's Body Health Atomic Due to Undeclared Sibutramine
Envy Me is recalling LaBri's Body Health Atomic capsules because the product contains undeclared Sibutramine and was marketed without an approved NDA/ANDA.
Product
LaBri's Body Health Atomic, 60 capsules
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0864-2017·2017-05-31
Hyland's Baby Nighttime Teething Tablets Recalled for Inconsistent Belladonna Alkaloids
Standard Homeopathic Company is recalling Hyland's Baby Nighttime Teething Tablets because FDA analysis found inconsistent amounts of belladonna alkaloids.
Product
Hyland's Baby Nighttime Teething Tablets [Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated), Calcarea Phosphorica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Magnesia Phosphorica 6X HPUS, Rheum 6X HPUS, Silicea 12X HPUS] Quick-Dissolving Tablets, 135-count bottl
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0863-2017·2017-05-31
Hyland's Baby Teething Tablets Recalled for Inconsistent Belladonna Alkaloid Levels
Standard Homeopathic Company is recalling Hyland's Baby Teething Tablets because FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from label claims.
Product
Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated)] Quick-Dissolving Tablets, packaged in a) 40-count bottles (NDC 54973-3127-3) (UPC 3 54973 31273 9); b) 135-count bo
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0854-2017·2017-05-31
Sato Pharmaceutical Recalls Optic Splash Eye Drops Due to Sterility Concerns
Sato Pharmaceutical Inc. is recalling 10,130 bottles of Optic Splash eye drops because the firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Product
Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-501-01.
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0856-2017·2017-05-31
Sato Pharmaceutical Recalls DORAMA-NEO Eye Wash Due to Sterility Concerns
Sato Pharmaceutical Inc. is recalling 14,325 bottles of DORAMA-NEO eye wash because the manufacturer failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Product
DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-020-01
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0855-2017·2017-05-31
Sato Clear Eye Drops Recalled for Sterility Assurance Failure
Sato Pharmaceutical is recalling Sato Clear eye drops because the firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Product
SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-044-01
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-0793-2017·2017-05-31
GlaxoSmithKline Recalls Ventolin HFA Inhalers Due to Defective Delivery System
GlaxoSmithKline is recalling specific lots of Ventolin HFA inhalers because some units have out-of-specification leak rates.
Product
VENTOLIN — VENTOLIN (ALBUTEROL SULFATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0788-2017·2017-05-24
Baxter Recalls Fluconazole Injection Bags Due to Sterility Concerns
Baxter Healthcare is recalling Fluconazole Injection bags because customer complaints indicated leaks that compromise sterility assurance.
Product
FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0768-2017·2017-05-24
Key Pharmacy Recalls Magnesium Sulfate Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Magnesium Sulfate 50% injections because the firm cannot assure the sterility of the product.
Product
MAGNESIUM SO4 10ML MDV 50% INJ, Injection, 50%, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0735-2017·2017-05-24
Key Pharmacy Recalls TRI MIX Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling TRI MIX 10/15/1 5ML MDV MCG/MG/MG/ML INJ due to a lack of assurance of sterility.
Product
TRI MIX 10/15/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/1mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0756-2017·2017-05-24
Key Pharmacy Recalls PGE1/Procaine Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of PGE1/Procaine injections because the firm cannot guarantee the products are sterile.
Product
PGE1/PROCAINE 5ML MDV 20MCG/ML/0.1% INJ, Injection, 20mcg/ml 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0718-2017·2017-05-24
Key Pharmacy Recalls Folinic Acid Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Folinic Acid injections because the firm cannot guarantee the products are sterile.
Product
FOLINIC ACID MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 5 mL and10 mL glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0764-2017·2017-05-24
Key Pharmacy Recalls Iron Special Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling Iron Special 5mL multiple-dose vials due to a lack of assurance of sterility.
Product
IRON SPECIAL 5ML MDV 60/10MG/5MCG/ML INJ, Injection, 60mg/1mg/5mcg/mL, Rx only, 5mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0724-2017·2017-05-24
Key Pharmacy Recalls Hydroxo-B12 Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot ensure the products are sterile.
Product
HYDROXO-B12 10ML PBF MDV 5MG/ML INJ, 5mg/mL, Rx only, 10 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 30ML PBF MDV 5MG/ML INJ, 5mg/mL, RX only, 30 mL Glass/ Multiple Dose vial.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0750-2017·2017-05-24
FDA Recalls Key Pharmacy Compounded Sterile Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling TRI MIX sterile compounded injections due to a lack of assurance of sterility. The affected vials were distributed in the U.S., Australia, and Canada.
Product
TRI MIX 5.88/17.65/0.588 5ML MDV MCG/MG/MG/ML INJ, , Injection, 5.88mcg/17.65mg/0.588mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0778-2017·2017-05-24
Key Pharmacy Recalls Sodium Bicarbonate Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Sodium Bicarbonate Injection because the firm cannot guarantee the product is sterile.
Product
SODIUM BICARB 50ML MDV 8.4% (2 MOSMOL/ML) INJ, Injection, 8.40%, Rx only, 5mL Glass/Multiple Dose via, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0736-2017·2017-05-24
Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling TRI MIX 10/15/2.5 5ML MDV MCG/MG/MG/ML INJ due to lack of assurance of sterility.
Product
TRI MIX 10/15/2.5 5ML MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/2.5mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0729-2017·2017-05-24
Key Pharmacy Recalls Papaverine/Phentolamine Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Papaverine/Phentolamine injections because the firm cannot assure the sterility of the product.
Product
PAPAVERINE/PHENT 5ML MDV 30/0.5MG/ML INJ, Injection, 30/0.5mg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0715-2017·2017-05-24
Key Pharmacy Recalls DMSO 6.25% Ophthalmic Solution Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling DMSO 6.25% Ophthalmic Solution because the firm cannot ensure the product is sterile.
Product
DMSO 6.25% OPHTH., 6.25%, Rx only, 15 mL plastic/Multiple Dose bottle, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0744-2017·2017-05-24
Key Pharmacy Recalls Sterile Compounded Injection Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of TRI MIX 20/30/1 injection due to a lack of assurance of sterility.
Product
TRI MIX 20/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0784-2017·2017-05-24
Key Pharmacy Recalls Vitamin B Complex Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Vitamin B Complex injections because the firm cannot guarantee the products are sterile.
Product
VITAMIN B COMPLEX 1ML SDV NA INJ, Injection, 100mg/2mg/2mg/2mg/100mg/mL, Rx only, 1mL Glass; Single Dose, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0721-2017·2017-05-24
Key Pharmacy Recalls Hydroxo-B12 Injections Due to Sterility Concerns
Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot ensure the products are sterile.
Product
HYDROXO-B12 *1ML* SDV 1MG/ML INJ, Injection, 1mg/mL, Rx only, 1 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
Category
Drug
Distribution
Distributed nationwide

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6726–6750 of 11823