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

8176–8200 of 11823

SevereFDA (Drugs)·D-0341-2016·2015-11-25
Downing Labs Recalls Acetyl-L-Carnitine Injectable Due to Sterility Concerns
Downing Labs, LLC is recalling Acetyl-L-Carnitine and L-Carnitine injectable vials due to a lack of assurance of sterility. The products were distributed nationwide and internationally.
Product
Acetyl-L-Carnitine Injectable, 100mg/mL, 30mL vial, L-Carnitine Injection 500mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0270-2016·2015-11-25
US Compounding Recalls Morphine PF Vials Due to Sterility Concerns
US Compounding Inc is recalling 5,919 vials of Morphine PF due to deficient practices that may impact sterility assurance.
Product
Morphine PF (2 mg/2 mL), 2 mL Single Use Vial, For IV or IM Administration, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2171-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-315-2016·2015-11-25
Essential Wellness Recalls Methylcobalamin Injections Due to Sterility Concerns
Essential Wellness Pharmacy is recalling Methylcobalamin 5000 mcg/mL injections due to poor sterile production practices that compromised sterility assurance.
Product
Methylcobalamin 5000 mcg/mL Preservative Free Injection, packaged in a) 4 mL and b) 8 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-321-2016·2015-11-25
Progesterone Injection Recalled for Lack of Sterility Assurance
Essential Wellness Pharmacy is recalling Progesterone 100 mg/mL injections due to poor sterile production practices that compromised sterility assurance.
Product
Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0363-2016·2015-11-25
Downing Labs Recalls Calcium Gluconate Injection Due to Sterility Concerns
Downing Labs, LLC is recalling 286 vials of Calcium Gluconate Injection 10% because the company cannot ensure the product is sterile.
Product
Calcium Gluconate (680mOsm/L) Injection 10%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-309-2016·2015-11-25
Essential Wellness Pharma Recalls HCG Injection Due to Sterility Concerns
Essential Wellness Pharma is recalling HCG 3000 Units/mL Injection vials due to poor sterile production practices that compromised sterility assurance.
Product
HCG 3000 Units/mL Injection, 2 mL vial, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-301-2016·2015-11-25
Essential Wellness Pharma Recalls BIMIX INJ Injection Due to Sterility Concerns
Essential Wellness Pharma is recalling BIMIX INJ 30 mg-1 mg/mL Injection vials because poor sterile production practices resulted in a lack of sterility assurance.
Product
BIMIX INJ 30 mg-1 mg/mL Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0380-2016·2015-11-25
Downing Labs Recalls Potassium Chloride Injection Due to Sterility Concerns
Downing Labs, LLC is recalling 225 vials of Potassium Chloride Injection due to a lack of assurance of sterility. The product was distributed nationwide and in multiple international markets.
Product
Potassium Chloride Injection (20mEq/10mL), 2mEq/ML, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0256-2016·2015-11-25
US Compounding Recalls Hyaluronic Acid Syringes Due to Sterility Concerns
US Compounding Inc is recalling 531 hyaluronic acid and lidocaine syringes because deficient practices may have impacted sterility assurance.
Product
Hyaluronic Acid/Lidocaine PF (60 mg/2%), 3 mL Single Use Syringe, For Intra-Articular Injection , Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3249-03
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-313-2016·2015-11-25
Essential Wellness Pharma Recalls LIPO-B Special Injection Due to Sterility Concerns
Essential Wellness Pharma is recalling LIPO-B Special Injection vials because poor sterile production practices created a lack of sterility assurance.
Product
LIPO-B Special Injection,12 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0241-2016·2015-11-25
US Compounding Recalls Betamethasone Vials Due to Sterility Concerns
US Compounding Inc is recalling 6,008 vials of Betamethasone SP PF due to deficient practices that may impact sterility assurance.
Product
Betamethasone SP PF (12 mg/mL), 2 mL Single Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3016-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0239-2016·2015-11-25
US Compounding Recalls Betamethasone Vials Due to Sterility Concerns
US Compounding Inc is recalling 5,514 vials of Betamethasone Combo PF 2 mL due to deficient practices that may impact sterility assurance.
Product
Betamethasone Combo PF 2 mL (6 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-306-2016·2015-11-25
Essential Wellness Pharma Recalls HCG Injections Due to Sterility Concerns
Essential Wellness Pharma is recalling 49 vials of HCG 1000 Units/mL injections nationwide due to poor sterile production practices that compromise sterility assurance.
Product
HCG 1000 Units/mL SUB-Q Injection, packaged in a)1.5 mL, b) 2 mL, c) 2.4 mL, d) 4 mL, e) 6 mL, f) 7.5 mL, g) 8 mL, and h) 9 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0337-2016·2015-11-25
Downing Labs Recalls L-Glutamine Injectable Due to Sterility Concerns
Downing Labs, LLC is recalling L-Glutamine Injectable vials because the company cannot assure the product's sterility. The recall covers all lots distributed in the US and internationally.
Product
L-Glutamine Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0261-2016·2015-11-25
US Compounding Recalls Lidocaine Syringes Due to Sterility Assurance Concerns
US Compounding Inc is recalling 7,320 syringes of Lidocaine 1% PF for IV injection because deficient practices may have impacted sterility assurance.
Product
Lidocaine 1% PF(100 mg/10 mL),10 mL Single Use Syringe, For IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3099-07
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0271-2016·2015-11-25
US Compounding Recalls Neostigmine Syringes Due to Sterility Concerns
US Compounding Inc is recalling 15,640 vials of Neostigmine 5 mg/5 mL syringes nationwide due to deficient practices that may impact sterility assurance.
Product
Neostigmine (5 mg/5 mL), 5 mL Single Use Syringe, For IM, SC or Slow IV Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3132-05
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0384-2016·2015-11-25
Downing Labs Recalls Methylcobalamin Injection Due to Sterility Concerns
Downing Labs, LLC is recalling 315 vials of Methylcobalamin Injection Buffered 5mg/mL due to a lack of assurance of sterility. The product was distributed nationwide and internationally.
Product
Methylcobalamin Injection Buffered 5mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0362-2016·2015-11-25
Downing Labs Recalls TNPDR Injection Buffered Due to Sterility Concerns
Downing Labs, LLC is recalling 481 vials of TNPDR Injection Buffered because the company cannot ensure the product is sterile. The recall covers all lots distributed nationwide and internationally.
Product
TNPDR Injection Buffered, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0279-2016·2015-11-25
US Compounding Recalls Prednisolone Eye Drops Due to Sterility Concerns
US Compounding Inc is recalling Prednisolone Sodium Phosphate eye drops due to deficient practices that may impact sterility assurance.
Product
Prednisolone Sodium Phosphate PF Solution (1%) in 15 mL dropper bottle; For Topical Ophthalmic Use, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0351-2016·2015-11-25
Downing Labs Recalls Cyanocobalamin Injectable Due to Sterility Concerns
Downing Labs, LLC is recalling Cyanocobalamin Buffered Injectable 3mg/mL vials because the company cannot ensure the product is sterile.
Product
Cyanocobalamin Buffered Injectable 3mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0338-2016·2015-11-25
Downing Labs Recalls L-Tyrosine Injectable Due to Sterility Concerns
Downing Labs, LLC is recalling 29 vials of L-Tyrosine Injectable because the product lacks assurance of sterility. The affected product was distributed nationwide and in multiple international markets.
Product
L-Tyrosine Injectable, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0348-2016·2015-11-25
Downing Labs Recalls Methylcobalamin Injectable Due to Sterility Concerns
Downing Labs is recalling Methylcobalamin Buffered Injectable vials because the company cannot guarantee the product is sterile.
Product
Methylcobalamin Buffered Injectable, 1mg/mL, packaged in a) 10mL vial, b) 30mL Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-327-2016·2015-11-25
Essential Wellness Recalls Testosterone Cypionate Injection Due to Sterility Concerns
Essential Wellness Pharmacy is recalling Testosterone Cypionate 50 mg/mL injections due to poor sterile production practices that compromise sterility assurance.
Product
Testosterone Cypionate 50 mg/mL Injection, 1 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0343-2016·2015-11-25
Downing Labs Recalls MICML TRNDPPC Injection Due to Sterility Concerns
Downing Labs, LLC is recalling MICML TRNDPPC Injection (Preserved) 10mL vials because the company cannot ensure the product is sterile.
Product
MICML TRNDPPC Injection (Preserved) 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-304-2016·2015-11-25
Essential Wellness Pharma Recalls Dual Test Cyp/ena Injection Due to Sterility Concerns
Essential Wellness Pharma is recalling Dual Test Cyp/ena Injection vials because poor sterile production practices resulted in a lack of sterility assurance.
Product
DUAL TEST CYP/ENA 1:1 200 mg/mL Injection, packaged in a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Category
Drug
Distribution
Distributed nationwide

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8176–8200 of 11823