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

8626–8650 of 17772

SevereFDA (Drugs)·D-0441-2019·2019-02-20
Promise Pharmacy Recalls Trim Complete Injection Due to Sterility Concerns
Promise Pharmacy is recalling 158 vials of Trim Complete injection nationwide due to a lack of sterility assurance.
Product
Trim Complete, Methlonine/Inositol/Choline/Thiamine/Riboflavin/Niacinamide Dexpanthenol/Pyridoxine/Methylcobalamin/Leucine/Chromium 25 mg/50 mg/50 mg/25 mg/2.5 mg/25 mg/2 mg/25 mg/0.5 mg2.5 mg/1.33 mcg/mL injection 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0459-2019·2019-02-20
Promise Pharmacy Recalls BPC 157 Injections Due to Sterility Concerns
Promise Pharmacy is recalling 37 vials of BPC 157 injections because they lack sterility assurance. The affected lot was distributed nationwide.
Product
BPC 157, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0454-2019·2019-02-20
Promise Pharmacy Recalls Ipamorelin and Sermorelin Injections Due to Sterility Concerns
Promise Pharmacy is recalling 139 vials of Ipamorelin and Sermorelin injections nationwide due to a lack of sterility assurance.
Product
Ipamorelin+Sermorelin, 15mg/15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0450-2019·2019-02-20
Promise Pharmacy Recalls Sermorelin Injection Due to Sterility Concerns
Promise Pharmacy is recalling 341 vials of Sermorelin/GHRP2/GHRP6 injection because the product lacks sterility assurance. The recall covers lots distributed nationwide in the USA.
Product
Sermorelin/GHRP2/GHRP6, 9 mg/9 mg/9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0438-2019·2019-02-20
Promise Pharmacy Recalls Vitamin B Complex Vials Due to Sterility Concerns
Promise Pharmacy is recalling 204 vials of compounded Vitamin B Complex due to a lack of sterility assurance. The product was distributed nationwide.
Product
Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine 2 mg/2.5 mg/25 mg/ 25 mg/ 2 mg/ 25 mg/mL 10 mL vial, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists, 31818 US Hwy 19N, Palm Harbor FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0462-2019·2019-02-20
Promise Pharmacy Recalls HCG Injections Due to Sterility Concerns
Promise Pharmacy is recalling 819 vials of HCG injections nationwide due to a lack of sterility assurance.
Product
HCG, Human chorionic gonadotropin 2,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0479-2019·2019-02-20
Promise Pharmacy Recalls Glycyrrhizic Acid Injection Due to Sterility Concerns
Promise Pharmacy, LLC is recalling specific lots of Glycyrrhizic Acid Injection because of a lack of sterility assurance. The affected product was distributed nationwide.
Product
Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0444-2019·2019-02-20
Promise Pharmacy Recalls Amino Blend Injection Due to Sterility Concerns
Promise Pharmacy is recalling 158 vials of Amino Blend Injection because the product lacks sterility assurance. The recall covers lots distributed nationwide.
Product
Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/10 mg/mL 10 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0448-2019·2019-02-20
Promise Pharmacy Recalls Sermorelin Theanine/GHRP2 Injection Due to Sterility Concerns
Promise Pharmacy is recalling Sermorelin Theanine/GHRP2 injections due to a lack of sterility assurance. The affected lot was distributed nationwide.
Product
Sermorelin Theanine/GHRP2, 15 mg/75 mg/5.4 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0477-2019·2019-02-20
Promise Pharmacy Recalls Lysine HCl Injection Due to Sterility Concerns
Promise Pharmacy, LLC is recalling 11 vials of Lysine HCl injection due to a lack of sterility assurance. The affected lot was distributed nationwide.
Product
Lysine HCl, 100 mg/mL injection, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0431-2019·2019-02-20
Promise Pharmacy Recalls Acetylcysteine Ophthalmic Solution Due to Sterility Concerns
Promise Pharmacy, LLC is recalling 75 bottles of Acetylcysteine Ophthalmic Solution because the product lacks sterility assurance. The recall covers nationwide distribution in the USA.
Product
Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34684.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0485-2019·2019-02-20
Dr. Reddy's Recalls Levetiracetam Injection Due to Labeling Error
Dr. Reddy's Laboratories is recalling Levetiracetam Injection bags because the primary label incorrectly identifies the product strength and sodium chloride concentration.
Product
LEVETIRACETAM — LEVETIRACETAM (LEVETIRACETAM INJECTION)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0464-2019·2019-02-20
Promise Pharmacy Recalls IGF-1-LR3 Injections Due to Sterility Concerns
Promise Pharmacy, LLC is recalling 59 vials of IGF-1-LR3, 3 mg injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.
Product
IGF-1-LR3, 3 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0494-2019·2019-02-20
Tris Pharma Recalls Superpotent Infant Ibuprofen Suspension
Tris Pharma is recalling specific lots of infant ibuprofen suspension because the medication may contain higher concentrations than labeled.
Product
infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-24.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0440-2019·2019-02-20
Promise Pharmacy Recalls Vitamin D3 Injections Due to Sterility Concerns
Promise Pharmacy is recalling specific lots of Vitamin D3 50,000iu/mL injections nationwide due to a lack of sterility assurance.
Product
Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0449-2019·2019-02-20
Promise Pharmacy Recalls Sermorelin Injections Due to Sterility Concerns
Promise Pharmacy, LLC is recalling 255 vials of Sermorelin 9 mg injection nationwide due to a lack of sterility assurance.
Product
Sermorelin 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0432-2019·2019-02-20
Promise Pharmacy Recalls Prednisolone and Moxifloxacin Eye Drops for Sterility Concerns
Promise Pharmacy is recalling 43 bottles of compounded Prednisolone and Moxifloxacin ophthalmic solution due to a lack of sterility assurance.
Product
Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0446-2019·2019-02-20
Promise Pharmacy Recalls Ascorbic Acid Injection Due to Sterility Concerns
Promise Pharmacy, LLC is recalling 196 vials of Ascorbic Acid Injection due to a lack of sterility assurance. The product was distributed nationwide.
Product
Ascorbic Acid, Compounded-Tapioca, 450 mg/mL Injection, 50 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0467-2019·2019-02-20
Promise Pharmacy Recalls MIC B12 Injection Due to Sterility Concerns
Promise Pharmacy, LLC is recalling MIC B12+L-Carnitine+Chromium injections due to a lack of sterility assurance. The recall covers 64 vials distributed nationwide.
Product
MIC B12+L-Carnitine+Chromium injection, Methionine Inositol Choline Methylcobalamin+L-Carnitine+Chromium, 25mg/50mg/50mg/1mg/100mg/0.4mcg/ml, 10mL, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0463-2019·2019-02-20
Promise Pharmacy Recalls Sermorelin Injections Due to Sterility Concerns
Promise Pharmacy is recalling 266 vials of Sermorelin 15mg injections because they lack sterility assurance. The products were distributed nationwide.
Product
Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0457-2019·2019-02-20
Promise Pharmacy Recalls Epithalon Injections Due to Sterility Concerns
Promise Pharmacy, LLC is recalling Epithalon 15mg injections due to a lack of sterility assurance. The affected lots were distributed nationwide.
Product
Epithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0466-2019·2019-02-20
Promise Pharmacy Recalls ICB-Complex Injections Due to Sterility Concerns
Promise Pharmacy is recalling 846 vials of ICB-Complex injection nationwide due to a lack of sterility assurance.
Product
ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/Chromium/Lidocaine: 25mg/25mg/5mg/2.5mg/25mg/5mg/5mg/0.1mg/1.5mg/25mg/25mg/10mg/ML, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0480-2019·2019-02-20
Promise Pharmacy Recalls Zinc Sulfate Injection Due to Sterility Concerns
Promise Pharmacy is recalling three vials of Zinc Sulfate injection due to a lack of sterility assurance. The product was distributed nationwide.
Product
Zinc Sulfate,10mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0495-2019·2019-02-20
Tris Pharma Recalls Superpotent Infants' Ibuprofen Suspension
Tris Pharma is recalling 35,280 bottles of Infants' Ibuprofen due to potential higher-than-labeled ibuprofen concentrations.
Product
Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39961 3, NDC 50428-1252-4.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0442-2019·2019-02-20
Promise Pharmacy Recalls Methylcobalamin Injection Due to Sterility Concerns
Promise Pharmacy is recalling 252 vials of Methylcobalamin Injection due to a lack of sterility assurance. The product was distributed nationwide.
Product
Methylcobalamin lyophilized 50,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide

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8626–8650 of 17772