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

5626–5650 of 11856

SevereFDA (Drugs)·D-0436-2019·2019-02-20
Promise Pharmacy Recalls Prednisolone Ophthalmic Solution for Sterility Concerns
Promise Pharmacy is recalling compounded Prednisolone and Gatifloxacin and Bromfenac ophthalmic solution due to lack of sterility assurance. The recall covers 900 bottles distributed nationwide.
Product
Prednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.09%, 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-0476-2019·2019-02-20
Promise Pharmacy Recalls Leucine/Isoleucine/Valine Injection Due to Sterility Concerns
Promise Pharmacy, LLC is recalling Leucine/Isoleucine/Valine injection vials due to a lack of sterility assurance. The affected products were distributed nationwide.
Product
Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0455-2019·2019-02-20
Promise Pharmacy Recalls Ipamorelin Injections Due to Sterility Concerns
Promise Pharmacy is recalling 93 vials of Ipamorelin injections nationwide due to a lack of sterility assurance.
Product
Ipamorelin, 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-0452-2019·2019-02-20
Promise Pharmacy Recalls Ipamorelin Injection Due to Sterility Concerns
Promise Pharmacy is recalling 927 vials of Ipamorelin+Modified GRF 1-29 injection because of a lack of sterility assurance.
Product
Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
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
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-0470-2019·2019-02-20
Promise Pharmacy Recalls Myer's Cocktail Vials Due to Sterility Concerns
Promise Pharmacy is recalling 5 vials of Myer's Cocktail due to a lack of sterility assurance. The product was distributed nationwide.
Product
Myer's Cocktail, Pyridoxine/Dexpanthenol/Calcium Gluconate/Niacinamide/Vit B6/Vit B1/Leucine/Vit B5/Riboflavin/Ascorbic Acid/Hydroxycobalamin/Magnesium Chloride, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0458-2019·2019-02-20
Promise Pharmacy Recalls Bremelanotide Injections Due to Sterility Concerns
Promise Pharmacy is recalling 64 vials of Bremelanotide 20mg injections nationwide due to a lack of sterility assurance.
Product
Bremelanotide (PT 141), 20mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0465-2019·2019-02-20
Promise Pharmacy Recalls Melanotan II Injections Due to Sterility Concerns
Promise Pharmacy is recalling 43 vials of Melanotan II injections because the product lacks sterility assurance. The affected lots were distributed nationwide.
Product
Melanotan II, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0475-2019·2019-02-20
Promise Pharmacy Recalls Pyridoxine HCl Injection Due to Sterility Concerns
Promise Pharmacy, LLC is recalling 8 vials of Pyridoxine HCl Injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.
Product
Pyridoxine HCl, 100 mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0456-2019·2019-02-20
Promise Pharmacy Recalls IGF-1 LR3 Injections Due to Sterility Concerns
Promise Pharmacy is recalling 59 vials of IGF-1 LR3 injections because they lack sterility assurance. The affected products were distributed nationwide.
Product
IGF-1 LR3, 620 mcg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0500-2019·2019-02-13
Nature's Rx Silver Bullet 10x Capsules Recalled for Undeclared Sildenafil and Tadalafil
Nature's Rx is recalling Silver Bullet 10x Capsules sold on eBay because FDA analysis found undeclared sildenafil and tadalafil.
Product
the silver bullet 10x Capsules, 725 mg each (proprietary blend of: Mucuna Pruriens Extract, Horny Goat Weed, Ginger Root Extract, Icariin, Wolf Berry (fruit) Lactase, Tribulus Terrestris Extract, Piperine), 10 count mylar package, Nature's Rx, Claremont, CA
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0424-2019·2019-02-13
Mylan Recalls Dymista Nasal Spray Due to Broken Glass Risk
Mylan Pharmaceuticals is recalling 10,390 bottles of Dymista nasal spray because the glass bottles may have broken glass in the neck area.
Product
DYMISTA — DYMISTA (AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0413-2019·2019-02-06
Prinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
Prinston Pharmaceutical Inc is recalling Irbesartan and Hydrochlorothiazide tablets because FDA labs found the impurity NDEA above acceptable levels.
Product
IRBESARTAN AND HYDROCHLOROTHIAZIDE — IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0410-2019·2019-02-06
Prinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
Prinston Pharmaceutical Inc. is recalling Irbesartan and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA) above acceptable levels.
Product
IRBESARTAN AND HYDROCHLOROTHIAZIDE — IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0411-2019·2019-02-06
Prinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
Prinston Pharmaceutical Inc. is recalling Irbesartan and Hydrochlorothiazide tablets because FDA testing found N-nitrosodimethylamine (NDEA) above the acceptable daily intake level.
Product
IRBESARTAN AND HYDROCHLOROTHIAZIDE — IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0409-2019·2019-02-06
Prinston Recalls Irbesartan Tablets Due to NDEA Impurity
Prinston Pharmaceutical Inc. is recalling Irbesartan 300 mg tablets because FDA testing found N-nitrosodimethylamine (NDEA) levels above the interim acceptable daily intake.
Product
IRBESARTAN — IRBESARTAN (IRBESARTAN)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0412-2019·2019-02-06
Prinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
Prinston Pharmaceutical Inc. is recalling Irbesartan and Hydrochlorothiazide tablets because FDA testing found the impurity NDEA above acceptable limits.
Product
IRBESARTAN AND HYDROCHLOROTHIAZIDE — IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0423-2019·2019-02-06
Lupin Recalls Cephalexin Oral Suspension Due to CGMP Deviations
Lupin Pharmaceuticals is recalling 14,400 bottles of Cephalexin for Oral Suspension due to CGMP deviations and the presence of extraneous material in sucrose excipients.
Product
CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
Category
Drug
Distribution
0 states
HighFDA (Drugs)·D-0422-2019·2019-02-06
BromSite Ophthalmic Solution Recalled for Lack of Sterility Assurance
Sun Pharmaceutical is recalling BromSite (bromfenac) 0.075% ophthalmic solution due to a lack of sterility assurance. The recall affects 69,840 bottles distributed nationwide.
Product
BROMSITE — BROMSITE (BROMFENAC)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0388-2019·2019-01-30
5K Premium Enhancement capsules recalled for undeclared sildenafil and tadalafil
Happy Together, Inc. is recalling 5K Premium Enhancement capsules because FDA analysis found undeclared sildenafil and tadalafil.
Product
5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL UPC 649964965644
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0383-2019·2019-01-30
Bound Tree Medical Recalls Epi Safe Kits Due to Incorrect Instructions
Bound Tree Medical is recalling Epi Safe Administration and Training Kits because the instructions recommend an unapproved epinephrine dosage for young children.
Product
curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 Epi Safe Administration Kit (8600-01101), 1 Epi Safe Training Kit (8600-01102), Rx Only, Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Me
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0386-2019·2019-01-30
Bound Tree Medical Recalls Curaplex Epi Kits Due to Incorrect Instructions
Bound Tree Medical is recalling 339 Curaplex Epi Kits because the instructions recommend an unapproved epinephrine dosage for young children.
Product
Curaplex Epi Kit NOT FOR IV USE, #8600-01120, Epi-Safe Kit 8600-01 120 contains:2 Safety-LOK Syringe, TB, 1cc w/ needle, 25 ga x5/8 , 2 Vials of epinephrine, 1mg/1mL, 4 Alcohol prep pads, 2 Adhesive bandages, 1 x 3 1 Epi Generic Injection. Rx Only. Distributed by Sarnova HC, L
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0384-2019·2019-01-30
Recall of Curaplex Epi Safe Kits Due to Incorrect Epinephrine Instructions
Bound Tree Medical is recalling Curaplex Epi Safe Kits because the instructions recommend an unapproved epinephrine dosage for young children.
Product
curaplex Epi Safe Kit, 8600-01101, contains:" 1ml Vial of Epinephrine " 1 Epi-Safe Syringe " 1 Safety Needle " 2 Alcohol Prep Pads " 1 Adhesive Dressing " 1 Insert, Rx Only. Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Eme
Category
Medical Device
Distribution
Distributed nationwide

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5626–5650 of 11856