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

476–500 of 810

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
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-0690-2017·2017-05-10
EpiPen Auto-Injectors Recalled for Defective Delivery System
Meridian Medical Technologies is recalling EpiPen auto-injectors because the delivery system may fail to activate, preventing patients from receiving epinephrine.
Product
EPIPEN — EPIPEN (EPINEPHRINE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0691-2017·2017-05-10
EpiPen Jr. Auto-Injectors Recalled for Delivery System Defects
Meridian Medical Technologies is recalling EpiPen Jr. auto-injectors because the delivery system may fail to activate, preventing patients from receiving epinephrine.
Product
EPIPEN — EPIPEN (EPINEPHRINE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0640-2017·2017-04-12
SCA Pharmaceuticals Recalls Vancomycin IV Bags Due to Particulate Matter
SCA Pharmaceuticals is recalling specific lots of Vancomycin HCl IV bags due to the presence of particulate matter, following a related Hospira recall.
Product
Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0920-59
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0644-2017·2017-04-12
SCA Pharmaceuticals Recalls Vancomycin IV Bags Due to Particulate Matter
SCA Pharmaceuticals is recalling Vancomycin HCl IV bags due to the presence of particulate matter, linked to a related Hospira recall.
Product
Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0929-40
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0646-2017·2017-04-12
FDA Recalls XtraHRD Male Enhancement Capsules for Unapproved Drug Ingredient
Organic Herbal Supply is recalling XtraHRD Natural Male Enhancement Capsules because they contain N-desmethyl tadalafil, an unapproved drug ingredient.
Product
XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg capsules, 2, 4 and 10 count boxes, Made in Malaysia, Distributed by Naturally Hard Supplements, Reno, NV 89503, UPC 680474228768
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0642-2017·2017-04-12
SCA Pharmaceuticals Recalls Vancomycin IV Bags Due to Particulate Matter
SCA Pharmaceuticals is recalling 490 bags of Vancomycin HCl IV solution due to the presence of particulate matter, linked to a related Hospira recall.
Product
Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0924-59
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0637-2017·2017-04-12
X-Gen Recalls Ibuprofen Lysine Injection Due to Particulate Matter
X-Gen Pharmaceuticals is recalling 2,593 cartons of Ibuprofen Lysine Injection because of the presence of particulate matter. The affected product was distributed nationwide in the USA.
Product
IBUPROFEN LYSINE — IBUPROFEN LYSINE (IBUPROFEN LYSINE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0505-2017·2017-03-08
Pacific Medical Solutions Recalls Nano PNC Water Due to Bacterial Contamination
Pacific Medical Solutions is recalling Nano PNC Water because it was marketed without FDA approval and tested positive for the bacterium variovorax paradoxus.
Product
Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immune Cellular Restoration Program.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0494-2017·2017-03-08
Jeffreys Drug Store Recalls Compounded Domperidone Capsules 10 mg
Jeffreys Drug Store is recalling compounded Domperidone capsules 10 mg because the product was marketed without an approved NDA/ANDA, meaning safety and efficacy have not been established.
Product
Domperidone capsules 10 mg, compounded, dispensed in 60, 90, and 360 count bottles, Jeffreys Drug Store 1 North Central Ave. Canonsburg, PA
Category
Drug
Distribution
1 state
CriticalFDA (Drugs)·D-0496-2017·2017-03-08
United Exchange Recalls Non-Sterile Eye Wash Bottles Nationwide
United Exchange Corporation is recalling 46,080 bottles of Eye Wash due to direct evidence of non-sterility contamination in two lots.
Product
EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0904-6491-20
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0472-2017·2017-02-22
MS Bionic Recalls MegaJex Herbal Supplement Containing Unapproved ED Drugs
MS Bionic is recalling MegaJex Herbal Supplement because it contains sildenafil and tadalafil, active ingredients in approved erectile dysfunction drugs, without FDA approval.
Product
MegaJex Herbal Supplement, Maximum Formula for Men, Fast acting, Increase Stamina, 20 capsules, MS Bionics, Gardena, CA
Category
Drug
Distribution
1 state
CriticalFDA (Drugs)·D-0216-2017·2016-12-28
Honeywell Eyesaline Eyewash Recalled for Klebsiella Pneumoniae Contamination
Sperian Eye & Face Protection is recalling 9,744 bottles of Honeywell Eyesaline Eyewash Sterile Isotonic Solution due to non-sterility and contamination with Klebsiella pneumoniae.
Product
Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.), Sperian Eye & Face Protection, Inc. (a Honeywell Company), Platteville, WI 53818
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0223-2017·2016-12-28
Skinny Bee Diet capsules recalled for undeclared dangerous ingredients
Love My Tru Body is recalling Skinny Bee Diet capsules because they contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein.
Product
Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0229-2017·2016-12-28
Sage Products Recalls Comfort Shield Barrier Cream Cloths Due to Bacteria
Sage Products LLC is recalling Comfort Shield Barrier Cream Cloths because they are contaminated with Burkholderia cepacia bacteria.
Product
COMFORT SHIELD BARRIER — COMFORT SHIELD BARRIER (DIMETHICONE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0210-2017·2016-12-28
Ultimate Body Tox PRO capsules recalled for undeclared sibutramine
FDA is recalling Ultimate Body Tox PRO capsules because they contain undeclared sibutramine, a controlled substance removed from the market for safety reasons.
Product
Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0221-2017·2016-12-28
FDA Recalls Black Gold X Advanced Capsules for Undeclared Sibutramine
The FDA is recalling Black Gold X Advanced capsules because they contain undeclared sibutramine and were marketed without an approved NDA/ANDA.
Product
BLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0211-2017·2016-12-28
Guardian Pharmacy Recalls Lidocaine Syringes Due to Failed Sterility Test
Guardian Pharmacy Services is recalling 180 pre-filled Lidocaine HCL/Sodium Bicarb syringes because a sterility test failed. The product was distributed to two medical facilities in Texas.
Product
Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only
Category
Drug
Distribution
1 state
CriticalFDA (Drugs)·D-0220-2017·2016-12-28
FDA Recalls Black Label X Capsules for Undeclared Sildenafil
Making It a Lifestyle is recalling 1,000 bottles of Black Label X capsules nationwide because they contain undeclared sildenafil and were marketed without FDA approval.
Product
BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0228-2017·2016-12-28
Sermorelin/GHRP-6 Injection Recalled for Non-Sterility and Microbial Contamination
Town and Country Compounding and Consultation Services is recalling Sermorelin/GHRP-6 Injection due to non-sterility and Bacillus circulans contamination.
Product
Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services, Ridgewood, NJ 074502
Category
Drug
Distribution
4 states
CriticalFDA (Drugs)·D-0218-2017·2016-12-28
Hospira Recalls Bupivacaine Hydrochloride Vials Due to Particulate Matter
Hospira Inc. is recalling 143,250 vials of Bupivacaine Hydrochloride Injection due to a confirmed report of particulate matter in a single vial.
Product
BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0101-2017·2016-10-26
Tiger-X Dietary Supplement Recalled for Undeclared Sildenafil
SOS Telecom Inc. is recalling Tiger-X dietary supplements because FDA testing found undeclared sildenafil or analogs. The product was marketed without an approved NDA or ANDA.
Product
Tiger-X, 1200 mg, 1 capsule per pack , 24 single packs per box
Category
Drug
Distribution
1 state
CriticalFDA (Drugs)·D-0104-2017·2016-10-26
Dietary Supplement Recalled for Undeclared Sildenafil and Analogs
SOS Telecom Inc. is recalling Super Samurai-X dietary supplements because FDA testing found undeclared sildenafil and/or its analogs.
Product
Super Samurai-X , 1000 mg, 1 capsule per pack , 24 single packs per box.
Category
Drug
Distribution
1 state
CriticalFDA (Drugs)·D-0103-2017·2016-10-26
Ginseng Power-X Recalled for Undeclared Sildenafil
SOS Telecom Inc. is recalling Ginseng Power-X capsules because FDA testing found undeclared sildenafil or analogs.
Product
Ginseng Power-X , 1800 mg, 1 capsule per pack , 24 single packs per box.
Category
Drug
Distribution
1 state

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