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

8751–8775 of 17974

ModerateFDA (Drugs)·D-0427-2019·2019-02-13
Medline Remedy Barrier Ointment Recalled for Microbial Contamination
US Pharmaceuticals is recalling Medline Remedy Barrier Skin Protectant Ointment due to out-of-specification microbial counts in purified water.
Product
Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for Medline Industries Inc., Mundelien, IL 60060.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0425-2019·2019-02-13
US Pharmaceuticals Recalls Soothe & Cool Protect Moisture Guard Skin Protectant
US Pharmaceuticals is recalling Soothe & Cool Protect Moisture Guard Skin Protectant due to out-of-specification microbial counts in purified water.
Product
Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mundelein, IL 60060 USA NDC 53329-303-22
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0429-2019·2019-02-13
Lupin Recalls Bimatoprost Ophthalmic Solution Due to Impurity Failures
Lupin Pharmaceuticals is recalling Bimatoprost Ophthalmic Solution 0.03% because out-of-specification results were observed for individual and total impurities.
Product
Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles, Rx only, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA.
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-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-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-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
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-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
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
ModerateFDA (Drugs)·D-0414-2019·2019-02-06
Akorn Recalls Gentamicin Sulfate Ophthalmic Solution Due to Particulate Matter
Akorn, Inc. is recalling specific lots of Gentamicin Sulfate Ophthalmic Solution because crystalline particles were detected during clarity testing.
Product
Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0416-2019·2019-02-06
Duren Health Mart Pharmacy Recalls Omeprazole Suspension Due to Processing Controls
Duren Health Mart Pharmacy is recalling Omeprazole 4 mg/mL Suspension because of a lack of processing controls. The recall is limited to Tennessee.
Product
Omeprazole 4 mg/mL Suspension, 150cc to 300 cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00000-0001-07
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0417-2019·2019-02-06
Progesterone Cream Recalled for Lack of Processing Controls
Duren Health Mart Pharmacy is recalling Progesterone 10% cream due to a lack of processing controls. The product was distributed in Tennessee.
Product
Progesterone 10% cream, 12gm to 30gm per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00000-0002-99
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0418-2019·2019-02-06
Testosterone Cream Recalled for Lack of Processing Controls
Duren Health Mart Pharmacy is recalling Testosterone 0.1% cream due to a lack of processing controls. The product was distributed in Tennessee.
Product
Testosterone 0.1% cream, 30 grams, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00000-0000-98
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0419-2019·2019-02-06
Promethazine Gel Recalled by Duren Health Mart Pharmacy for Processing Control Issues
Duren Health Mart Pharmacy is recalling Promethazine Gel 50 mg/mL due to a lack of processing controls. The affected product was distributed in Tennessee.
Product
Promethazine Gel 50 mg/mL, 1cc to 10cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00002-1901-03
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0415-2019·2019-02-06
Gentamicin Ophthalmic Solution Recalled for Crystalline Particulate Matter
H J Harkins Company is recalling Gentamicin Ophthalmic Solution due to crystalline particles found during clarity testing.
Product
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0421-2019·2019-02-06
Domperidone 10 mg Capsules Recalled for Lack of Processing Controls
Duren Health Mart Pharmacy is recalling 840 capsules of Domperidone 10 mg due to a lack of processing controls. The product was distributed in Tennessee.
Product
Domperidone 10 mg capsules, 100-count per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00507-2011-00
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0428-2019·2019-02-06
Mylan Recalls Fexofenadine Tablets Due to Elevated Impurities
Mylan Pharmaceuticals is recalling specific lots of Fexofenadine HCl 180 mg tablets because routine stability testing showed slightly elevated related compounds.
Product
Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0420-2019·2019-02-06
Progesterone 100 mg SR Capsules Recalled for Lack of Processing Controls
Duren Health Mart Pharmacy is recalling 1,306 capsules of Progesterone 100 mg SR due to a lack of processing controls.
Product
Progesterone 100 mg SR capsules, 30-180 capsules per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00311-2003-01
Category
Drug
Distribution
1 state
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-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
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-0389-2019·2019-01-30
Dr. Reddy's Recalls Ezetimibe and Simvastatin Tablets Due to Foreign Substance
Dr. Reddy's is recalling specific bottles of Ezetimibe and Simvastatin tablets because black speckles were observed on the tablets.
Product
Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind. Ltd. Jerusalem, 9777402, Israel; Distributed by: Dr. Reddy's Laboratories Inc. Princeton, NJ 08540 USA, NDC 43598-586-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0385-2019·2019-01-30
Bound Tree Medical Recalls Curaplex Epi Safe Training Kits Due to Labeling Errors
Bound Tree Medical is recalling 2,654 Curaplex Epi Safe training kits because the instructions recommend an unapproved epinephrine dosage for young children.
Product
Curaplex Epi Safe Kit, 8600-01102 TRAINING ONLY, Rx Only, Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc. 5000 Tuttle Crossing Blvd. Dublin, OH 43016
Category
Medical Device
Distribution
Distributed nationwide

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8751–8775 of 17974