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

8226–8250 of 18015

ModerateFDA (Drugs)·D-1057-2019·2019-04-03
Lupin Recalls Fayosim Tablets Due to Impurity Test Failures
Lupin Pharmaceuticals is recalling specific lots of Fayosim tablets because they failed impurity specifications during stability testing.
Product
Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and ethinyl estradiol tablets USP, (0.01 mg), packaged in 1 Extended-Cycle Wallet of 91 Tablets packed in a pouch(NDC 68180-860-11); one pouch per carton (NDC 68180-86
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1056-2019·2019-04-03
Allergan Recalls 72 Bottles of Combigan Eye Drops for cGMP Deviations
Allergan is voluntarily recalling 72 bottles of Combigan ophthalmic solution in Tennessee due to current Good Manufacturing Practice (cGMP) deviations.
Product
COMBIGAN — COMBIGAN (BRIMONIDINE TARTRATE, TIMOLOL MALEATE)
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-1061-2019·2019-04-03
Ecolab Recalls Advanced Gel Hand Sanitizer Due to Chemical Contamination
Ecolab is recalling Advanced Gel Hand Sanitizer because low levels of substituted benzene compounds were found after complaints of malodor.
Product
ADVANCED GEL HAND SANITIZER — ADVANCED GEL HAND SANITIZER (ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1058-2019·2019-04-03
Ingenus Recalls Diclofenac Sodium Topical Solution Due to Leaking Bottles
Ingenus Pharmaceuticals is recalling 29,435 bottles of Diclofenac Sodium Topical Solution because some bottles were found leaking.
Product
Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1038-2019·2019-03-27
Aurobindo Recalls Valsartan Tablets Due to NDEA Impurity
Aurobindo Pharma USA is recalling specific lots of Valsartan 80 mg tablets because FDA analysis confirmed trace amounts of the impurity N-nitrosodiethylamine (NDEA).
Product
VALSARTAN — VALSARTAN (VALSARTAN)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1045-2019·2019-03-27
AvKARE Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity
AvKARE Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets because an impurity, N-Methylnitrosobutyric acid (NMBA), was identified.
Product
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1047-2019·2019-03-27
Valsartan Tablets Recalled Due to Carcinogenic Impurity
American Health Packaging is recalling Valsartan Tablets 160 mg because a carcinogenic impurity was detected in the active ingredient.
Product
Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 (Individual Dose NDC:60687-139-11, Carton NDC#: 60687-139-01)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1030-2019·2019-03-27
Advanced Pharma Recalls Heparin Syringes Due to Sterility Concerns
Advanced Pharma Inc. is recalling 500 syringes of Heparin 10 Units/10 mL due to a lack of assurance of sterility. The product was distributed nationwide.
Product
Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectable Solution, Dwell, 10mL Sterile single use syringe, NDC: 42852-725-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1044-2019·2019-03-27
AvKARE Recalls Losartan Potassium Tablets Due to Impurity
AvKARE Inc. is recalling Losartan Potassium Tablets 50 mg because an impurity, N-Methylnitrosobutyric acid (NMBA), was identified.
Product
Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC 50268-517-15
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1050-2019·2019-03-27
Losartan Potassium Tablets Recalled Due to Impurity Detection
Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, 100 mg, due to the presence of the impurity N-Methylnitrosobutyric acid (NMBA).
Product
Losartan Potassium Tablets, USP, 100 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045. NDC 68645-579-54
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-1051-2019·2019-03-27
Preferred Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity
Preferred Pharmaceuticals is recalling Losartan Potassium 50 mg tablets because an impurity, N-Methylnitrosobutyric acid (NMBA), was identified.
Product
Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC: 68788-0048-09), Rx Only, Mfg: Torrent Pharma Inc. Basking Ridge, NJ. Relabeled by: Preferred Pharmaceuticals, Inc. 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807.
Category
Drug
Distribution
3 states
SevereFDA (Drugs)·D-1035-2019·2019-03-27
Aurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity
Aurobindo Pharma USA Inc. is recalling specific lots of Valsartan Tablets USP 320 mg because FDA analysis confirmed the presence of trace amounts of the impurity N-nitrosodiethylamine (NDEA).
Product
VALSARTAN — VALSARTAN (VALSARTAN)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1017-2019·2019-03-27
Advanced Pharma Recalls Fentanyl Injectable Solution Due to Sterility Concerns
Advanced Pharma Inc. is recalling 360 bags of fentanyl injectable solution nationwide due to a lack of assurance of sterility.
Product
fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, QS, 100 mL, Sterile single use bag, NDC: 42852-210-10 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1028-2019·2019-03-27
Advanced Pharma Recalls Phenylephrine HCl Injectable Syringes for Sterility Concerns
Advanced Pharma Inc. is recalling 800 syringes of Phenylephrine HCl Injectable Solution due to a lack of assurance of sterility. The product was distributed nationwide.
Product
Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution, 800 mcg/10 mL (80 mcg per mL), 10mL Sterile single use syringe, NDC: 42852-865-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1033-2019·2019-03-27
Advanced Pharma Recalls Morphine Sulfate Syringes Due to Sterility Concerns
Advanced Pharma Inc. is recalling 2,325 syringes of Morphine Sulfate 30 mg/30 mL Injectable Solution nationwide due to a lack of assurance of sterility.
Product
Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 30 mg 0.9% Sodium Chloride QS 30 mL Sterile singe use syringe, NDC: 42852-241-63 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1031-2019·2019-03-27
Advanced Pharma Recalls Heparin Syringes Due to Sterility Concerns
Advanced Pharma Inc. is recalling 1,440 syringes of Heparin 5,000 Units/5mL Injectable Solution nationwide due to a lack of assurance of sterility.
Product
Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in 0.9% Sodium Chloride, QS 5 mL Sterile single use syringe, NDC: 42852-739-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1025-2019·2019-03-27
Advanced Pharma Recalls Glycopyrrolate Injectable Syringes Due to Sterility Concerns
Advanced Pharma Inc. is recalling 140 syringes of Glycopyrrolate 0.6 mg/3 mL Injectable Solution because the company cannot ensure the product is sterile.
Product
Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile single use syringe, For IV or IM use, NDC: 42852-828-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1037-2019·2019-03-27
Aurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity
Aurobindo Pharma USA Inc. is recalling specific lots of Valsartan 40 mg tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).
Product
VALSARTAN — VALSARTAN (VALSARTAN)
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1023-2019·2019-03-27
Advanced Pharma Recalls Phenylephrine Syringes Due to Sterility Concerns
Advanced Pharma Inc. is recalling 22,900 syringes of Phenylephrine HCl injectable solution nationwide due to a lack of assurance of sterility.
Product
Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1 mg/10 mL (100 mcg per mL), Sterile single use syringe, NDC: 42852-830-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1048-2019·2019-03-27
Losartan Potassium Tablets Recalled Due to Impurity Detection
Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, 25 mg, because an impurity was detected. The recall involves 456,732 bottles distributed by Wal-Mart.
Product
Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-577-54
Category
Drug
Distribution
5 states
SevereFDA (Drugs)·D-1016-2019·2019-03-27
Advanced Pharma Recalls Hydromorphone Syringes Due to Sterility Concerns
Advanced Pharma Inc. is recalling 2,400 syringes of Hydromorphone HCl injectable solution nationwide due to a lack of assurance of sterility.
Product
HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-289-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1041-2019·2019-03-27
Camber Pharmaceuticals Recalls Losartan Potassium Tablets Due to NMBA Contamination
Camber Pharmaceuticals is recalling Losartan Potassium tablets because trace amounts of the nitrosamine NMBA were detected in the active ingredient.
Product
LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1008-2019·2019-03-27
FDA Recalls Volumex Iodinated I-131 Albumin Due to Sterility Concerns
Iso-Tex Diagnostics is recalling 54 syringes of Volumex (Iodinated I-131 Albumin) because environmental monitoring results exceeded limits, meaning sterility cannot be assured.
Product
VOLUMEX — VOLUMEX (IODINATED I-131 ALBUMIN)
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1022-2019·2019-03-27
Advanced Pharma Recalls Phenylephrine Syringes Due to Sterility Concerns
Advanced Pharma Inc. is recalling 1,575 syringes of Phenylephrine HCl injectable solution because the company cannot guarantee the product is sterile.
Product
Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 400 mcg/10 mL (40 mcg per mL), Sterile single use syringe, NDC: 42852-876-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1039-2019·2019-03-27
Aurobindo Recalls Valsartan Tablets Due to NDEA Impurity
Aurobindo Pharma USA is recalling Valsartan tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA) in the active ingredient.
Product
VALSARTAN — VALSARTAN (VALSARTAN)
Category
Drug
Distribution
0 states

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8226–8250 of 18015