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

7976–8000 of 18015

ModerateFDA (Drugs)·D-1317-2019·2019-06-05
Inopak Recalls Sani-Guard-SF Foam Hand Sanitizer Due to Manufacturing Deviations
Inopak Ltd is recalling Sani-Guard-SF Waterless Foam Hand Sanitizer because it was not produced under current good manufacturing practices.
Product
Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches per case, 5068-FL1000, b) 1000 ml cartridge pouch, 6/1000 ml .8ml Option Cartridge pouches per case, 5068-OS1000, Inopak LTD
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1319-2019·2019-06-05
Inopak Recalls Unison Hand Cleaner for Manufacturing Practice Violations
Inopak Ltd is recalling Unison Hand Care Products due to production not meeting current good manufacturing practices.
Product
Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with Triclosan, #4302, with exclusive Bajan fragrance, packaged in 800 ML (27 FL OZ) pouch containers, 12-800 ml containers/12-27 FL. OZ. container pouches per case, National Chemical Laboratories, Inc., 401 N
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1310-2019·2019-06-05
Inopak Recalls Antibacterial Foaming Hand Wash for CGMP Deviations
Inopak Ltd is recalling specific batches of Antibacterial Foaming Hand Wash because they were not produced under current good manufacturing practices.
Product
ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.M.X, packaged in a) 18 oz bottles, 12/18 oz bottles per case, 5063-432-02; b) 1 gallon bottles, 4/1 gallon bottles per case, 5063-420-03; c) Options Systems Antibacterial Foaming H
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1314-2019·2019-06-05
Inopak Recalls INOFOAM Food Handling Wash for CGMP Deviations
Inopak Ltd is recalling INOFOAM Foaming E-2 Food Handling Wash because it was not produced under current good manufacturing practices.
Product
INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-110-11), 6/1000 ML pouches per case (NDC 058575-110-80), 5064-FL1000, Inopak, LTD.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1313-2019·2019-06-05
Inopak Recalls Inoderm Antiseptic Hand Soap Due to Manufacturing Deviations
Inopak Ltd is recalling Inoderm Antiseptic Hand Soap because it was not produced under current good manufacturing practices.
Product
INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) PCMX, 800ml/27fl.oz.pouches (NDC 058575-110), 12 x 800 Bag-N-Box pouches per case (NDC 058575-110-80), 5014-404-NB; INOPAK, 24 Executive PKWY, Ringwood, NJ 07456.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1311-2019·2019-06-05
Inopak Recalls AQUACIL Hand Sanitizer Due to Manufacturing Deviations
Inopak Ltd is recalling specific batches of AQUACIL instant foaming hand sanitizer because they were not produced under current good manufacturing practices.
Product
AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1% (w/w), packaged in a) 18 FL OZ (532 mL) bottles, 12/18OZ bottles per case, Product Code BIO-5075-432-02; b) 1000 ML pouches, 6/1000 ML pouches per case, Product Code BIO575-OS1000, Biocentris
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1309-2019·2019-05-29
Novartis Recalls Promacta Oral Suspension Due to Peanut Cross-Contamination
Novartis is recalling Promacta (eltrombopag olamine) 12.5 mg oral suspension due to possible cross-contamination with peanut flour.
Product
PROMACTA — PROMACTA (ELTROMBOPAG OLAMINE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1286-2019·2019-05-29
Losartan Potassium Tablets Recalled Due to Impurity Presence
Golden State Medical Supply is recalling Losartan Potassium Tablets because FDA labs found an impurity above acceptable levels.
Product
Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 Rx only GSMS Incorporated
Category
Drug
Distribution
6 states
SevereFDA (Drugs)·D-1284-2019·2019-05-29
Losartan Potassium Tablets Recalled Due to Impurity Presence
Golden State Medical Supply Inc. is recalling Losartan Potassium Tablets 25 mg because FDA testing found an impurity above acceptable levels.
Product
Losartan Potassium Tablets USP 25 mg 1000 count bottle NDC 60429-316-10 Rx only GSMS Incorporated
Category
Drug
Distribution
6 states
SevereFDA (Drugs)·D-1291-2019·2019-05-29
Heritage Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity
Heritage Pharmaceuticals is recalling Losartan Potassium Tablets 25 mg because FDA labs found an impurity above acceptable levels.
Product
Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceutical
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1289-2019·2019-05-29
Heritage Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity
Heritage Pharmaceuticals is recalling Losartan Potassium Tablets 50 mg because FDA testing found an impurity above acceptable levels.
Product
Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc.,
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1283-2019·2019-05-29
Losartan Potassium Tablets Recalled Due to Impurity Presence
Golden State Medical Supply Inc. is recalling Losartan Potassium Tablets 25 mg because FDA labs found an impurity above acceptable levels.
Product
Losartan Potassium Tablets USP 25 mg 90 count bottle NDC 60429-316-90 Rx only GSMS Incorporated
Category
Drug
Distribution
6 states
SevereFDA (Drugs)·D-1287-2019·2019-05-29
Heritage Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity
Heritage Pharmaceuticals is recalling Losartan Potassium Tablets 50 mg because FDA labs found an impurity above acceptable levels.
Product
Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceutica
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1285-2019·2019-05-29
Losartan Potassium Tablets Recalled Due to Impurity Presence
Golden State Medical Supply Inc. is recalling Losartan Potassium Tablets 100 mg because FDA labs found an impurity above acceptable levels.
Product
Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx only GSMS Incorporated
Category
Drug
Distribution
6 states
SevereFDA (Drugs)·D-1288-2019·2019-05-29
Heritage Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity
Heritage Pharmaceuticals is recalling Losartan Potassium Tablets 100 mg because FDA labs found an impurity above acceptable levels.
Product
Losartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc.,
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1290-2019·2019-05-29
Heritage Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity
Heritage Pharmaceuticals is recalling Losartan Potassium Tablets 100 mg because FDA labs found an impurity above acceptable levels.
Product
Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceut
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1282-2019·2019-05-29
Losartan Potassium Tablets Recalled Due to Impurity Presence
Golden State Medical Supply Inc. is recalling Losartan Potassium Tablets 25 mg because FDA labs confirmed an impurity above acceptable levels.
Product
Losartan Potassium Tablets USP 25 mg 30 count bottle NDC 60429-316-30 Rx only GSMS Incorporated
Category
Drug
Distribution
6 states
ModerateFDA (Drugs)·D-1307-2019·2019-05-29
Septodont Recalls Articadent Dental Cartridges Due to Carton Mislabeling
Septodont Inc. is recalling 240 cartons of Articadent dental cartridges because the printed cartons contained text for both Articadent and Xylocaine, though the cartridges themselves are correctly labeled.
Product
ARTICADENT — ARTICADENT (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1295-2019·2019-05-29
Amitiza Capsules Recalled Due to Labeling Mix-Up Between Strengths
Mallinckrodt Pharmaceuticals is recalling Amitiza capsules because 24 mcg capsules were found in 8 mcg bottles and vice versa.
Product
AMITIZA — AMITIZA (LUBIPROSTONE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1294-2019·2019-05-29
Mallinckrodt Recalls Amitiza Capsules Due to Labeling Mix-Up
Mallinckrodt Pharmaceuticals is recalling Amitiza (lubiprostone) capsules because 8 mcg and 24 mcg bottles were found with incorrect contents.
Product
AMITIZA — AMITIZA (LUBIPROSTONE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1292-2019·2019-05-22
Titanium 4000 capsules recalled for undeclared sildenafil and tadalafil
D.B.P. Distribution is recalling Titanium 4000 capsules because they contain undeclared sildenafil and tadalafil and were marketed without an approved NDA or ANDA.
Product
Titanium 4000, capsule, 4000 mg, 1 count blister card, 30 blister display boxt, distributed by Titanium 4000 UPC 86077000020
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1281-2019·2019-05-22
Preferred Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity
Preferred Pharmaceuticals is recalling Losartan Potassium 50mg tablets because FDA testing found an impurity above acceptable levels.
Product
Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA, Mfg: Torrent Pharma Inc., Basking Ridge, NJ
Category
Drug
Distribution
3 states
ModerateFDA (Drugs)·D-1301-2019·2019-05-22
DrKids Children's Cough Syrup Recalled for Potential B. cepacia Contamination
Unipharma is recalling DrKids Children's Cough & Chest Congestion DM due to potential contamination with B. cepacia bacteria.
Product
DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guaifenesin 100 mg Mixed Berry Flavor 20 Pre-measured Singe-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-013-20, UPC 370302268010
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1304-2019·2019-05-22
CVS Health Children's Nasal Saline Drops Recalled for B. cepacia Risk
Unipharma, LLC is recalling CVS Health Children's Nasal Saline Drops due to potential contamination with B. cepacia bacteria.
Product
CVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moisturizer Single-Use 30 Single-Use 0.05 fl. oz. (1.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1306-2019·2019-05-22
CVS Children's Cough Syrup Recalled for Potential B. cepacia Contamination
Unipharma is recalling CVS Health Children's Cough & Chest Congestion DM due to potential contamination with B. cepacia bacteria.
Product
CVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant Mixed Berry Flavor 20 Single-Use Vials 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895,NDC 69842-262-01,
Category
Drug
Distribution
Distributed nationwide

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7976–8000 of 18015