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 the agency’s own highest classification or reported deaths or serious injuries, 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

15301–15325 of 18042

ModerateFDA (Drugs)·D-1294-2014·2014-05-21
Teva Recalls Indomethacin Capsules Due to Manufacturing Quality Deviations
Teva Pharmaceuticals USA is recalling 7,694 bottles of Indomethacin Capsules USP, 25 mg, due to CGMP deviations and laboratory testing failures.
Product
INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1295-2014·2014-05-21
Teva Recalls Indomethacin Capsules Due to Manufacturing Quality Deviations
Teva Pharmaceuticals USA is recalling Indomethacin Capsules USP, 50 mg, because laboratory testing was not conducted in accordance with Good Manufacturing Practice (GMP) requirements.
Product
INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1293-2014·2014-05-21
Teva Recalls Glyburide and Metformin Tablets Due to GMP Deviations
Teva Pharmaceuticals USA is recalling specific bottles of Glyburide and Metformin Hydrochloride tablets due to laboratory testing deviations from GMP requirements.
Product
GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC: 0093-5712-05
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1315-2014·2014-05-21
Konsyl Psyllium Fiber Recalled for Inaccurate Labeling of Active Ingredient Strength
Konsyl Pharmaceuticals is recalling 6,286 bottles of Psyllium Fiber capsules because the label lists an inaccurate strength for the active ingredient.
Product
PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Konsyl Pharmaceuticals, Inc., Easton, MD 21601. NDC: 0224-1847-10.
Category
Drug
Distribution
9 states
SevereFDA (Drugs)·D-1308-2014·2014-05-14
Mangiacotti Ginger Lime Hand Sanitizer Recalled for Bacterial Contamination
Mangiacotti is recalling Ginger Lime Hand Sanitizer Spray due to elevated counts of Serratia liquefaciens bacteria.
Product
Mangiacotti - Ginger Lime Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005351, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1306-2014·2014-05-14
Mangiacotti Clementine Hand Sanitizer Spray Recalled for Bacterial Contamination
Mangiacotti is recalling Clementine Hand Sanitizer Spray due to elevated counts of Serratia liquefaciens bacteria.
Product
Mangiacotti - Clementine Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005337, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1307-2014·2014-05-14
Mangiacotti Pomegranate Hand Sanitizer Recalled for Bacterial Contamination
Mangiacotti is recalling Pomegranate Hand Sanitizer Spray due to elevated counts of Serratia liquefaciens bacteria.
Product
Mangiacotti - Pomegranate Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005344, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1300-2014·2014-05-14
Wockhardt Recalls Metoprolol Succinate Tablets for Dissolution Failure
Wockhardt USA is recalling specific lots of Metoprolol Succinate Extended-Release Tablets because they failed dissolution testing at the nine-month time point.
Product
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1301-2014·2014-05-14
Blu Pharmaceuticals Recalls Metformin Tablets Due to Missing Inner Seals
Blu Pharmaceuticals is recalling 14,000 Metformin Hydrochloride tablets because the bottles were distributed without inner seals. The affected product was distributed in New Jersey, Utah, Illinois, and Connecticut.
Product
Metformin Hydrochloride Tablets USP 500 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134 NDC 24658-290-05
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-1302-2014·2014-05-14
Blu Pharmaceuticals Recalls Metformin Tablets Due to Missing Inner Seals
Blu Pharmaceuticals is recalling Metformin Hydrochloride 1000 mg tablets because bottles were distributed without inner seals. The affected lot was distributed in New Jersey, Utah, Illinois, and Connecticut.
Product
Metformin Hydrochloride Tablets USP 1000 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134, NDC 24658-0292-05
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-1304-2014·2014-05-14
Mangiacotti Lavender Hand Sanitizer Recalled for Bacterial Contamination
Mangiacotti is recalling Lavender Hand Sanitizer Spray due to elevated counts of Serratia liquefaciens bacteria. Consumers should stop using the product.
Product
Mangiacotti - Lavender Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005313, Active Ingredient Benzalkonium Chloride 0.1%, Dist by: Mangiacotti, Attleboro, MA 02703 .
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1303-2014·2014-05-14
Mangiacotti Lemon Verbena Hand Sanitizer Recalled for Bacterial Contamination
Mangiacotti is recalling Lemon Verbena Hand Sanitizer Spray due to elevated counts of Serratia liquefaciens bacteria.
Product
Mangiacotti - Lemon Verbena Hand Sanitizer Spray, alcohol free, 0.5 fl. Oz., 15 mL spray bottle, UPC 870678005306, Active Ingredient Benzalkonium Chloride 0.1%, Dist by: Mangiacotti, Attleboro, MA 02703.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1313-2014·2014-05-14
Boehringer Ingelheim Roxane Recalls Azathioprine Tablets Due to Incorrect Expiration Dates
Boehringer Ingelheim Roxane Inc is recalling 8,304 bottles of Azathioprine Tablets USP, 50 mg, because they were labeled with 36-month expiration dates instead of the approved 24 months.
Product
Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1309-2014·2014-05-14
Merck Recalls Liptruzet Tablets Due to Packaging Defects
Merck & Co. is recalling Liptruzet tablets because packaging defects allowed air and moisture to enter, potentially affecting product effectiveness.
Product
Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg, a) 30 count blister (NDC 66582-320-30), b) 90 count blister (NDC 66582-320-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1312-2014·2014-05-14
Merck Recalls Liptruzet Tablets Due to Defective Outer Packaging
Merck is recalling Liptruzet tablets because defective outer foil pouches may allow air and moisture to enter, potentially affecting product effectiveness.
Product
Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister (NDC 66582-323-30), b) 90 count blister (NDC 66582-323-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1311-2014·2014-05-14
Merck Recalls Liptruzet Tablets Due to Packaging Defects
Merck is recalling Liptruzet tablets because outer packaging defects allowed air and moisture to enter, potentially affecting product effectiveness.
Product
Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister (NDC 66582-322-30), b) 90 count blister (NDC 66582-322-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1314-2014·2014-05-14
Boehringer Ingelheim Roxane Recalls Mercaptopurine Tablets Due to Incorrect Expiration Dates
Boehringer Ingelheim Roxane Inc. is recalling Mercaptopurine Tablets USP because they were labeled with 36-month expiration dates instead of the approved 24 months.
Product
MERCAPTOPURINE — MERCAPTOPURINE (MERCAPTOPURINE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1310-2014·2014-05-14
Merck Recalls Liptruzet Tablets Due to Packaging Defects
Merck & Co. is recalling Liptruzet tablets because packaging defects allowed air and moisture to enter, potentially reducing product effectiveness.
Product
Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister (NDC 66582-321-30), b) 90 count blister (NDC 66582-321-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1277-2014·2014-05-07
Dietary Supplement Recalled for Undeclared Fluoxetine and Lack of Approval
Deseo Rebajar is recalling Adipotrim XT dietary supplements because FDA testing found undeclared fluoxetine and the product was marketed without an approved NDA/ANDA.
Product
Adipotrim XT, New Powerful Formula, 30 rapid release capsules per bottle, Dietary Supplement, www.adipotrim.com.
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1276-2014·2014-05-07
Baxter Recalls Dianeal Peritoneal Dialysis Solution Due to Mold Contamination
Baxter Healthcare is recalling 27,169 containers of Dianeal Low Calcium with Dextrose peritoneal dialysis solution due to reported leaks and mold contamination.
Product
DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1273-2014·2014-05-07
B. Braun Recalls TrophAmine Injection Due to Particulate Matter
B. Braun Medical Inc. is recalling TrophAmine (10% Amino Acid Injection) units due to visible particulate matter found in reserve samples.
Product
TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No. S9341-SS, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-9341-55
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-1269-2014·2014-05-07
B. Braun Recalls Cefazolin Sodium Injectable Due to Particulate Matter
B. Braun Medical Inc. is recalling Cefazolin Sodium injectable products because visible particulate matter was found in reserve sample units.
Product
CEFAZOLIN SODIUM — CEFAZOLIN SODIUM (CEFAZOLIN SODIUM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1263-2014·2014-05-07
Medisca Recalls Human Chorionic Gonadotropin Due to Labeling Error
Medisca Inc. is recalling specific lots of Human Chorionic Gonadotropin (HCG) because the labels contain erroneous potency information.
Product
Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For use and distribution in prescription compounding, manufacturing, processing or repacking only in accordance with FDA regulations and applicable law. Potency 5489.6IU/mg. Packed by Medisca, Inc.…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1266-2014·2014-05-07
B. Braun Recalls Ceftriaxone Injection Due to Particulate Matter
B. Braun Medical Inc. is recalling Ceftriaxone for Injection and Dextrose Injection due to visible particulate matter found in reserve sample units.
Product
Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog Number 3153-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1265-2014·2014-05-07
B. Braun Recalls Sodium Chloride Injection Due to Particulate Matter
B. Braun Medical Inc. is recalling 0.9% Sodium Chloride Injection USP due to visible particulate matter found in reserve sample units.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide

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15301–15325 of 18042