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

8901–8925 of 17974

SevereFDA (Drugs)·D-0268-2019·2018-11-28
Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity
Sciegen Pharmaceuticals is recalling Irbesartan Tablets, 150 mg, because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).
Product
Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-120-01), (b) 90-count bottle (NDC 69367-120-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755, Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854, Made i
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0265-2019·2018-11-28
Golden State Medical Supply Recalls Irbesartan Tablets Due to Impurity
Golden State Medical Supply is recalling 12,502 bottles of Irbesartan 300 mg tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA).
Product
IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90) Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0264-2019·2018-11-28
Golden State Medical Supply Recalls Irbesartan Tablets Due to Impurity
Golden State Medical Supply is recalling Irbesartan 150 mg tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA).
Product
IRBESARTAN Tablets, USP 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90) Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0272-2019·2018-11-28
Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity
Sciegen Pharmaceuticals is recalling GSMS Irbesartan Tablets, USP, 300 mg, because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).
Product
GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0270-2019·2018-11-28
Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity
Sciegen Pharmaceuticals is recalling GSMS Irbesartan Tablets, 75 mg, because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).
Product
GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Marketed by: GSMS Incorporated Camarillo, CA 93012 USA, NDC 60429-640-90.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0266-2019·2018-11-28
L. Perrigo Recalls Calcium Carbonate Antacid Tablets Due to Metal Particles
L. Perrigo is recalling specific lots of calcium carbonate antacid tablets because they were found to contain metal particles.
Product
Antacid Tablets, Calcium Carbonate chewable tablets, 750mg, 60-count bottle, OTC, [Healthy Accents brand NDC: 55316-014-72, Distributed by DZA Brands, LLC, Salisbury, NC 28147, Scarborough, ME 04074], [HealthMart Pharmacy brand NDC: 62011-0295-1, Distributed by McKessen, One Post
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0283-2019·2018-11-28
Dr. Reddy's Recalls Clopidogrel Tablets Due to Dissolution Failure
Dr. Reddy's Laboratories is recalling specific lots of Clopidogrel Bisulfate tablets because they failed dissolution testing during stability checks.
Product
CLOPIDOGREL BISULFATE — CLOPIDOGREL BISULFATE (CLOPIDOGREL BISULFATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0274-2019·2018-11-28
Ecolab Equi-Soft Foam Antimicrobial Hand Soap Recalled for Labeling Error
Ecolab is recalling Equi-Soft Foam Antimicrobial Hand Soap because the label may not match the formula in the bottle.
Product
ECOLAB — ECOLAB (BENZALKONIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0275-2019·2018-11-28
Ecolab Recalls Medi-Stat Foam Hand Soap Due to Labeling Error
Ecolab Inc is recalling 14,108 bottles of Medi-Stat Foam Antimicrobial Hand Soap because the label may not match the formula in the bottle.
Product
Medi-Stat Foam, Antimicrobial Hand Soap, Chloroxylenol 0.5%, 1250 mL (42.3 fl oz), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102, NDC 47593-503-59
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0273-2019·2018-11-28
Nitrofurantoin Capsules Recalled for Potential Cross-Contamination with Unrelated Ingredients
American Health Packaging is recalling specific lots of Nitrofurantoin Capsules due to potential cross-contamination with unrelated active ingredients.
Product
Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters, Rx only, Amerisource Health Services DBA American Health Packaging, 2550-A John Glenn Avenue Columbus, OH 43217, NDC 68084-446-01 (Individual Dose NDC: 68064-446-11)
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-0288-2019·2018-11-21
Euphoric Male Performance Enhancer Recalled for Undeclared Prescription Drugs
Epic Products, LLC is recalling Euphoric Premium Male Performance Enhancer capsules because they contain undeclared sildenafil, tadalafil, and oxytetracycline.
Product
Euphoric Premium Male Performance Enhancer capsules, packaged in a)1-count blister cards, UPC 6 96859 28646 9, b) 3-count bottle, UPC 6 96859 28647 6 and c) 12-count bottle, UPC 6 96859 28648 3.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0250-2019·2018-11-21
Kadesh Recalls Puriton Eye Relief Drops for Non-Sterility
Kadesh International is recalling Puriton Eye Relief Drops because they were manufactured under non-sterile production conditions.
Product
puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0260-2019·2018-11-21
Sandoz Recalls Isosorbide Dinitrate Tablets Due to Cross Contamination
Sandoz Inc. is recalling 5,100 bottles of Isosorbide Dinitrate Tablets, USP 10 mg, due to cross contamination with other products.
Product
Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-225-00
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0261-2019·2018-11-21
Sandoz Recalls Isosorbide Dinitrate Tablets Due to Cross Contamination
Sandoz Inc. is recalling 1,550 bottles of Isosorbide Dinitrate Tablets 20 mg due to cross-contamination with other products.
Product
Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-222-00
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0246-2019·2018-11-21
Zero Xtreme Dietary Supplement Recalled for Undeclared Sibutramine
Zero Xtreme USA is recalling 16 bottles of Zero Xtreme Dietary Supplement capsules because they contain undeclared sibutramine and were marketed without an approved NDA or ANDA.
Product
Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0276-2019·2018-11-21
Taro Recalls Children's Allergy Solution Due to Impurity
Taro Pharmaceuticals is recalling 12,432 bottles of Children's 24 Hour Allergy Oral Solution because an unknown impurity exceeded limits during stability testing.
Product
Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 FL OZ (120 mL) bottle, Dist. by Meijer Distribution, Inc., Grand Rapids, MI 40644, NDC 41250-106-08, UPC 7 13733 88578 2.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0259-2019·2018-11-21
Sandoz Recalls Isosorbide Dinitrate Tablets Due to Cross Contamination
Sandoz Inc. is recalling Isosorbide Dinitrate Tablets 5 mg due to cross-contamination with other products. The recall affects 7,817 bottles distributed nationwide.
Product
Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-223-00
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0244-2019·2018-11-21
Teva Recalls Alprostadil Injection Due to Impurity Testing Failures
Teva Pharmaceuticals is recalling Alprostadil Injection vials because routine stability testing revealed out-of-specification impurities.
Product
Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales, PA --- NDC 0703-1501-02
Category
Drug
Distribution
2 states
HighFDA (Drugs)·D-0258-2019·2018-11-21
Sandoz Recalls Isosorbide Dinitrate Tablets Due to Cross Contamination
Sandoz Inc. is recalling 18,832 bottles of Isosorbide Dinitrate 20 mg tablets due to cross-contamination with other products.
Product
ISOSORBIDE DINITRATE — ISOSORBIDE DINITRATE (ISOSORBIDE DINITRATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0277-2019·2018-11-21
Taro Recalls Children's Allergy Oral Solution Due to Impurity
Taro Pharmaceuticals is recalling 8,328 bottles of Children's Allergy (cetirizine hydrochloride) oral solution because an unknown impurity exceeded specified limits during stability testing.
Product
CHILDRENS ALLERGY — CHILDRENS ALLERGY (CETIRIZINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0278-2019·2018-11-21
Taro Recalls Children's Allergy Relief Oral Solution Due to Impurity
Taro Pharmaceuticals is recalling specific bottles of children's allergy relief oral solution because an unknown impurity exceeded safety limits during routine testing.
Product
children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ (120 mL) bottle, Distributed by Rite-Aid, 30 Hunter Lane, Camp Hill, PA 17011, Made in Israel, UPC 0 11822 57363 4.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0257-2019·2018-11-21
Sandoz Recalls Nitrofurantoin Capsules Due to Cross Contamination
Sandoz Inc is recalling specific lots of Nitrofurantoin capsules because they may be cross-contaminated with other products.
Product
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) — NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) (NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS))
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0242-2019·2018-11-21
Right Value Drug Stores Recalls Tadalafil SR 7 mg Capsules for Misbranding
Right Value Drug Stores, Inc. is recalling Tadalafil SR 7 mg capsules due to misbranding. The affected lots were distributed in California.
Product
Tadalafil SR 7 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054. NDC 99999-9970-88
Category
Drug
Distribution
1 state
LowFDA (Drugs)·D-0279-2019·2018-11-21
Breckenridge Recalls Megestrol Acetate Oral Suspension for Stability Failures
Breckenridge Pharmaceutical is recalling Megestrol Acetate Oral Suspension due to out-of-specification particle size results during stability testing.
Product
Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487, Manufactured by: Pharmaceutics International Inc. Hunt Valley, MD 21031
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0248-2019·2018-11-21
Eli Lilly Recalls ERBITUX Vials Due to Missing Primary Container Labels
Eli Lilly is recalling 9,380 vials of ERBITUX (cetuximab) because some may be missing primary container labels. The recall covers specific states and Puerto Rico.
Product
ERBITUX — ERBITUX (CETUXIMAB)
Category
Drug
Distribution
11 states

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8901–8925 of 17974