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

16801–16825 of 18042

ModerateFDA (Drugs)·D-917-2013·2013-09-04
Actavis Recalls Bupropion Hydrochloride Extended-Release Tablets for Dissolution Failures
Actavis South Atlantic LLC is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets (XL) 300 mg because they failed to meet dissolution specifications.
Product
buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-924-2013·2013-09-04
Teva Recalls Propranolol Hydrochloride Tablets Due to Weight Specification Failures
Teva Pharmaceuticals is recalling specific lots of Propranolol Hydrochloride 10 mg tablets because some may not meet weight specifications.
Product
Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, Manufactured in Czech Republic by: Teva Czech Industries, sro, Opava komanov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-467-03
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-915-2013·2013-08-28
Fresenius Kabi Recalls Irinotecan Hydrochloride Injection Due to Crystallization
Fresenius Kabi USA LLC is recalling 23,672 vials of Irinotecan Hydrochloride Injection because the active ingredient is precipitating in the solution.
Product
IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-912-2013·2013-08-28
Wise Woman Herbals Eyebright Eye Rinse Recalled for Sterility Concerns
Wise Woman Herbals is recalling Eyebright Concentrate Topical Eye Rinse because it was not manufactured under sterile conditions required for ophthalmic products.
Product
Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and distributed by: Wise Woman Herbals, Creswell, OR
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-913-2013·2013-08-28
VistaPharm Recalls Nystatin Oral Suspension Due to Impurity Test Failures
VistaPharm is recalling Nystatin Oral Suspension because it failed impurity and degradation specifications. The affected product is distributed nationwide.
Product
Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-898-2013·2013-08-28
Stayma Recalls Duet DHA 430 Vitamins for Subpotent Beta Carotene
Stayma Consulting Service is recalling Duet DHA 430 vitamin and Omega-3 products because the beta carotene (Vitamin A) content is subpotent.
Product
Duet DHA 430, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Manufactured for W.H. Nutritionals, Wilmington, DE --- NDC 76331-808-30
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-894-2013·2013-08-28
Duet DHA Balanced Recalled for Subpotent Beta Carotene Content
Stayma Consulting Service is recalling Duet DHA Balanced tablets and softgels because the beta carotene (Vitamin A) content is subpotent.
Product
Duet DHA Balanced, 1) 30 count tablet blister cards and 5 count softgels blister cards combination pack (NDC 44118-775-30 and NDC 44118-800-30) 2) physician samples (carton contain 7 envelopes each with one 5 count tablet blister card and 5 softgels (NDC 44118-800-05) Rx only…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-916-2013·2013-08-28
Medicis Recalls CLENZIderm Pore Therapy Due to CLENZIderm Cleanser Mislabeling
Medicis Pharmaceutical Corp is recalling CLENZIderm M.D. Pore Therapy kits because some bottles were incorrectly filled with Daily Foam Cleanser. The recall covers specific lots distributed in the US and internationally.
Product
CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit, Distributed by OMP, Inc., Long Beach, CA 90806, Kit is comprised of: Daily Care Foaming Cleanser (Salicylic Acid 2%) NDC 62032-111; Pore Therapy (Salicylic Acid 2%) NDC 62032-110 and Therapeutic Lotion (Benzoyl…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-897-2013·2013-08-28
Stayma Recalls Subpotent NataChew Multi-Vitamin Tablets
Stayma Consulting Service is recalling specific lots of NataChew multi-vitamin tablets because they contain subpotent levels of beta carotene (Vitamin A).
Product
NataChew, 1) one 90-count bottle of multi-vitamin tablets (imprinted 902), (NDC 44118-902-90) and 2) physician samples containing nine bottles with 5 multi-vitamin tablets (imprinted 902) (NDC 44118-902-05), Manufactured for Eckson Labs, Wilmington, DE
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-899-2013·2013-08-28
Duet DHA 430 ec Recalled for Subpotent Beta Carotene
Stayma Consulting Service is recalling Duet DHA 430 ec because the beta carotene (Vitamin A) content is subpotent.
Product
Duet DHA 430 ec, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-810-30)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-914-2013·2013-08-28
Bracco Recalls Tagitol V Barium Sulfate Suspension Due to Stability Failure
Bracco Diagnostics Inc is recalling Tagitol V Barium Sulfate Suspension Lot #65846 because samples failed viscosity specifications.
Product
Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc. Lake Success, NY 11042 Tel: 1-516-333-8230 1-800-544-4624 NDC 32909-814-53
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-911-2013·2013-08-28
Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit Recalled for Defective Bottle
Braintree Laboratories is recalling 10,362 cartons of HalfLytely and Bisacodyl Tablet Bowel Prep Kits due to micro-fractures in the 2-liter bottle that cause leaks.
Product
Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) NDC 52268-523-02
Category
Drug
Distribution
0 states
LowFDA (Drugs)·D-903-2013·2013-08-28
Novartis Recalls Maalox Antacid Tablets Due to Illegible Packaging Labels
Novartis Consumer Health is recalling Maalox Regular Strength Antacid chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle packaging.
Product
Maalox Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wild Berry flavor, packaged in a) 50-count (UPC 0 58478 44825 1), b) 100-count (UPC 0 58478 44826 8) and c) 145-count (UPC 0 58478 44836 7) tablets per bottle, Novartis Consumer Health Canada Inc.…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-910-2013·2013-08-28
Novartis Recalls Maalox Nighttime Antacid Tablets Due to Illegible Labeling
Novartis is recalling Maalox Nighttime Antacid chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle packaging.
Product
Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Cherry flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-905-2013·2013-08-28
Novartis Recalls Maalox Antacid Tablets Due to Illegible Labeling
Novartis is recalling Maalox Advanced Maximum Strength Antacid & Antigas chewable tablets because the lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Product
Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, packaged in a) 35-count (NDC 0067-6279-35) (UPC 3 0067-0343-35 4); b) 65-count (NDC 0067-6279-65) (UPC 3 0067-0343-65 1); and c)…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-896-2013·2013-08-28
Stayma Recalls Duet DHA 400 ec Due to Subpotent Beta Carotene
Stayma Consulting Service is recalling specific lots of Duet DHA 400 ec because the beta carotene (Vitamin A) content is subpotent.
Product
Duet DHA 400 ec, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Rx only, Manufactured for Eckson Labs, Wilmington, DE (NDC 44118-809-30) and Manufactured for W.H. Nutritionals, Wilmington, DE (NDC…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-909-2013·2013-08-28
Novartis Recalls Maalox Nighttime Antacid Due to Illegible Packaging Labels
Novartis Consumer Health is recalling Maalox Nighttime Antacid chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle packaging.
Product
Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Mint flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-906-2013·2013-08-28
Novartis Recalls Maalox Extra Strength Antacid Tablets Due to Illegible Labeling
Novartis is recalling Maalox Extra Strength Antacid chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle packaging.
Product
Maalox Extra Strength Antacid (calcium carbonate) chewable tablets,1000 mg, Wild Berry flavor, packaged in a) 35-count (UPC 0 58478 44829 9) and b) 65-count (UPC 0 58478 44842 8) tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-908-2013·2013-08-28
Novartis Recalls Maalox Extra Strength Antacid Due to Illegible Labeling
Novartis is recalling Maalox Extra Strength Antacid chewable tablets because the lot number or expiration date may be illegible on the packaging.
Product
Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 600 mg/60 mg, Wild Berry flavor, 35-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-895-2013·2013-08-28
FDA Recalls Duet DHA 400 for Subpotent Beta Carotene
Stayma Consulting Service is recalling Duet DHA 400 multi-vitamin and Omega-3 products because they contain subpotent levels of beta carotene (Vitamin A).
Product
Duet DHA 400, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Rx only, Manufactured for Eckson Labs, Wilmington, DE (NDC 44118-807-30) --- Also Manufactured for W.H. Nutritionals, Wilmington, DE (NDC…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-902-2013·2013-08-28
Novartis Recalls Maalox Extra Strength Antacid Tablets Due to Illegible Labeling
Novartis is recalling Maalox Extra Strength Antacid with Anti-Gas chewable tablets because the lot number and expiration date may be illegible on the packaging.
Product
Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-904-2013·2013-08-28
Novartis Recalls Maalox Antacid Tablets Due to Illegible Packaging Labels
Novartis Consumer Health is recalling Maalox Advanced Maximum Strength Antacid & Antigas chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle.
Product
Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Wild Berry flavor, 65-count tablets per bottle, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-62791-65, UPC 3…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-907-2013·2013-08-28
Novartis Recalls Maalox Antacid Tablets Due to Illegible Labeling
Novartis Consumer Health is recalling Maalox Regular Strength Antacid chewable tablets because the lot number and expiration date may be illegible on the packaging.
Product
Maalox, Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wintergreen flavor, 50-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 02238290, UPC 0 58478 44824 4.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-900-2013·2013-08-28
Stayma Recalls Subpotent Nata Komplete Multi-Vitamin Tablets
Stayma Consulting Service is recalling specific lots of Nata Komplete multi-vitamin tablets because they contain subpotent levels of beta carotene (Vitamin A).
Product
Nata Komplete, containing one 30-count bottle of multi-vitamin tablets (imprinted 909), Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-909-30) and physician samples of nine bottles of 5-multi-vitamin tablets (NDC 76331-909-05 )
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-901-2013·2013-08-28
AbbVie Recalls Mavik Trandolapril Tablets Due to Outdated Package Insert
AbbVie is recalling 704 bottles of Mavik trandolapril tablets 4mg because they were packaged with an outdated version of the package insert.
Product
Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for Abbott Laboratories, North Chicago, IL 60064, USA
Category
Drug
Distribution
Distributed nationwide

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16801–16825 of 18042