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

17526–17550 of 18042

LowFDA (Drugs)·D-186-2013·2013-03-13
Rite Aid Tussin Cough Syrup Recalled for Precipitate Presence
Aaron Industries is recalling Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF due to the presence of a white precipitate.
Product
Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg, 4 FL. OZ./12 PK (UPC Code: 0-11822-57307-8) and 8 FL.OZ./12 PK (UPC Code: 0-11822-57313-9), Distributed by: Rite Aid, Camp Hill, PA, 17011
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-185-2013·2013-03-13
Aaron Industries Recalls Walgreens Wal-Tussin CF Max Due to Precipitate
Aaron Industries is recalling 6,108 bottles of Walgreens Wal-Tussin CF Max because a white substance, confirmed as the active ingredient guaifenesin, was observed in some bottles.
Product
Well at Walgreens Wal-Tussin CF Max, MAXIMUM STRENGTH ADULT NON-DROWSY, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (237 mL) bottles, Distributed by: Walgreen Co, Deerfield, IL 60015 ---- NDC 0363-0229-08
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-182-2013·2013-03-13
Glenmark Recalls Montelukast Sodium Tablets Due to Chemical Contamination
Glenmark Generics Inc. is recalling Montelukast Sodium Tablets, 10 mg, due to trace levels of chemical contaminants causing off-odors.
Product
Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per bottle (NDC 68462-392-30) and b) 90-count tablets per bottle (NDC 68462-392-90), Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-189-2013·2013-03-13
VersaPharm Ethambutol Tablets Recalled for Discoloration
West-ward Pharmaceutical Corp. is recalling VersaPharm Ethambutol Tablets USP 400 mg because the tablet cores may be discolored.
Product
VERSAPHARM Ethambutol Tablets, USP,400 mg, Rx Only a)60 tablets, NDC 61748-014-06, b)90 tablets, NDC 61748-014-09, c)100 tablets, NDC 61748-014-01, d)1000 tablets, NDC 61748-014-10, e) blister pack (10s) 61748-014-11 Manufactured for: VersaPharm Incorporated Marietta, GA…
Category
Drug
Distribution
1 state
LowFDA (Drugs)·D-187-2013·2013-03-13
Aaron Industries Recalls Select Brand Cough Control CF Max Due to Precipitate
Aaron Industries Inc is recalling Select Brand Cough Control CF Max bottles due to the presence of a white precipitate, identified as the active ingredient guaifenesin.
Product
Select Brand Cough Control CF Max, Maximum Strength for MUCUS RELIEF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 4 fl.oz 12pk (NDC 15127-025-04; UPC Code: 0-15127-02535-5), Distributed by: Select Brand Distributors, Pine Bluff, AR 71603 USA.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-188-2013·2013-03-13
Aaron Industries Recalls Wal-Mart Equate Tussin CF Due to Precipitate
Aaron Industries is recalling Wal-Mart Equate Tussin CF bottles containing a white precipitate. The substance is confirmed as guaifenesin, an active ingredient.
Product
Wal-Mart Equate Tussin CF Adult Maximum Strength, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (235 mL) (NDC 49035-229-08; UPC Code: 6-81131-03884-30), Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72712.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-169-2013·2013-03-06
Hospira Recalls Furosemide Injection Vials Due to Sterility Concerns
Hospira is recalling 63,900 vials of Furosemide Injection USP because a loose crimp on the vial cap may compromise sterility.
Product
FUROSEMIDE — FUROSEMIDE (FUROSEMIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-168-2013·2013-03-06
Pacira Recalls Subpotent EXPAREL Bupivacaine Injectable Vials
Pacira Pharmaceuticals is recalling 324 vials of EXPAREL (bupivacaine liposome injectable suspension) because the product is subpotent.
Product
EXPAREL (bupivacaine liposome injectable suspension), 1.3%, 266 mg/20 mL (13.3 mg/mL) single use vials, INVESTIGATIONAL USE. For Infiltration Only. Not for any other route of administration. Manufactured by Paelra Pharmaceuticals. Inc., San Diego, California, USA
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-176-2013·2013-03-06
Hospira Recalls 0.9% Sodium Chloride Irrigation Due to Sterility Concerns
Hospira Inc. is recalling 56,854 units of 0.9% Sodium Chloride Irrigation, USP, 3000 mL, due to a potential leak from the administration port that compromises sterility.
Product
0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-174-2013·2013-03-06
West-ward Recalls Isoniazid Tablets for Failed Dissolution Specifications
West-ward Pharmaceutical Corp. is recalling Isoniazid Tablets 300 mg due to failed dissolution specifications and a 36-month stability timepoint issue.
Product
Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-30, b) 100 tablets - NDC 61748-013-01, Mfd for: VersaPharm Incorporated Marietta, GA 30065-1505, Mfd by: West - Ward Pharmaceutical Corp.., Eatontown, NJ 07724
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-172-2013·2013-03-06
Amedra Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures
Amedra Pharmaceuticals is recalling 12,948 bottles of Dextroamphetamine Sulfate Extended Release Capsules because they may not meet dissolution specifications over their shelf life.
Product
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-180-2013·2013-03-06
Dr. Reddy's Recalls Citalopram Tablets Due to Chemical Odor Complaints
Dr. Reddy's is recalling specific lots of Citalopram tablets because patients reported a strong garlic or chemical smell.
Product
Citalopram tablets USP, 40mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-344-30
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-173-2013·2013-03-06
Amedra Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures
Amedra Pharmaceuticals is recalling 10,968 bottles of Dextroamphetamine Sulfate Extended Release Capsules because they may not meet dissolution specifications over the product shelf life.
Product
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-329-09
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-170-2013·2013-03-06
West-ward Recalls Belladonna Alkaloids Tablets Due to Foreign Substance
West-ward Pharmaceutical Corp. is recalling Belladonna Alkaloids with Phenobarbital tablets because uncharacteristic black spots were found in the product.
Product
Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamine HBr, USP 0.0065 mg) with Phenobarbital (USP 16.2 mg) Tablets, packaged in a) 1000-count tablets per bottle (NDC 0143-1140-10; b) 5000-count tablets per bottle (NDC…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1008-2013·2013-03-06
Aptalis Recalls SourceCF Pediatric Multivitamin Drops Due to Shelf Life Concerns
Aptalis Pharma is recalling SourceCF Pediatric Drops because the formulation may not support the labeled shelf life. The recall covers 14,439 units distributed in the US, Italy, Canada, and Brazil.
Product
SourceCF(R) Pediatric Drops, Multivitamins with A, B, D, E and K Plus Zinc, 2 FL OZ. (60ML), NDC 66212-300-60, UPC 668212300600
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-178-2013·2013-03-06
Dr. Reddy's Recalls Citalopram Tablets Due to Chemical Odor Complaints
Dr. Reddy's is recalling 27,805 bottles of Citalopram tablets 10mg due to reports of a strong garlic or chemical smell.
Product
Citalopram tablets USP, 10mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-342-30
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-171-2013·2013-03-06
Amedra Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures
Amedra Pharmaceuticals is recalling 1,176 bottles of Dextroamphetamine Sulfate Extended Release Capsules because they may not meet dissolution specifications.
Product
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-179-2013·2013-03-06
Dr. Reddy's Recalls Citalopram Tablets Due to Chemical Odor Complaints
Dr. Reddy's is recalling 86,093 bottles of Citalopram tablets due to reports of a strong garlic or chemical smell.
Product
Citalopram tablets USP, 20mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-343-30
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-177-2013·2013-03-06
Bayer Recalls Bronkaid Dual Action Formula Due to Labeling Errors
Bayer Healthcare is recalling Bronkaid Dual Action Formula caplets because the carton label is missing a warning or Rx legend and other information.
Product
Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant, a) 24 coated caplets per blister pack, UPC 300240537879, b) 60 coated caplets per blister pack, UPC 300240537855, Bayer HealthCare LLC, Consumer Care, P.O. Box 1910…
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-175-2013·2013-03-06
Actavis Recalls BuPROPion Hydrochloride Tablets Due to Dissolution Failure
Actavis Pharmaceuticals is recalling 14,856 bottles of buPROPion Hydrochloride Extended-Release Tablets 300 mg because they failed dissolution specifications during stability testing.
Product
buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-166-2013·2013-02-27
UDL Recalls Hydrocodone and Acetaminophen Tablets Due to Potency Issues
Mylan Institutional, Inc. is recalling specific lots of Hydrocodone Bitartrate and Acetaminophen Tablets because the tablets are oversized, resulting in superpotent assays of both active ingredients.
Product
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 cards each containing 20 blistered tablets per carton, Rx only; Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, Pkg by &amp; Distributed by UDL Laboratories, Inc.…
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Drugs)·D-165-2013·2013-02-27
Dietary Supplement Slimdia Revolution Recalled for Containing Unapproved Drug Sibutramine
P & J Trading Co is recalling Slimdia Revolution capsules because they contain sibutramine, a drug removed from the U.S. market for safety reasons.
Product
SLIMDIA Revolution capsules, 30-count capsules per bottle, Yerba Naturals, 19685 Varda Ave., Buena Park, CA.
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-167-2013·2013-02-27
Crest Pro-Health Oral Rinse Recalled for Cross-Contamination
Procter & Gamble is recalling Crest Pro-Health Oral Rinse because it was mixed with another type of mouthwash.
Product
Crest PRO-HEALTH CPC Antigingivitis/Antiplaque Oral Rinse, 250 mL (8.4 fl oz),Dist. by Procter & Gamble, Cincinnati, OH 45202 NDC 37000-452-02
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-161-2013·2013-02-20
Lee Pharmaceuticals Recalls 12-Hour Sinus Nasal Spray Due to Microbial Contamination
Lee Pharmaceuticals is recalling 12-Hour Sinus Nasal Spray products due to microbial contamination identified during testing.
Product
12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 mL), labeled as a) 12 HOUR SINUS Nasal Spray, Best Choice, Proudly Distributed By: Valu Merchandisers, Co., Kansas City, MO 64111, UPC 0 70038 61226 1; b) Nasal Spray Sinus, Distributed by Discount Drug…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-159-2013·2013-02-20
Hospira Recalls Propofol Injectable Emulsion Due to Particulate Matter
Hospira Inc. is recalling 273,925 vials of Propofol Injectable Emulsion because visible particulate matter was found during inspection.
Product
PROPOFOL — PROPOFOL (PROPOFOL)
Category
Drug
Distribution
Distributed nationwide

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17526–17550 of 18042