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

7826–7850 of 17974

SevereFDA (Drugs)·D-1363-2019·2019-06-19
Torrent Pharma Recalls Guaifenesin AC Cough Syrup Due to Bacterial Contamination
Torrent Pharma Inc. is recalling specific lots of Guaifenesin AC Cough Syrup due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 16571-302-16, Distributed by Rising Pharmaceuticals Inc., Saddle Brook, NJ 07663
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1369-2019·2019-06-19
Torrent Pharma Recalls Extra Action Cough Syrup Due to Bacterial Contamination
Torrent Pharma Inc is recalling Extra Action Cough Syrup due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/10 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0970-97, b) One Pint (473 mL) bottle, 0536-0970-85, Distributed by Rugby Laboratories, Livonia, MI 48152.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1338-2019·2019-06-19
Pharm D Solutions Recalls Testosterone Cypionate Vials for Sterility Concerns
Pharm D Solutions is recalling specific lots of Testosterone Cypionate 200 mg/mL vials due to a lack of sterility assurance.
Product
Testosterone Cypionate 200 mg/mL, in a) 5mL vials and b)10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1702-10
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1381-2019·2019-06-19
Torrent Pharma Recalls Cetirizine Hydrochloride Oral Solution Due to Contamination
Torrent Pharma Inc. is recalling specific lots of Cetirizine Hydrochloride Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only, Rx only, 120 mL bottle, a) NDC 13668-029-07, b) NDC 13668-596-07, Manufactured by Bio-Pharm, Inc. Levittown, PA, For Torrent Pharma Inc., Basking Ridge, NJ 07920..
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1347-2019·2019-06-19
Torrent Pharma Recalls Allergy Liquid Antihistamine Due to Bacterial Contamination
Torrent Pharma Inc. is recalling 118,080 bottles of Allergy Liquid Antihistamine due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Allergy Liquid Antihistamine, Diphenhydramine HCl USP 12.5 mg/5 mL), Alcohol free, 4 FL. oz. (118 mL) bottle, NDC: 59741-119-06, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Assured.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1371-2019·2019-06-19
Torrent Pharma Recalls Nasal Decongestant Liquid Due to Bacterial Contamination
Torrent Pharma Inc is recalling specific lots of Nasal Decongestant Liquid due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Nasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg in each teaspoonful, 4 Fl. oz. (118 mL) bottle, NDC:0536-1850-97, Distributed by Rugby Laboratories, Livonia MI 48152.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1362-2019·2019-06-19
Torrent Pharma Recalls Acetic Acid Otic Solution Due to Bacterial Contamination
Torrent Pharma is recalling specific lots of Acetic Acid Otic Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Acetic Acid Otic Solution, USP, 2%, Rx Only, 15 mL bottle, NDC: 64980-424-15, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Distributed by Rising Pharmaceuticals Ins Saddie Brook, NJ 07663.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1350-2019·2019-06-19
Torrent Pharma Recalls Robafen AC Oral Solution Due to Bacterial Contamination
Torrent Pharma Inc. is recalling Robafen AC Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Robafen AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC:0904-6479-16, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1378-2019·2019-06-19
Torrent Pharma Recalls Hemorrhoidal Suppositories Due to Bacterial Contamination
Torrent Pharma is recalling 82,872 bottles of Hemorrhoidal Suppositories due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 Rectal Suppositories per carton, NDC: 0536-1389-12, Distributed by Rugby Laboratories, Livonia MI 48152 USA.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1336-2019·2019-06-19
Pharm D Solutions Recalls Testosterone Vials Due to Sterility Concerns
Pharm D Solutions is recalling 704 vials of Testosterone 200 mg/mL due to a lack of sterility assurance. The affected product was distributed nationwide.
Product
Testosterone 200 mg/mL, 30 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846, NDC 69699-1702-30
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1364-2019·2019-06-19
Torrent Pharma Recalls Guaifenesin DAC Oral Solution Due to Contamination
Torrent Pharma Inc. is recalling specific lots of Guaifenesin DAC Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Guaifenesin DAC Oral Solution, Sugar free, (Guaifenesin, Pseudoephedrine HCl and Codeine Phosphate Oral Solution, USP), Expectorant, Nasal Decongestant, Cough Suppressant, 100 mg/30 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 16571-301-16, Manufactured by Bio-Pharm Inc., L
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1348-2019·2019-06-19
Torrent Pharma Recalls Children's Mapap Acetaminophen Liquid Due to Contamination
Torrent Pharma is recalling Children's Mapap Acetaminophen Liquid due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Children's Mapap Acetaminophen Liquid, Fever reducer, Pain reliever, Alcohol free, Aspirin free, Cherry flavored, acetaminophen 160 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle, NDC 0904-1985-20, b) One Pint (473 mL) bottle, NDC: 0904-1985-16, Distributed by Major Pharmaceuticals, L
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1351-2019·2019-06-19
Torrent Pharma Recalls Robafen DM Syrup Due to Bacterial Contamination Risk
Torrent Pharma is recalling Robafen DM Syrup due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Robafen DM Syrup (Dextromethorphan HBr, USP 20 mg/10 mL and Guaifenesin, USP 200 mg/10 mL), a) 4 oz. bottle, NDC: 0904-0053-00, b) 8 oz. bottle, NDC: 0904-0053-09, c) 16 oz. bottle, NDC:0904-0053-16, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1357-2019·2019-06-19
Biscolax Laxative Suppositories Recalled for Potential Bacterial Contamination
Torrent Pharma is recalling Biscolax Laxative suppositories due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Biscolax Laxative (Bisacodyl, USP 10 mg), a) 12 suppositories per carton, NDC: 0904-5058-12, b) 100 suppositories per carton, NDC: 0904-5058-60, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1360-2019·2019-06-19
Torrent Pharma Recalls Hyoscyamine Sulfate Elixir Due to Bacterial Contamination Risk
Torrent Pharma is recalling Hyoscyamine Sulfate Elixir due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Hyoscyamine Sulfate Elixir 0.125 mg per 5 mL, Rx Only, 473 mL (16 oz.) bottle, NDC:39328-048-16, Patrin Pharma, Skokie IL 60076.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1358-2019·2019-06-19
Torrent Pharma Recalls Cyproheptadine Syrup Due to Bacterial Contamination Risk
Torrent Pharma is recalling Cyproheptadine Hydrochloride Syrup due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5mL, 473 mL (16 FL. oz.) bottle, NDC: 39328-044-16, Patrin Pharma, Skokie, IL 60076.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1331-2019·2019-06-19
Pharm D Solutions Recalls Sermorelin/GHRP-2 Vials Due to Sterility Concerns
Pharm D Solutions, LLC is recalling Sermorelin/GHRP-2 9 mg/9 mg vials because they may lack sterility assurance. The recall covers 6 vials distributed nationwide.
Product
Sermorelin/GHRP-2 9 mg/9 mg vials Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1383-2019·2019-06-19
Torrent Pharma Recalls Hydrocodone Oral Solution Due to Bacterial Contamination
Torrent Pharma Inc. is recalling specific lots of Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC: 59741-262-16 Manufactured by Bio-Pharm Inc., Levittown, PA 19057 USA.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1328-2019·2019-06-19
Pharm D Solutions Recalls Lipo MIC-12 Injectable Vials for Sterility Concerns
Pharm D Solutions, LLC is recalling 669 vials of Lipo MIC-12 injectable solution due to a lack of sterility assurance. The product was distributed nationwide.
Product
Lipo MIC-12 (Methylcobalamin, USP 1mg, Methionine USP 15mg, Inositol, FCC 50mg, Choline Chloride, FCC 100 mg) 10 mL Injectable vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1352-2019·2019-06-19
Torrent Pharma Recalls Banophen Oral Solution Due to Bacterial Contamination Risk
Torrent Pharma Inc is recalling Banophen Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor, (Diphenhydramine HCl, USP) Each teaspoonful contains diphenhydramine hydrochloride, USP 12.5 mg, a) 4 Fl. oz. (118 mL) bottle, NDC: 0904-1228-00, b) One Pint (473 mL) bottle, NDC: 0904-5174-16, Distributed by Major
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-1400-2019·2019-06-19
Synthetopes Recalls Sn-DMSA Solution Due to Processing Control Deficiencies
Synthetopes Inc. is recalling Sn-DMSA solution vials nationwide due to a lack of processing controls. The product is not for direct injection.
Product
Sn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1343-2019·2019-06-19
B. Braun Recalls Heparin Sodium Bags Due to Low Potency
B. Braun Medical Inc. is recalling 40,176 bags of Heparin Sodium in Dextrose because testing showed the drug had lower potency than required by USP specifications.
Product
HEPARIN SODIUM IN DEXTROSE — HEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1404-2019·2019-06-19
Synthetopes Recalls Sn-DTPA Kit Due to Lack of Processing Controls
Synthetopes Inc is recalling 82 vials of Sn-DTPA Kit 10 mg nationwide due to a lack of processing controls.
Product
Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1436-2019·2019-06-19
Geritrex Recalls Senna Syrup Due to Atypical Odor and Taste
Geritrex, LLC is recalling 1,536 bottles of Senna Syrup due to reports of atypical odor and unpleasant taste.
Product
Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NY 10941, NDC 53807-556-08
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1395-2019·2019-06-19
Pecgen DMX Recalled for Incorrect Pediatric Dosage Labeling
Novis PR, Inc. is recalling Pecgen DMX cough syrup because a typo on the label provides incorrect dosage instructions for children.
Product
PECGEN DMX — PECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN)
Category
Drug
Distribution
1 state

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7826–7850 of 17974