The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

11901–11925 of 29163

  • 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-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-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-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-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-1337-2019·2019-06-19

    Pharm D Solutions Recalls Testosterone Cyp/Pro Vials for Sterility Concerns

    Pharm D Solutions is recalling 371 vials of Testosterone Cyp/Pro 95/5% due to a lack of sterility assurance. The affected prescription medication was distributed nationwide.

    Product
    Testosterone Cyp/Pro 95/5%, 10 mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1356-2019·2019-06-19

    Torrent Pharma Recalls Pedia Relief Cough-Cold Oral Solution Due to Contamination

    Torrent Pharma Inc is recalling Pedia Relief Cough-Cold Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Pedia Relief Cough-Cold Oral Solution, Alcohol free, antihistamine, cough suppressant, nasal decongestant, Chlorpheniramine Maleate, USP 2 mg; Dextromethorphan HBr, USP 10 mg; Pseudoephedrine HCl, USP 30 mg in each 2 tsp (10 mL)), 4 Fl. oz. (118 mL) bottle, NDC:0904-5050-20…
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1322-2019·2019-06-19

    Pharm D Solutions Recalls Bacteriostatic Water for Injection Vials

    Pharm D Solutions, LLC is recalling 716 vials of Bacteriostatic Water for Injection due to a lack of sterility assurance.

    Product
    Bacteriostatic Water for Injection, 10 mL vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1384-2019·2019-06-19

    Torrent Pharma Recalls Hydrocodone and Homatropine Oral Solution Due to 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:13668-577-10 Distributed by Torrent Pharma Inc., Basking Ridge, NJ 07920.
    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
  • SevereFDA (Drugs)·D-1330-2019·2019-06-19

    Pharm D Solutions Recalls Sermorelin/Ipamorelin Vials Due to Sterility Concerns

    Pharm D Solutions is recalling Sermorelin/Ipamorelin 18 mg/15 mg vials because they lack sterility assurance. The recall covers 24 vials distributed nationwide.

    Product
    Sermorelin/Ipamorelin 18 mg/15 mg, 10mL vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1325-2019·2019-06-19

    Pharm D Solutions Recalls Human Chorionic Gonadotropin Vials for Sterility Concerns

    Pharm D Solutions is recalling 279 vials of Human Chorionic Gonadotropin 5,000 IU due to a lack of sterility assurance. The recall covers products distributed nationwide.

    Product
    Human Chorionic Gonadotropin 5,000 IU vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1405-2019·2019-06-19

    Synthetopes Recalls Sn-Tetrofosmin Kits Due to Processing Control Deficiencies

    Synthetopes Inc is recalling Sn-Tetrofosmin Kits nationwide due to a lack of processing controls. All lots remaining within their expiry date are affected.

    Product
    Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1326-2019·2019-06-19

    Pharm D Solutions Recalls Human Chorionic Gonadotropin Vials for Sterility Concerns

    Pharm D Solutions is recalling 104 vials of Human Chorionic Gonadotropin 12,000 IU due to a lack of sterility assurance.

    Product
    Human Chorionic Gonadotropin 12,000 IU vials Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1355-2019·2019-06-19

    Torrent Pharma Recalls Robafen DM Cough Syrup Due to Bacterial Contamination

    Torrent Pharma Inc is recalling Robafen DM Cough Sugar-Free Clear Cough Expectorant due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Robafen DM Cough Sugar-Free Clear Cough Expectorant (Dextromethorphan HBr, USP 20 mg), Expectorant (Guaifenesin, USP 200 mg in each 2 teaspoonfuls (10mL)), 4 Fl. oz. (118 mL) bottle, NDC: 0904-6306-20, Distributed by Major Pharmaceuticals, Livonia MI 48152.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1373-2019·2019-06-19

    Torrent Pharma Recalls Lactulose Solution Due to Potential Bacterial Contamination

    Torrent Pharma Inc. is recalling specific lots of Lactulose Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Lactulose Solution, USP 10 g/15 mL, For Oral or Rectal Administration, Rx Only, 16 FL. oz. Bottle, NDC:13668-574-10, Manufactured By Bio-Pharm, Levittown, PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1366-2019·2019-06-19

    Torrent Pharma Recalls Acetaminophen Oral Solution Due to Bacterial Contamination

    Torrent Pharma is recalling Pain & Fever Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Pain & Fever Oral Solution (Acetaminophen 160 mg/5 mL), Sugar free, Aspirin & Alcohol free, Cherry flavored, a) 4 Fl. oz. bottle, NDC: 0536-0122-97, b) One Pint (473 mL) bottle, NDC: 0536-0122-85, Distributed by Rugby Laboratories, Lavonia, MI 48152 USA.
    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-1380-2019·2019-06-19

    Torrent Pharma Recalls Cetirizine Hydrochloride Oral Solution Due to Contamination Risk

    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 1 mg/mL, For Oral Use Only, Rx Only, 120 mL bottle, NDC 23155-292-51, Mfd for Heritage Pharmaceuticals Inc., Eatontown, NJ 07724.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-1444-2019·2019-06-19

    Hearthside recalls 7-Eleven Italian Job sandwiches due to undeclared egg

    Hearthside Food Solutions is recalling 7-Eleven The Italian Job refrigerated sandwiches because they contain undeclared egg. The recall affects 1,038 units sold in the Chicago area.

    Product
    7-Eleven The Italian Job refrigerated sandwich, clear plastic overwrap net wt. 9.7 oz.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1332-2019·2019-06-19

    Pharm D Solutions Recalls Sermorelin/GHRP-2 Vials Due to Sterility Concerns

    Pharm D Solutions is recalling 66 vials of Sermorelin/GHRP-2 because they lack sterility assurance. The products were distributed nationwide.

    Product
    Sermorelin/GHRP-2 9 mg/6 mg vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V472000·2019-06-19

    BMW Recalls 2008-2012 Models for Battery Cable Defect

    BMW is recalling specific 2008-2012 models because a battery cable connection may degrade, causing power loss and stalling.

    Product
    BMW — BMW M3, 328I, 328XI, 335D
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1327-2019·2019-06-19

    FDA Recalls Ipamorelin Acetate Injectable Vials Due to Sterility Concerns

    Pharm D Solutions is recalling 11 vials of Ipamorelin Acetate 9 mg/9mL Injectable due to a lack of sterility assurance.

    Product
    Ipamorelin Acetate 9 mg/9mL Injectable vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
    Category
    Drug
    Distribution
    Distributed nationwide