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.

11876–11900 of 29163

SevereFDA (Drugs)·D-1345-2019·2019-06-19
Torrent Pharma Recalls Risperidone Oral Solution Due to Bacterial Contamination
Torrent Pharma Inc. is recalling Risperidone Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 13668-589-06, Manufactured by Bio-Pharm Inc., Levittown PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1379-2019·2019-06-19
Torrent Pharma Recalls Anu-Med Hemorrhoidal Suppositories Due to Bacterial Contamination
Torrent Pharma is recalling Anu-Med Hemorrhoidal Suppositories due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 suppositories per carton, NDC: 0904-7688-22, Distributed by Major Pharmaceuticals, Livonia MI 48152.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1339-2019·2019-06-19
Pharm D Solutions Recalls Trimix Injectable Due to Sterility Concerns
Pharm D Solutions is recalling specific lots of Trimix injectable vials due to a lack of sterility assurance.
Product
Trimix 30mg/1 mg/10mcg/mL ( 30 mg Papaverine, 1mg phentolamine mesylate, 30 mcg alprostadil) Injectable, 5mL 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-1376-2019·2019-06-19
Torrent Pharma Recalls Hydrocortisone Acetate Suppositories Due to Contamination Risk
Torrent Pharma Inc. is recalling Hydrocortisone Acetate Suppositories due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Hydrocortisone Acetate Suppositories, 25 mg, Rx Only, For rectal administration, a) 12 Adult Suppositories per carton, NDC: 59741-301-12, b) 24 Adult Suppositories per carton, NDC: 59741-301-24, Manufactured by Bio-Pharm Inc., Levittown PA 19057.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1334-2019·2019-06-19
Pharm D Solutions Recalls Sermorelin/GHRP-2 &6 Vials for Sterility Concerns
Pharm D Solutions, LLC is recalling Sermorelin/GHRP-2 &6 vials due to a lack of sterility assurance. The recall affects products distributed nationwide in the United States.
Product
Sermorelin/GHRP-2 &6 (9-9-9-mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1335-2019·2019-06-19
Pharm D Solutions Recalls Sermorelin Vials Due to Sterility Concerns
Pharm D Solutions, LLC is recalling Sermorelin/GHRP-2 &6 vials nationwide because the product lacks sterility assurance.
Product
Sermorelin/GHRP-2 &6 (9-9-9 mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1377-2019·2019-06-19
Torrent Pharma Recalls Laxative Suppositories Due to Potential Bacterial Contamination
Torrent Pharma Inc is recalling Laxative Suppositories (Bisacodyl USP, 10 mg) due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Laxative Suppositories (Bisacodyl USP, 10 mg), a) 12 Suppositories per carton, NDC: 0536-1355-12, b) 100 Suppositories per carton, NDC: 0536-1355-01, Distributed 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-1333-2019·2019-06-19
Pharm D Solutions Recalls Sermorelin Vials Due to Sterility Concerns
Pharm D Solutions is recalling 100 vials of Sermorelin/GHRP-2 & 6 due to a lack of sterility assurance. The products were distributed nationwide in the United States.
Product
Sermorelin/GHRP-2 & 6 (3-3-3 MG) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1349-2019·2019-06-19
Torrent Pharma Recalls Robafen Cough Formula Due to Potential Bacterial Contamination
Torrent Pharma is recalling Robafen Cough Formula Expectorant due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Robafen Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 mL), a) 4 Fl. oz. (118 mL) bottle, NDC: 0904-0061-00, b) One Pint ( 473 mL) bottle, NDC: 0904-0061-16, Distributed by Major Pharmaceuticals, Livonia MI 48152.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1367-2019·2019-06-19
Kid Kare Children's Cough/Cold Liquid Recalled for Bacterial Contamination
Torrent Pharma is recalling Kid Kare Children's Cough/Cold Liquid due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Kid Kare Childrens Cough/Cold Liquid, Antihistamine, Cough Suppressant, Nasal Decongestant, Cherry Flavored, Alcohol Free, (Chlorpheniramine Maleate, USP 2 mg, Dextromethorphan HBr, USP 10 mg, Pseudoephedrine HCl, USP 30 mg in each 2 tsp (10mL)), 4 Fl. oz. bottle, NDC…
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1370-2019·2019-06-19
Torrent Pharma Recalls Diphenhydramine Oral Solution Due to Bacterial Contamination
Torrent Pharma Inc is recalling Diphenhist Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0770-97, b) One Pint (473 mL) bottle., NDC: 0536-0770-85, Distributed by Rugby Laboratories, Livonia, MI 48152.
Category
Drug
Distribution
0 states
SevereFDA (Devices)·Z-1705-2019·2019-06-19
Edwards Lifesciences Recalls IntraClude Intra-Aortic Occlusion Devices Due to Balloon Rupture Risk
Edwards Lifesciences is recalling IntraClude Intra-Aortic Occlusion Devices because the balloon may rupture during cardiopulmonary bypass, potentially obscuring the operative site and requiring a change in surgical strategy.
Product
IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-aortic occlusion device is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude intra-aortic occlusion device…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1372-2019·2019-06-19
Torrent Pharma Recalls Lactulose Solution Due to Potential Bacterial Contamination
Torrent Pharma Inc. is recalling 96,060 bottles of Lactulose Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Lactulose Solution, USP 10 g/15 mL, For Oral Administration, Rx Only, a) 16 FL. oz., NDC: 13668-580-10, b) 32 FL. oz., NDC: 13668-580-12, Manufactured by Bio-Pharm Inc., Levittown PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1329-2019·2019-06-19
Pharm D Solutions Recalls Nandrolone Decanoate Injectable Due to Sterility Concerns
Pharm D Solutions is recalling Nandrolone Decanoate 200 mg/mL injectable vials due to a lack of sterility assurance. The recall covers 50 vials distributed nationwide.
Product
Nandrolone Decanoate 200 mg/mL Injectable, 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-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-1374-2019·2019-06-19
Torrent Pharma Recalls Memantine Hydrochloride Oral Solution Due to Contamination
Torrent Pharma Inc is recalling 5,681 bottles of Memantine Hydrochloride Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551-12, Patrin Pharma
Category
Drug
Distribution
0 states
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-1403-2019·2019-06-19
Synthetopes Recalls Sn-d, l-Exametazime Due to Lack of Processing Controls
Synthetopes Inc is recalling Sn-d, l-Exametazime vials nationwide due to a lack of processing controls. The FDA classifies this as a Class II recall.
Product
Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C, Synthetopes, Inc.
Category
Drug
Distribution
Distributed nationwide
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-1324-2019·2019-06-19
Pharm D Solutions Recalls Human Chorionic Gonadotropin Vials for Sterility Concerns
Pharm D Solutions is recalling Human Chorionic Gonadotropin 10,000 IU vials due to a lack of sterility assurance. The recall affects 26 vials distributed nationwide.
Product
Human Chorionic Gonadotropin 10,000 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-1346-2019·2019-06-19
Torrent Pharma Recalls Children's Acetaminophen Liquid Due to Potential Bacterial Contamination
Torrent Pharma Inc is recalling 58,272 bottles of Children's Acetaminophen Liquid due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Children's Acetaminophen Liquid, 160 mg per 5 mL, Fever and Pain, Alcohol free, aspirin free, ibuprofen free, Cherry Flavor, 4 FL. oz. (118 mL) bottle, NDC: 59741-101-06, Manufactured by Bio-Pharm, Inc., Levittown PA 19057, Assured.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1359-2019·2019-06-19
Torrent Pharma Recalls Hyoscyamine Oral Drops Due to Bacterial Contamination Risk
Torrent Pharma is recalling Hyoscyamine Oral Drops due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Hyoscyamine Oral Drops 0.125 mg/mL, Rx Only, 15 mL bottle (0.5 FL. oz.), NDC: 39328-047-15, Manuf. for Patrin Pharma, Skokie IL 60076.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1375-2019·2019-06-19
Torrent Pharma Recalls Memantine Hydrochloride Oral Solution Due to Contamination Risk
Torrent Pharma Inc. is recalling 264 bottles of Memantine Hydrochloride Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Memantine Hydrochloride Oral Solution, 2 mg/mL, Rx Only, 12 FL. oz.. bottle, NDC: 13668-573-09, Manufactured By Bio-Pharm Inc., Levittown, PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-1354-2019·2019-06-19
Torrent Pharma Recalls Nasal Decongestant Spray Due to Potential Bacterial Contamination
Torrent Pharma is recalling specific lots of Nasal Decongestant Spray Regular due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.
Product
Nasal Decongestant Spray Regular, Oxymetazoline HCl 0.05%, a) 0.5 FL. oz. (15 mL) bottle, NDC:0904-5711-35, b) 1 FL. oz. (30 mL) bottle, NDC: 0904-5711-30, Distributed by Major Pharmaceuticals, Livonia MI 48152.
Category
Drug
Distribution
0 states