Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. 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.

4451–4475 of 4878

SevereFDA (Drugs)·D-0193-2022·2021-11-17
TRI-MIX PAPAVERINE Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 20/PHENTOLAMINE 1/PGE-1 20 injectable due to lack of assurance of sterility. The product was distributed in the United States including Washington, D.C. and Puerto Rico.
Product
TRI-MIX PAPAVERINE 20/PHENTOLAMINE 1/PGE-1 20 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0143-2022·2021-11-17
Sermorelin Acetate/Ipamorelin Vials Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Sermorelin Acetate 15MG/Ipamorelin 15MG lyophilized vials due to lack of assurance of sterility. The affected lot was distributed across the United States, Washington, D.C., and Puerto Rico.
Product
SERMORELIN ACETATE 15MG/IPAMORELIN 15MG - LYOPHILIZED 15MG/15MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0149-2022·2021-11-17
Vitamin D3 Injectable from Talon Compounding Pharmacy Recalled for Sterility Assurance
Talon Compounding Pharmacy is recalling Vitamin D3 100,000 IU/mL injectable due to lack of assurance of sterility. The product was distributed across the United States, including Washington, D.C. and Puerto Rico.
Product
VITAMIN D3 100,000 IU/ML INJECTABLE 100,000IU/ML, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
0 states
SevereFDA (Drugs)·D-0169-2022·2021-11-17
Testosterone Cypionate Injectable Recalled for Lack of Sterility Assurance
Talon Compounding Pharmacy is recalling testosterone cypionate 100 mg/mL injectable in 12 lots due to lack of assurance of sterility. The affected product was distributed across the United States.
Product
TESTOSTERONE CYPIONATE 100MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Category
Drug
Distribution
0 states
SevereFDA (Food)·F-0112-2022·2021-11-10
Raw Yellow Onions from Mexico Recalled for Salmonella Oranienburg
ProSource Produce LLC is recalling whole raw yellow onions imported from Chihuahua, Mexico, due to potential contamination with Salmonella Oranienburg. The affected onions were distributed across multiple U.S. states and Canadian provinces under various brand names.
Product
Whole raw YELLOW onions are imported from Chihuahua of MEXICO. Products are packaged in 50 lb., 25 lb., 10 lb., 5 lb., 3 lb., and 2 lb. mesh sacks and in 50 lb., 40 lb., 25 lb., 10 lb., and 5 lb. cartons. Products are distributed and/or sold under the brands Big Bull, Mark
Category
Food
Distribution
35 states
SevereFDA (Food)·F-0094-2022·2021-11-10
Chicken Flavor Food Additive Recalled for Salmonella Contamination
Givaudan Flavours Corp is recalling a natural chicken rotisserie flavor product due to positive Salmonella detection. The affected batch was distributed to a single account in Indiana.
Product
AY-259-396-6 Nat Chicken (rotisserie) Flavor WONF 18.144kg packages packaged in brown square boxes with blue plastic interior
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0111-2022·2021-11-10
Raw Red Onions Recalled Due to Salmonella Oranienburg Risk
ProSource Produce LLC has recalled whole raw red onions imported from Chihuahua, Mexico, due to potential Salmonella Oranienburg contamination. The affected product was distributed across multiple U.S. states and Canadian provinces.
Product
Whole raw RED onions are imported from Chihuahua of MEXICO. Products are packaged in 50 lb., 25 lb., 10 lb., 5 lb., 3 lb., and 2 lb. mesh sacks and in 50 lb., 40 lb., 25 lb., 10 lb., and 5 lb. cartons. Products are distributed and/or sold under the brands Big Bull, Markon
Category
Food
Distribution
35 states
SevereFDA (Drugs)·D-0093-2022·2021-11-10
Cubicin daptomycin injection recalled for glass particle contamination
Merck Sharp & Dohme Corp. is recalling Cubicin (daptomycin for injection) 500 mg vials due to the presence of glass particles. The recall affects a single lot distributed nationwide.
Product
Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx only. Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manuf. by: Baxter Pharmaceuticals LLC., Bloomington, IN 47403, USA, NDC: 67919-011-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0119-2022·2021-11-10
Monoject Prefilled Syringe Plunger Defect Recall: Air Reintroduction Risk
Monoject prefilled syringes in medical kits may have a plunger that rebounds after air expulsion, potentially reintroducing air into the syringe. This FDA Class I recall affects approximately 9,378 units distributed in Florida and Pennsylvania.
Product
Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience Kits: AMS-9041CP Leaderflex Insertion Kit with Ultrasound, AMS-9046CP-1 Insertion Tray-RX, AMS8939A Universal Procedure Pack w/Sp
Category
Medical Device
Distribution
2 states
SevereFDA (Food)·F-0115-2022·2021-11-10
Green Giant Fresh White Onions Recalled for Salmonella Risk
Green Giant Fresh whole white onions in 2 lb. mesh bags have been recalled due to potential Salmonella Oranienburg contamination. Affected products were distributed in North Dakota and Minnesota.
Product
Green Giant Fresh whole WHITE onions in 2 lbs. flexible mesh bags, (25/2 lb. pkg per case) - UPC 60580600218-2.
Category
Food
Distribution
2 states
SevereFDA (Drugs)·D-0089-2022·2021-11-10
Irbesartan and Hydrochlorothiazide Tablets Recalled for Impurity Contamination
Lupin Pharmaceuticals is recalling Irbesartan and Hydrochlorothiazide Tablets 150/12.5 mg due to detection of the impurity N-nitrosoirbesartan in the active pharmaceutical ingredient, which resulted from CGMP deviations.
Product
Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx only
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0113-2022·2021-11-10
ProSource Produce white onions recall for Salmonella contamination
ProSource Produce LLC is recalling whole raw white onions imported from Mexico due to potential Salmonella Oranienburg contamination. The onions were distributed across 33 U.S. states and Canada.
Product
Whole raw WHITE onions are imported from Chihuahua of MEXICO. Products are packaged in 50 lb., 25 lb., 10 lb., 5 lb., 3 lb., and 2 lb. mesh sacks and in 50 lb., 40 lb., 25 lb., 10 lb., and 5 lb. cartons. Products are distributed and/or sold under the brands Big Bull, Marko
Category
Food
Distribution
35 states
SevereFDA (Food)·F-0158-2022·2021-11-10
Seafood Products Recalled for Salmonella Contamination Risk
Northeast Seafood Products is recalling multiple seafood products including haddock, salmon, and trout due to potential Salmonella contamination. The products were distributed to restaurants and grocery stores in Colorado between May and October 2021.
Product
Haddock, Monkfish, Bone-in Trout, Grouper, Red Snapper, Red Rock Cod, Ocean Perch, Pacific Cod, Halibut, Coho Salmon, Atlantic Salmon Portions, Lane Snapper, Tilapia, All Natural Salmon Fillet, Pacific Sole, and Farm Raised Striped Bass
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0114-2022·2021-11-10
Green Giant Fresh Whole Yellow Onions Recalled for Salmonella Risk
POTANDON PRODUCE LLC is recalling Green Giant Fresh whole yellow onions sold in 2 lb., 3 lb., and 5 lb. bags due to potential Salmonella Oranienburg contamination. The product was distributed in North Dakota and Minnesota.
Product
Green Giant Fresh whole YELLOW onions in 2 lbs. flexible mesh bags, (25/2 lb. pkg. per case) - UPC 60580600120-8. Green Giant Fresh whole YELLOW onions in 3 lbs. flexible mesh bags, (16/3 lb. pkg. per case) - UPC 60580600123-9. Green Giant Fresh whole YELLOW onions in 5 lbs. fl
Category
Food
Distribution
2 states
SevereFDA (Drugs)·D-0090-2022·2021-11-10
Lupin Pharmaceuticals Irbesartan/Hydrochlorothiazide Tablets Recalled for Impurity
Lupin Pharmaceuticals is recalling Irbesartan and Hydrochlorothiazide Tablets USP (300/12.5 mg) in 30-count and 90-count bottles due to detection of the impurity N-nitrosoirbesartan in the active pharmaceutical ingredient.
Product
Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx only
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0087-2022·2021-11-10
Irbesartan Tablets Recalled for Impurity in Active Ingredient
Lupin Pharmaceuticals is recalling Irbesartan tablets due to the detection of N-nitrosoirbesartan impurity in the active pharmaceutical ingredient. The recall affects 30-count and 90-count bottles distributed nationwide.
Product
IRBESARTAN — IRBESARTAN (IRBESARTAN)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0194-2022·2021-11-10
IPL Coupling Gel and EcoGel 200 Recalled for Bacterial Contamination
Lumenis, Inc. is recalling IPL Coupling Gel and EcoGel 200 due to potential bacterial contamination. Approximately 11,064 units were distributed worldwide.
Product
IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012) manufactured by Eco-Med Pharmaceutical
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0092-2022·2021-11-10
Methocarbamol Tablets Mislabeled with Incorrect Strength
Bryant Ranch Prepack is recalling Methocarbamol 500mg tablets nationwide because the bottles are mislabeled—they actually contain 750mg tablets. The affected lot was distributed in 30-, 60-, and 90-count bottles.
Product
Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (NDC 7133517957) bottles, Rx only, Prinston Laboratories, Packaged by Bryant Ranch Prepack Burbank, CA 91504
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0048-2022·2021-11-03
Compounded Anabolic Steroid Product Recalled for Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling a compounded anabolic steroid product due to FDA concerns about sterility assurance identified during inspection. The product was distributed to approximately 494 patients in seven states.
Product
TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
SevereFDA (Drugs)·D-0032-2022·2021-11-03
Ascorbic Acid Injectable Solution Recalled for Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling Ascorbic Acid (Non-Corn) 500mg/mL Solution for Injection due to lack of assured sterility identified during an FDA inspection. The affected product was distributed to approximately 494 patients in seven states.
Product
ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
SevereFDA (Drugs)·D-0053-2022·2021-11-03
Acetylcysteine 10% ophthalmic solution recalled for sterility assurance concerns
Red Mountain Compounding Pharmacy is recalling Acetylcysteine 10% ophthalmic solution due to lack of sterility assurance identified during an FDA inspection. Approximately 494 patients received prescriptions for the product across seven states.
Product
ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
SevereFDA (Drugs)·D-0046-2022·2021-11-03
Test Cyp Injectable Drug Recalled for Sterility Assurance Defects
First Royal Care Compounding Pharmacy is recalling Test Cyp 50mg/ml in ethyl oleate oil due to FDA inspection findings that raised concerns about sterility assurance. About 494 patients in seven states received prescriptions for the affected product.
Product
TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
SevereFDA (Drugs)·D-0044-2022·2021-11-03
TEST CYP 200MG/ML injection recalled due to sterility assurance concerns
Red Mountain Compounding Pharmacy is recalling TEST CYP 200MG/ML MDV ETHYL OLEATE due to FDA inspection findings of lack of assurance of sterility. The product was distributed to approximately 494 patients across seven states.
Product
TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
SevereFDA (Drugs)·D-0028-2022·2021-11-03
Calcium Chloride Injection Recalled Due to Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling Calcium Chloride 100 mg/mL multi-dose vial injection due to lack of assurance of sterility identified during FDA inspection. The product was distributed to approximately 494 patients across seven states.
Product
Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
SevereFDA (Drugs)·D-0033-2022·2021-11-03
Ascorbic/Glutathione Eye Solution Recalled for Sterility Concerns
Red Mountain Compounding Pharmacy is recalling an ascorbic/glutathione eye solution because FDA inspection identified concerns about sterility assurance during manufacturing.
Product
ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states