Massachusetts recalls
3,517 federal recalls affecting Massachusetts in the last 12 months - 155 Massachusetts-specific plus 3,362 nationwide. Sourced from CPSC, FDA, USDA, and NHTSA.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideEpstein-Barr Virus (EBV VCA & EBNA IgG) Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideDrug Test Small (4 substances)
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideIllegally Marketed
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideDiabetes HbA1c Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideD-Dimer Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideChlamydia Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideCandida Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideBlood Type Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGet TestedClass IINationwideAlcohol (ALC) Test Saliva
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceMedtronicClass IINationwideAurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
- 2025-12-10FDA-DeviceEnterixClass IINationwideInSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples.
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
- 2025-12-10FDA-DeviceFresenius KabiClass INationwideIVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
- 2025-12-10FDA-FoodGeneproClass IGenepro Whey 4th Generation Plasma Treated Protein, unflavored, Net Wt. 225g, 30 servings, packaged in a resealable mylar bag, UPC 850053365126, Manufactured For: Genepro Protein, Inc. 15000 Weston Parkway, Cary NC 27513 Front label reads, in part: "* LACTOSE FREE * DAIRY FREE *ALLERGEN FREE" Back label reads, in part: "OTHER INGREDIENTS: Hydrolyzed NiHPRO ProteinIsolate (Pea Protein Isolate, Rice Protein Isolate, Mungbean Protein Isolate, L-Lysine, L-Leucine, L-Threonine, L-Methionine). CONT
Product is mislabeled - the labeling contains incorrect ingredient information and fails to declare milk as an allergen
- 2025-12-10FDA-FoodRong ShingClass IIAojia Dried Red Bayberry; packaged in 5.6oz (160g) clear plastic bottle; UPC 6942514920327
Product contains undeclared sulfites (7.39mg/serving) and cyclamates
- 2025-12-10FDA-FoodAvion PharmaceuticalsClass IIIPrenate Chewable¿ A chewable Rx prenatal vitamin with a delicious chocolate flavor with Quatrefolic Dietary Supplement 30 Tablets Rx Only UPC 3 75854 30630 2 Manufactured for: Avion Pharmaceuticals, LLC Alpharetta, GA 30005
Undeclared Soy. The firm received positive test results for soy which is not listed on the label. The firm also noticed that the amount of boron in the product is listed as 250mg per serving instead of 250mcg per serving.
- 2025-12-10FDA-FoodPrime Food ProcessingClass IILava Bun with Salted Egg Yolk orange packaging (Frozen) Unsalted butter and cream are listed in the ingredient statement.
Products do not declare milk in the Contains statement or the ingredient statement.
- 2025-12-10FDA-FoodPrime Food ProcessingClass IILava Bun with Green Tea Flavor bright lime green packaging (Frozen) Unsalted butter and cream are listed in the ingredient statement.
Products do not declare milk in the Contains statement or the ingredient statement.
- 2025-12-10FDA-FoodPacific SeafoodClass IIIPacific Seafood Raw Blackened Shrimp Peeled & Deveined Tail-Off, refrigerated, farm-raised. Net wt. per tray 8 oz (227 g). UPC 0 27241 44630 5. Ingredients: Shrimp (Shrimp, Water, Salt, Sodium tripolyphosphate (to retain moisture), Blackened Seasoning (Sea Salt, Paprika, Spices, Onion, Garlic, Paprika Extract). CONTAINS: Shrimp (Crustacean Shellfish). Product of Ecuador. Packed and distributed by Pacific Seafood Group Clackamas, OR.
Undeclared Sulfite. Shrimp may contain 3.4mg Sulfur Dioxide per serving and label does not declare Sulfite.
- 2025-12-10FDA-FoodCostcoClass IICostco Item# 11444 Kirkland Signature Chicken Sandwich with Caesar Salad, refrigerated, packaged in clear plastic clamshell container. The net weight varies as it is sold by weight. This product contains 3oz. sealed packet of Caesar Dressing.
The 3oz. sealed packet of Caesar Dressing in Costco Chicken Sandwich w/ Caesar Salad may contain plastic material.
- 2025-12-10FDA-FoodCostcoClass IICostco Item# 19927 Kirkland Signature Caesar Salad, refrigerated, packaged in clear plastic clamshell container. The net weight varies as it is sold by weight. This product contains 3oz. sealed packet of Caesar Dressing.
The 3oz. sealed packet of Caesar Dressing in Costco Caesar Salad may contain plastic material.
- 2025-12-10FDA-FoodBlonde Beard'sClass IIBlonde Beard's Dojo Asian Wing Sauce, wing sauce hot sauce condiment, shelf stable, 2 years, glass bottle, 8 oz, Blonde Beard s. Responsible firm on label: Blonde Beard s 2230 S Braun Ct Lakewood, CO 80228.
Undeclared Soy
- 2025-12-10FDA-FoodWater PureClass IINationwideMy Bladder; Supports normal bladder tone & control; Dietary Supplement; packaged in white HDPE bottle with a white cap; bottle size is 150 CC; the net contents in 60 clear capsules containing brown powder
Product may be contaminated with E. coli O7:K1 (IAI39/ExPEC) and E. coli 1303
- 2025-12-10FDA-DrugBreckenridgeClass IINationwideDuloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- 2025-12-10FDA-DrugBreckenridgeClass IINationwideDuloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- 2025-12-10FDA-DrugSafecor HealthClass IIHaloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26605. NDC: 67457-426-12 with Safecor Health LLC KITCHECK RFID Tag attached with incorrect serial numbers: KITCHECK 8001-03A3,00000000,003A-2560, and 8001-03A3,00000000,003A-2D3B.
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
- 2025-12-10FDA-DrugBlossom PharmaceuticalsClass IINationwideWecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04.
cGMP deviations
- 2025-12-10FDA-DrugBlossom PharmaceuticalsClass IINationwideGlobe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceuticals USA 101 NE, Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, NDC 69396-086-02.
cGMP deviations
- 2025-12-10FDA-DrugBlossom PharmaceuticalsClass IINationwideGlobe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, USA, NDC 69396-087-55.
cGMP deviations
- 2025-12-10FDA-DrugBlossom PharmaceuticalsClass IINationwideGlobe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301 USA, Made in India, NDC 69396-087-01.
cGMP deviations
- 2025-12-10FDA-DrugBlossom PharmaceuticalsClass IINationwideNivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, Made in India, NDC 75834-170-02.
cGMP deviations
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