Massachusetts FDA Recalls — Food, Drug, and Medical Device (Past 90 Days)
Source: U.S. Food and Drug Administration (FDA) · openFDA Enforcement API · trailing 90-day window
65
Total active
25
Food
20
Drug
20
Medical Device
What "class" means
The FDA assigns every recall one of three classes based on the severity of harm if a person uses the product:
Class I
Reasonable probability of serious adverse health consequences or death. Stop using immediately and follow return instructions.
Class II
Use may cause temporary or medically reversible adverse effects. Probability of serious harm is remote.
Class III
Not likely to cause adverse health effects — usually quality, labeling, or minor purity issues.
🥗 Food Recalls
Jun 24, 2026
H-1149-2026
Fresh to You Burger Chicken Fillet, SKU 10150, Net wt. 5oz. Product is refrigerated. UPC 1
Recalled by Fresh & Ready Foods LLC
Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Fillet sandwich. Raw breaded chic
Jun 24, 2026
H-1148-2026
Fresh to You Burger Chicken Fillet Deluxe with Bacon, SKU 10303, Net wt. 5.9oz. Product is
Recalled by Fresh & Ready Foods LLC
Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Deluxe With Bacon sandwich. Raw b
Jun 23, 2026
H-1143-2026
Bakr Brown Butter Chocolate Chunk Ready to Bake Cookie Dough, 8-oz pouch 12 cookies per po
Recalled by Bear Stewart Co
undeclared soy
Jun 23, 2026
H-1144-2026
Trafa Pharmaceuticals Inc. brand ORGANIC MORINGA LEAF POWDER; NET WEIGHT: 15 KGS; packaged
Recalled by Trafa Pharmaceutical Inc.
Potential contamination with Salmonella
Jun 23, 2026
H-1150-2026
High Valley Orchard Chocolate Covered Raisins, net wt. 15oz. per package, each case contai
Recalled by Lehi Valley Trading Company, Inc
Undeclared Peanut. High Valley Orchard Chocolate Covered Raisins contains unintended undeclared peanut due to mis-packag
Jun 17, 2026
H-1129-2026
MorningStar Farms Buffalo Chik'n Nuggets, 100% Plant Protein Vegan Nuggets, Net Wt. 10.5 o
Recalled by MARS SNACKING
Potential contamination with plastic material
Jun 17, 2026
H-1135-2026
Vista MAX; Dietary Supplement, 90 Capsules. Serving Size: 4 Capsules; Distributed by: Visi
Recalled by Provision Health Corp. dba PH Labs
Dietary supplement product Vista MAX contains undeclared Yellow#5.
Jun 17, 2026
H-1134-2026
Ocular Plus with Lutein, Zeaxanthin, and Omega 3-6-9; Dietary Supplement, 200 Capsules. Se
Recalled by Provision Health Corp. dba PH Labs
Dietary supplement product Ocular Plus contains undeclared Yellow#5.
Jun 17, 2026
H-1130-2026
MorningStar Farms Hot & Spicy Sausage Patties, 100% Plant Protein Vegan Sausage Patties, N
Recalled by MARS SNACKING
Potential contamination with plastic material
Jun 14, 2026
H-1125-2026
FIRST STREET Dark Chocolate Raisins Net Wt. 9 oz. (255g) UPC 797565011830 INGREDIENTS: DA
Recalled by Western Mixers Produce & Nuts, Inc.
Undeclared peanuts.
Jun 12, 2026
H-1137-2026
a.) nara organics brand; Whole Milk Organic Infant Formula; Milk-based Powder with Iron; 0
Recalled by NARA ORGANICS INC
Product may be contaminated with Clostridium botulinum.
Jun 10, 2026
H-1147-2026
Alabama Banana Pudding Marshmallow, 4 ounce 16 pieces of individual marshmallows packaged
Recalled by Wondermade LLC
Foreign material: small metal pieces
Jun 9, 2026
H-1136-2026
Pepperoni Rolls, Net Wt. 5 oz (141g), individually packaged in a clear plastic bag, UPC 60
Recalled by Fry Pie Factory LLC
Undeclared allergen (milk) and process deviation (product not held under refrigeration as required)
Jun 9, 2026
H-1151-2026
Plastic 1-gallon clear pail blue label which reads in part as "BLUE RIBBON CLASSICS FRENCH
Recalled by Wells Enterprises, Inc.
Elevated coliforms
Jun 8, 2026
H-0950-2026
Al Yaman Halawa Extra Pistachio 907g (31.994 oz) plastic jars, UPC 5 287000 098083, 12 ret
Recalled by GREENWORLD FOOD EXPRESS (USA) LLC
Product may be contaminated with Salmonella
Jun 4, 2026
N/A
Le Chef Bakery branded Mini Italian Pastry Assortment; 2.5 lbs/cs; (40 pieces/cs); package
Recalled by Le Chef Bakery
undeclared colors (yellow#5)
Jun 2, 2026
H-0938-2026
MMB of Louisiana Pasteurized Donor Human Milk, Volume: 3 oz, Cal/Oz: 19, 0.9 g/dL Protein,
Recalled by Mothers' Milk Bank of Louisiana at Ochsner Baptist
Potential physical contamination: dark spot was noticed on the bottom of container.
Jun 1, 2026
H-1080-2026
Dried Herring Fish 7 oz.
Recalled by Prime Food Processing LLC.
Improperly eviscerated which may result in Clostridium botulinum contamination
May 28, 2026
H-1095-2026
Motor City Pizza Co. 5 Cheese Bread Single retail pack; 22.43 oz. (1 lb. 6.4 oz.) 636g UPC
Recalled by Champion Foods, LLC
potential salmonella contamination
May 27, 2026
H-1146-2026
Wise Onion Rings, 3.75 oz, metalized film in cardboard cartons, 14 bags per case,
Recalled by Wise Foods Inc
The product contains undeclared Yellow 5 and 6, Blue 1, and unapproved Red 3.
May 27, 2026
H-1145-2026
Vanilla Dessert Shells (Giant), 6 dessert shells/1 package, 1 dessert shell is approximate
Recalled by Specialty Bakers, LLC
Undeclared Allergen (Soy)
May 27, 2026
H-1075-2026
azuma foods TAKO WASABI Seasoned Octopus with Wasabi PERISHABLE/KEEP FROZEN PRODUCT OF J
Recalled by Azuma Foods International Inc USA
Undeclared fish.
May 26, 2026
H-1111-2026
Roast beef and cheddar closed face sandwich packed in clear plastic wrap with a green adhe
Recalled by Produce Innovations
Incorrect Product Label; Roast Beef and Swiss closed face sub sandwich labeled as Turkey and Cheddar closed face sub san
May 23, 2026
H-1128-2026
MOGO PURE MORINGA OLEIFERA CAPSULES, HERBAL SUPPLEMENT, 180 QUICK RELEASE VEGGIE CAPSULE,
Recalled by MOGO Moringa LLC
Product may be contaminated with Salmonella Typhimurium
May 21, 2026
H-1133-2026
boichik bagles Pumpernickel Mix Bagels 6 pre-sliced bagels NET WT 26.5 OZ (1.66 LB) 750g
Recalled by Boichik Bagels, Inc.
Undeclared allergen, sesame.
💊 Drug Recalls
Jun 28, 2026
D-0661-2026
Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla
Recalled by Cipla USA, Inc.
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Jun 28, 2026
D-0676-2026
Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla
Recalled by Cipla USA, Inc.
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Jun 28, 2026
D-0675-2026
Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla
Recalled by Cipla USA, Inc.
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Jun 25, 2026
D-0660-2026
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate
Recalled by Lannett Company Inc.
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Jun 23, 2026
D-0672-2026
Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous
Recalled by Reliance Life Sciences Private Limited
Lack of Sterility Assurance
Jun 23, 2026
D-0673-2026
Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcut
Recalled by Reliance Life Sciences Private Limited
Lack of Sterility Assurance
Jun 23, 2026
D-0671-2026
Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous
Recalled by Reliance Life Sciences Private Limited
Lack of Sterility Assurance
Jun 23, 2026
D-0674-2026
Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneou
Recalled by Reliance Life Sciences Private Limited
Lack of Sterility Assurance
Jun 23, 2026
D-0664-2026
Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded dru
Recalled by QuVa Pharma, Inc.
Failed Impurities/Degradation Specifications
Jun 22, 2026
N/A
Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Dilu
Recalled by Lupin Pharmaceuticals Inc.
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing
Jun 21, 2026
D-0617-2026
DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps
Recalled by Direct Rx
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Jun 16, 2026
D-0628-2026
Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries
Recalled by SUN PHARMACEUTICAL INDUSTRIES INC
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablet
Jun 15, 2026
D-0609-2026
Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), R
Recalled by The Harvard Drug Group LLC
Subpotent Drug
Jun 11, 2026
D-0657-2026
Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets),
Recalled by Boehringer Ingelheim Pharmaceuticals, Inc.
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper
Jun 11, 2026
D-0596-2026
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx O
Recalled by Par Health USA, LLC
Crystallization; identified as Buprenorphine free base
Jun 10, 2026
D-0643-2026
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl
Recalled by CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and steri
Jun 10, 2026
D-0646-2026
ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcoh
Recalled by CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and steri
Jun 10, 2026
D-0652-2026
BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol)
Recalled by CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and steri
Jun 10, 2026
D-0651-2026
BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),
Recalled by CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and steri
Jun 10, 2026
D-0650-2026
BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alco
Recalled by CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and steri
🩺 Medical Device Recalls
Jun 15, 2026
Z-2644-2026
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer;
Recalled by Accuray Incorporated
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operat
Jun 15, 2026
Z-2640-2026
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer;
Recalled by Accuray Incorporated
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operat
Jun 8, 2026
Z-2717-2026
Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Cat
Recalled by CMR SURGICAL LIMITED
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.
Jun 8, 2026
Z-2674-2026
Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Sing
Recalled by Zimmer Surgical Inc
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection.
Jun 8, 2026
Z-2673-2026
Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual
Recalled by Zimmer Surgical Inc
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection.
Jun 7, 2026
Z-2677-2026
Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Recalled by ConvaTec, Inc
Surgical dressing manufactured out of specification (greater thickness).
Jun 7, 2026
Z-2699-2026
KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
Recalled by Klowen Braces
A product error defect may cause incorrect bracket placement.
Jun 7, 2026
Z-2703-2026
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Recalled by Siemens Healthcare Diagnostics, Inc.
The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which co
Jun 7, 2026
Z-2648-2026
ARTIS icono ceiling. Model Number: 11328100.
Recalled by Siemens Medical Solutions USA, Inc
Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws
Jun 4, 2026
Z-2676-2026
Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duoden
Recalled by Olympus Corporation of the Americas
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of t
Jun 4, 2026
Z-2645-2026
Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Numb
Recalled by Medela Inc
May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue
Jun 4, 2026
Z-2714-2026
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
Recalled by Integra LifeSciences Corp. (NeuroSciences)
The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identifie
Jun 4, 2026
Z-2579-2026
Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following syste
Recalled by Philips North America Llc
Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the eq
Jun 3, 2026
Z-2715-2026
VITEK 2 AST-N447 TEST KIT Product reference 424620
Recalled by Biomerieux Inc
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot
Jun 3, 2026
Z-2654-2026
MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461
Recalled by BD SWITZERLAND SARL
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
Jun 2, 2026
Z-2623-2026
GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
Recalled by Remel, Inc
Reduced or no recovery of some strains of Neisseria gonorrhoeae.
May 31, 2026
Z-2649-2026
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Recalled by Carl Zeiss Meditec AG
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
May 28, 2026
Z-2463-2026
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1,
Recalled by Hamilton Medical AG
Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectab
May 27, 2026
Z-2609-2026
Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG
Recalled by Medline Industries, LP
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involvi
May 27, 2026
Z-2607-2026
Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ9
Recalled by Medline Industries, LP
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involvi
Get email alerts for new FDA recalls
The FDA sends free email notifications whenever a new recall is issued. Sign up so you find out within hours, not weeks — especially important for prescription drugs and food allergens.
Subscribe at FDA.gov ↗What you can do
- Check the official FDA recall search at fda.gov/safety/recalls for the most current list.
- If you have a recalled product: stop using it, photograph the package + lot number for your records, and follow the return/refund instructions on the FDA enforcement record.
- For prescription drug recalls: do not stop a medication on your own — call your doctor or pharmacist first. They may swap to a different manufacturer's version of the same drug.
- For Class I food recalls: throw out the product. Don't donate it. Wipe down shelves and surfaces that touched it.
- Also check non-FDA recalls: USDA meat/poultry and CPSC consumer products (toys, appliances, etc.).
More health indicators