Montana 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
May 7, 2026
H-0854-2026
Fly By Jing (branded) Creamy Sesame Noodles; 3.8 oz packets. Sold in single and 4 packs. S
Recalled by Fly By Jing Inc.
Possible cross-contamination resulting in undeclared allergen ingredient (Peanut)
May 6, 2026
H-0809-2026
Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement, Net Wt. 8 FL Oz (237mL) Ambe
Recalled by Llorens Pharmaceuticals International Division, Inc.
Foreign object: black particulate matter
May 4, 2026
H-0835-2026
Good & Gather Mexican Street Corn Trail Mix 8 oz bag UPC 085239270240, 8 bags per case
Recalled by JOHN B SANFILIPPO & SONS INC
potential presence of Salmonella
May 4, 2026
H-0850-2026
Butter Parsley Bagel Crisps, Item Number 18490, Net Weight: 10 lbs. Legacy Bakehouse, LL
Recalled by Legacy Bakehouse LLC
Products were made with recalled California Dairies milk powder due to Salmonella.
May 4, 2026
H-0836-2026
Fisher Tex Mex Trail Mix 30 oz plastic jar UPC 070690275941, 6 jars per case
Recalled by JOHN B SANFILIPPO & SONS INC
potential presence of Salmonella
May 4, 2026
H-0834-2026
Squirrel Brand Town & Country Mix 16 oz can UPC 07223805251 and 7.5 oz can UPC 07223805450
Recalled by JOHN B SANFILIPPO & SONS INC
potential presence of Salmonella
May 4, 2026
H-0831-2026
Southern Style Nuts Gourmet Hunter Mix 23 oz plastic jar UPC 085839073319 and 36 oz plasti
Recalled by JOHN B SANFILIPPO & SONS INC
potential presence of Salmonella
May 4, 2026
H-0832-2026
Southern Style Nuts Hunter Mix 30 oz plastic jar UPC 085839916302, 4 jars per case
Recalled by JOHN B SANFILIPPO & SONS INC
potential presence of Salmonella
May 4, 2026
H-0848-2026
Stoltzfus Family Farm Sour Cream and Onion cheese curds, 8-ounce
Recalled by Stoltzfus Family Dairy LLC
Product may be contaminated with Salmonella.
May 4, 2026
H-0852-2026
giant eagle Baked Pita Chips with Parmesan, Garlic & Herb Bagel Crisps, Net Wt 7.33 oz.
Recalled by Legacy Bakehouse LLC
Products were made with recalled California Dairies milk powder due to Salmonella.
May 4, 2026
H-0851-2026
Parmesan & Herb Bagel Crisps, Item Number 18139, Net Weight: 10 lbs. Legacy Bakehouse, L
Recalled by Legacy Bakehouse LLC
Products were made with recalled California Dairies milk powder due to Salmonella.
May 4, 2026
H-0833-2026
Squirrel Brand Travelers Mix 16 oz can UPC 07223899166, 12 cans per case
Recalled by JOHN B SANFILIPPO & SONS INC
potential presence of Salmonella
Apr 30, 2026
H-0780-2026
...And Kimchi branded kimchi; packaged in 3 sizes of glass containers (126oz, 63oz, 30oz);
Recalled by Ocinet, Inc.
Undeclared allergen ingredient (fish)
Apr 27, 2026
H-0779-2026
Prospector Popcorn brand Belgian Chocolate Toffee flavored popcorn; Ingredients: Non-GMO p
Recalled by Prospector Popcorn, LLC
Products contain undeclared soy, specifically soy lecithin.
Apr 27, 2026
H-0810-2026
MA Cohen's Kippered Herring vacuum packed, weight provided at retail, UPC 7232577992
Recalled by Shining Sea Fish Co. LLC
Clostridium botulinum is an uncontrolled hazard
Apr 26, 2026
H-0781-2026
Kroger HOMESTYLE Cheese AND Garlic CROUTONS NET WT 5 OZ (141g) UPC 0 11110 81353 4 DISTRIB
Recalled by Sugar Foods LLC
Possible Salmonella in croutons. The firm was notified by their supplier that the non-fat milk powder used to manufactur
Apr 25, 2026
H-0844-2026
GHIRARDELLI SWEET GROUND POWDER WHITE CHOCOLATE FLAVORED NET WT 50oz (3lbs 2oz) 1.41kg Di
Recalled by Ghirardelli Chocolate Company
Potential contamination with Salmonella.
Apr 25, 2026
H-0838-2026
GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX FROZEN HOT COCOA NET WT 50oz (3lbs 2oz) 1.42kg In
Recalled by Ghirardelli Chocolate Company
Potential contamination with Salmonella.
Apr 25, 2026
H-0840-2026
GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX WHITE MOCHA NET WT 50oz (3lbs 2oz) 1.42kg Ingredi
Recalled by Ghirardelli Chocolate Company
Potential contamination with Salmonella.
Apr 25, 2026
H-0845-2026
GHIRARDELLI SWEET GROUND POWDER CHOCOLATE & COCOA NET WT 48oz (3lbs) 1.36kg Distributed b
Recalled by Ghirardelli Chocolate Company
Potential contamination with Salmonella.
Apr 25, 2026
H-0843-2026
GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX VANILLA NET WT 48oz (3lbs) 1.36kg Ingredients: **
Recalled by Ghirardelli Chocolate Company
Potential contamination with Salmonella.
Apr 25, 2026
H-0842-2026
GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX CHOCOLATE FLAVORED NET WT 50oz (3lbs 2oz) 1.42kg
Recalled by Ghirardelli Chocolate Company
Potential contamination with Salmonella.
Apr 25, 2026
H-0847-2026
GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX CLASSIC WHITE NET WT 50oz (3lbs 2oz) 1.42kg Ingre
Recalled by Ghirardelli Chocolate Company
Potential contamination with Salmonella.
Apr 25, 2026
H-0839-2026
GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX MOCHA NET WT 50oz (3lbs 2oz) 1.42kg Ingredients:
Recalled by Ghirardelli Chocolate Company
Potential contamination with Salmonella.
Apr 25, 2026
H-0846-2026
GHIRARDELLI PREMIUM HOT COCOA MIX NET WT 32oz (2lbs) 907g Ingredients: *** nonfat dry milk
Recalled by Ghirardelli Chocolate Company
Potential contamination with Salmonella.
💊 Drug Recalls
May 17, 2026
D-0551-2026
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only
Recalled by AbbVie Inc.
Failed Stability Specifications
May 13, 2026
D-0550-2026
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY
Recalled by AVEVA Drug Delivery Systems, Inc.
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life spec
May 11, 2026
D-0548-2026
fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDos
Recalled by IntegraDose Compounding Services LLC
Subpotent Drug
May 11, 2026
D-0543-2026
Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distribut
Recalled by ANI Pharmaceuticals, Inc.
Defective Container; packets were found to be either empty or partially full.
May 10, 2026
D-0542-2026
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059
Recalled by Haleon US Holdings LLC
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
May 7, 2026
D-0546-2026
cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manuf
Recalled by UCB Biosciences Inc.
Lack of Assurance of Sterility
May 3, 2026
D-0539-2026
Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd
Recalled by Sagent Pharmaceuticals
Failed Impurities/Degradation Specifications
Apr 30, 2026
D-0537-2026
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only
Recalled by Amerisource Health Services LLC
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Apr 30, 2026
D-0536-2026
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx onl
Recalled by Amerisource Health Services LLC
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Apr 30, 2026
D-0549-2026
Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic
Recalled by Safecor Health, LLC
Presence of a Foreign Substance; black particles observed in liquid
Apr 29, 2026
D-0538-2026
Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in car
Recalled by Safecor Health, LLC
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Apr 28, 2026
D-0545-2026
Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus
Recalled by Zydus Pharmaceuticals (USA) Inc
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Apr 28, 2026
D-0514-2026
Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b)
Recalled by Ajanta Pharma Ltd.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12
Apr 28, 2026
D-0544-2026
Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus
Recalled by Zydus Pharmaceuticals (USA) Inc
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Apr 28, 2026
D-0516-2026
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Phar
Recalled by Ajanta Pharma Ltd.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12
Apr 28, 2026
D-0515-2026
Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Phar
Recalled by Ajanta Pharma Ltd.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12
Apr 27, 2026
D-0540-2026
Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethl
Recalled by B BRAUN MEDICAL INC
Presence of Particulate Matter.
Apr 26, 2026
D-0525-2026
Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Ma
Recalled by Oasis Medical, Inc.
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations
Apr 26, 2026
D-0534-2026
Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company,
Recalled by Golden State Medical Supply Inc.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Apr 26, 2026
D-0535-2026
Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Compan
Recalled by Golden State Medical Supply Inc.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
🩺 Medical Device Recalls
May 12, 2026
Z-2240-2026
Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, elec
Recalled by Medtronic Neuromodulation
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
May 12, 2026
Z-2241-2026
Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, elec
Recalled by Medtronic Neuromodulation
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
Apr 29, 2026
Z-2258-2026
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), A
Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age
Apr 29, 2026
Z-2259-2026
Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010,
Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age
Apr 27, 2026
Z-2227-2026
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3
Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrad
Apr 27, 2026
Z-2225-2026
Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the
Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted d
Apr 27, 2026
Z-2229-2026
Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpa
Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrad
Apr 27, 2026
Z-2228-2026
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura
Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrad
Apr 23, 2026
Z-2246-2026
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-
Recalled by GE Medical Systems Information Technologies Inc
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPr
Apr 23, 2026
Z-2247-2026
GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in con
Recalled by GE Medical Systems Information Technologies Inc
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPr
Apr 23, 2026
Z-2245-2026
GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product
Recalled by GE Medical Systems Information Technologies Inc
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPr
Apr 23, 2026
Z-2239-2026
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Recalled by Devicor Medical Products Inc
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Mark
Apr 23, 2026
Z-2244-2026
GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code
Recalled by GE Medical Systems Information Technologies Inc
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPr
Apr 23, 2026
Z-2243-2026
GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by G
Recalled by GE Medical Systems Information Technologies Inc
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPr
Apr 23, 2026
Z-2242-2026
GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9;
Recalled by GE Medical Systems Information Technologies Inc
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPr
Apr 22, 2026
Z-2213-2026
OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107
Recalled by Novapproach Spine, LLC
Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an
Apr 22, 2026
Z-2226-2026
Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 3
Recalled by C.R. Bard Inc
Due to stain present on the surface of affected foley catheters.
Apr 21, 2026
Z-2067-2026
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.
Recalled by BioFire Diagnostics, LLC
Contamination to in-vitro diagnostic test may result in false positives.
Apr 21, 2026
Z-2160-2026
RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U
Recalled by Bolton Medical Inc.
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from b
Apr 20, 2026
Z-2218-2026
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardi
Recalled by Medtronic Perfusion Systems
Certain lots of product have the potential for a sterile barrier breach.
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.).
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