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Recalls affecting Massachusetts

Data last updated: September 7, 2026 at 12:15 AM UTC

16,837 recalls found

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded
UnclassifiedUndeclaredAnnounced September 4, 2026

Business Pill, Branch Manager for Mendietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced September 4, 2026

Foods AliveMoringa Leaf Powder

Potential to be contaminated with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

Full report
Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced September 3, 2026

Great ValueOrganic Triple Berry Blend

Possible E. Coli Contamination

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc.Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

Full report
Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

LipofitLipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

KofinasGarlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenUndeclaredAnnounced August 31, 2026

Little TemptationsChocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced August 29, 2026

Everything SproutsRobust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusAnnounced August 29, 2026

MartinaMangoes

Potential contamination with Salmonella

Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
Class IIModerate risk
DrugRecalled July 13, 2026

Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3559-0; NDC Blister: 0904-6950-61

Weaker than it should be Drug

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0708-2026
Lot/product code:
Bag lot #: N02200A, N02200B, Exp. Date 10/2026; Blister lot #: N02200, Exp. Date 10/2026
Recalling firm:
Major Pharmaceuticals
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 13, 2026

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6949-61

Weaker than it should be Drug

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0700-2026
Lot/product code:
Lot#: N02212, Exp. Date 07/2026
Recalling firm:
Major Pharmaceuticals
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 13, 2026

Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6951-61

Weaker than it should be Drug

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0702-2026
Lot/product code:
Lot# N02172, exp 07/2026; N02296, N02288, Exp. Date 12/2026
Recalling firm:
Major Pharmaceuticals
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 13, 2026

Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3562-0; NDC Blister: 0904-6951-61

Weaker than it should be Drug

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0710-2026
Lot/product code:
Bag lot #: N02266A, N02266B, Exp. Date 11/2026; Blister lot #: N02266, Exp. Date 11/2026
Recalling firm:
Major Pharmaceuticals
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 9, 2026

BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31

Not guaranteed to be germ-free: Affected product may exhibit an open or incomplete seal on the packaging of the applicator

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0690-2026
Lot/product code:
Lots: 4062535, 4065201, 4066446, Exp. 2/28/2027; 4141090, Exp. 5/31/2027; 4180288, 4197695, 4197697, 4180291, Exp. 6/30/2027; 4219454, 4221945, 4221966, 4222853, 4224361, Exp. 7/31/2027; 4228482, 4248656, 4249026, 4248961, 4249818, 4250729, Exp. 8/31/2027; 5124984, 5127231, 5129058, 5126398, 5129488, Exp. 4/30/2028; 5130576, 5142947, 5147432, 5154673, 5154671, 5156442, 5157968, 5158031, 5150160, 5155824, Exp. 5/31/2028; 5176326, 5181676, 5181074, 5182660, 5188102, 5188103, Exp. 6/30/2028; 5195818, 5199118, 5209474, 5210853, 5211985, 5211907, 5211212, Exp. 7/31/2028; 5226576, 5227151, 5230531, 5241733, 5242057, 5243430, 5246952, 5248375, 5248189, Exp. 8/31/2028; 5254509, 5274692, 5276968, 5279226, 5280240, Exp. 9/30/2028; 5305661, 5307185, 5309623, 5310701, Exp. 10/31/2028; 5346128, 5350797, Exp. 12/31/2028; 6031034, 6031234, 6037918, Exp. 1/31/2029; 6051588, 6054213, 6062168, 6063361, Exp. 2/28/2029; 6069891, Exp. 3/31/2029; 6111107, Exp. 4/30/2029.
Recalling firm:
CareFusion 213, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 8, 2026

Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500-30

Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0712-2026
Lot/product code:
Lot 25121311, expiry 3/31/2028
Recalling firm:
Ascend Laboratories, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 6, 2026

CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611-10.

Not guaranteed to be germ-free

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0689-2026
Lot/product code:
Lot #: 1239521, 1237454, Exp. Date 10/2027
Recalling firm:
Chiesi USA, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 2, 2026

Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00 (vial label) & NDC 67457-386-81 (carton label).

Presence of precipitate

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0734-2026
Lot/product code:
Lot #: 3241653, Exp 4/30/2027
Recalling firm:
MYLAN PHARMACEUTICALS INC
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled July 1, 2026

Mellish Island Super Skin; Dietary Supplement; 60 Capsules, 2 per day; Distributed by Mellish Island Corp. UPC: 8 58792 00332 3

Firm's finished product label does not declare the source of marine collagen which was determined to be fish.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
H-1190-2026
Lot/product code:
Lot: CA1G24 Expiration: 08-2027
Recalling firm:
Mellish Island Corp
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled July 1, 2026

Ultimate Mother's Day Wangshin Doenjang Aged 3 Years 9 oz. Korean Traditional Premium Soybean Paste UPC: 8 809897 940169

Product label allergen "contains" statement does not include anchovy(fish)

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
H-1221-2026
Lot/product code:
No Lot Codes Used Best by dates: March 28, 2027, June 01, 2027, August 15, 2027, August 25, 2027 and October 15, 2027
Recalling firm:
JINA F&C
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 29, 2026

Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-410-02

CGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0661-2026
Lot/product code:
Lot #: 5PB0465, 5PB0466, 5PB0557, Exp 4/30/2027; 5PB0629, 5PB0630, 5PB0633, 5PB0637, 5PB0638, Exp 6/30/2027
Recalling firm:
Cipla USA, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 29, 2026

Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-411-02

CGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0675-2026
Lot/product code:
Lot #: 5PB0165, 5PB0166, Exp 1/31/2027; 5PB0552, Exp 4/30/2027; 5PB0642, 5PB0643, 5PB0644, Exp 6/30/2027
Recalling firm:
Cipla USA, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 29, 2026

Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-412-02

CGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0676-2026
Lot/product code:
Lot #: 5PB0563, Exp 4/30/2027
Recalling firm:
Cipla USA, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 26, 2026

Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, Made in India, NDC 69452-435-30.

Presence of Foreign Tablets/Capsules

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0742-2026
Lot/product code:
Lot# 704C003, Exp. 12/31/2028
Recalling firm:
Bionpharma Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 26, 2026

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, Rx Only, 100 capsules, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC: 0527-0790-37.

Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0660-2026
Lot/product code:
Lot#: 25285401A, Exp. Date: 04/2027
Recalling firm:
Lannett Company Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 25, 2026

Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141.

Weaker than it should be Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0686-2026
Lot/product code:
Lot:1505161, 1505181, 1505301, 1505382, exp 2027-04.
Recalling firm:
Bell Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 25, 2026

CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895,

Weaker than it should be Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0678-2026
Lot/product code:
Lot: a) 1505121, 1504242, exp 2027-03; 1505132, 1505182, 1505191, 1505291, 1505331, exp 2027-04; b) 1504231, 1504311, exp 2027-03; 1505312, 1505321, exp 2027-04.
Recalling firm:
Bell Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 25, 2026

meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.

Weaker than it should be Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0687-2026
Lot/product code:
Lot:1505344, exp 2027-04.
Recalling firm:
Bell Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 25, 2026

FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01), DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320.

Weaker than it should be Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0683-2026
Lot/product code:
Lot: 1505124, 1505311, 1505332, expires: 2027-04.
Recalling firm:
Bell Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 25, 2026

AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005.

Weaker than it should be Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0682-2026
Lot/product code:
Lot: a)1505123, expires: 2027-04; b) 1505131, expires: 2027-04.
Recalling firm:
Bell Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 25, 2026

QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16), Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376.

Weaker than it should be Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0680-2026
Lot/product code:
Lot: a) 1505121, 1505342, exp 2027-04; b) 1505381, exp 2027-04.
Recalling firm:
Bell Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 25, 2026

CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785.

Weaker than it should be Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0688-2026
Lot/product code:
Lot:1505141, exp 2027-04.
Recalling firm:
Bell Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 25, 2026

LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017.

Weaker than it should be Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0685-2026
Lot/product code:
Lot: a) 1505333, expires: 2027-04; b) 1505144, 1505302, expires: 2027-04.
Recalling firm:
Bell Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 25, 2026

TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007.

Weaker than it should be Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0681-2026
Lot/product code:
Lot: a) 1505122, 1505343, expires: 2027-04; b) 1505142, 1505341, expires: 2027-04.
Recalling firm:
Bell Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 25, 2026

GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428.

Weaker than it should be Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

ALL 50 STATES
Full report

A moderate-risk recall. Using this product might cause temporary or reversible health problems, and serious harm is unlikely.

Recall #:
D-0684-2026
Lot/product code:
Lot: a) 1505334, expires: 2027-04; b) 1505143, 1505151, expires: 2027-04
Recalling firm:
Bell Pharmaceuticals, Inc
View official FDA record (opens in a new tab)