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Recalls affecting Michigan

Data last updated: September 9, 2026 at 1:18 PM UTC

17,010 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 9, 2025

Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18

CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.

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-0533-2025
Lot/product code:
Lot 23142117, 23142119, 23142122, Exp Date: May 2026; Lot 24142625, Exp Date: Jun. 2027
Recalling firm:
Ascend Laboratories, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 9, 2025

Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-885-04

Failed Dissolution 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-0546-2025
Lot/product code:
Lot #: 7715893A, Exp. Date 12/31/2027
Recalling firm:
Strides Pharma, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenUndeclaredRecalled July 8, 2025

Ritz Peanut Butter Cracker Sandwiches, Net Wt. 55.2 oz, 40 count (40x1.38 oz 6 pack of cracker sandwiches inside carton. 40 - 55.2oz Cartons in master carton. UPC 0 44000 07819 5

Not listed on the label allergens (Peanut) due to mispackaging

Full report

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

Recall #:
H-0324-2025
Lot/product code:
1 NOV 25 - 9 NOV 25 2 JAN 26 - 22 JAN 26
Recalling firm:
Mondelez Global Llc
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenUndeclaredRecalled July 8, 2025

Ritz Peanut Butter Cracker Sandwiches, Net Wt. 11.4 oz, 8 count (8x1.38 oz 6 pack of cracker sandwiches inside carton. 14X8-Case: 14 - 11.04 Oz Cartons in master carton. UPC 0 44000 88210 5

Not listed on the label allergens (Peanut) due to mispackaging

Full report

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

Recall #:
H-0326-2025
Lot/product code:
1 NOV 25 - 9 NOV 25 "AE" Plant Code Only
Recalling firm:
Mondelez Global Llc
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenUndeclaredRecalled July 8, 2025

Ritz Cracker Sandwiches, Variety 20 count variety Pack, (20- Packs of 10 Cheese 1.35 oz Packs and 10 Peanut Butter 1.38 oz Packs) Net Wt. 27.3 oz (20-1.38 oz packet of cracker sandwiches inside cartons of varying sizes). 20-27.3 OZ (Case: 6 - 27.3 Oz Cartons in master carton. UPC 0 44000 08095 2

Not listed on the label allergens (Peanut) due to mispackaging

Full report

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

Recall #:
H-0325-2025
Lot/product code:
2 NOV 25 - 9 NOV 25
Recalling firm:
Mondelez Global Llc
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodAllergenUndeclaredRecalled July 8, 2025

Ritz Peanut Butter Cracker Sandwiches, Net Wt.27.6 oz, 20 count (20x1.38 oz) 6- pack of cracker sandwiches inside cartons. And 6x20(6 - 27.6 oz Cartons) in master carton. UPC 1 00 44000 07584 2

Not listed on the label allergens (Peanut) due to mispackaging

Full report

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

Recall #:
H-0323-2025
Lot/product code:
1 NOV 25 - 9 NOV 25 2 JAN 26 - 22 JAN 26
Recalling firm:
Mondelez Global Llc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 7, 2025

RITE AID PHARMACY, first aid alcohol prep pads, DISTRIBUTED BY: RITE AID. 200 NEWBERRY COMMONS, ETTERS, PA 17319, NDC 11822-5156-2.

Weaker than it should be Drug- isopropyl alcohol levels fall below the labeled concentration.

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-0605-2025
Lot/product code:
61224070083
Recalling firm:
MEDLINE INDUSTRIES, LP - Northfield
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 7, 2025

CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30

Weaker than it should be Drug- isopropyl alcohol levels fall below the labeled concentration.

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-0601-2025
Lot/product code:
61224050002
Recalling firm:
MEDLINE INDUSTRIES, LP - Northfield
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 7, 2025

ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walmart, Inc., Bentonville, AR 72716 Walmart: 200 eaches per box, 24 boxes per case (4,800 eaches per case), NDC 49035-814-60.

Weaker than it should be Drug- isopropyl alcohol levels fall below the labeled concentration.

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-0602-2025
Lot/product code:
61224070073
Recalling firm:
MEDLINE INDUSTRIES, LP - Northfield
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 7, 2025

Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen, 1 West First Avenue, Conshohocken, PA 19428, Made in China: 100 eaches per box, 30 boxes per case, (3,000 eaches per case), NDC 46122-043-78.

Weaker than it should be Drug- isopropyl alcohol levels fall below the labeled concentration.

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-0604-2025
Lot/product code:
61224070074
Recalling firm:
MEDLINE INDUSTRIES, LP - Northfield
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 7, 2025

Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30.

Weaker than it should be Drug- isopropyl alcohol levels fall below the labeled concentration.

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-0600-2025
Lot/product code:
61224040057
Recalling firm:
MEDLINE INDUSTRIES, LP - Northfield
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 7, 2025

H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with components from Taiwan, Elaborado Con Orgullo Y Cuidado PARA H-E-B, San Antonio, TX 78204, NDC 37808-809-09.

Weaker than it should be Drug- isopropyl alcohol levels fall below the labeled concentration.

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-0603-2025
Lot/product code:
61224080041
Recalling firm:
MEDLINE INDUSTRIES, LP - Northfield
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled July 5, 2025

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.

Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.

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-0543-2025
Lot/product code:
Lot#: 083L061, Exp.: 11/2025.
Recalling firm:
FDC Limited
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 30, 2025

Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC# 69097-319-86 (pouch), 69097-319-87 (carton)

Not guaranteed to be germ-free: A market complaint was received for leakage and empty ampoule.

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-0541-2025
Lot/product code:
Batch # 4IA0505, Exp 09/31/2026
Recalling firm:
Cipla USA, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 30, 2025

Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

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-0511-2025
Lot/product code:
Lot # 230199, Exp. Date 01/31/2026
Recalling firm:
Breckenridge Pharmaceutical, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 30, 2025

Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10

Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole 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-0525-2025
Lot/product code:
Lot: C2403017, Exp 12/31/2026
Recalling firm:
Dr. Reddy's Laboratories, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 24, 2025

Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, Hyderadab-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151,

Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.

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-0510-2025
Lot/product code:
Lot # a)1400008A, Exp Date: 12/31/2025; b) 1400008B, Exp Date: 12/31/2025
Recalling firm:
Granules Pharmaceuticals Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 20, 2025

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-15

Weaker than it should be Drug: Assay below the approved specification

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-0518-2025
Lot/product code:
Lot #D2300325, Exp Date: 01/31/2026; Lot #D2400536, Exp Date: 02/28/2026
Recalling firm:
ACCORD HEALTHCARE, INC.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 20, 2025

Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA, NDC 68180-519-01

Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.

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-0532-2025
Lot/product code:
Lot #: QA01081, Exp. Date April 2027
Recalling firm:
Lupin Pharmaceuticals Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 20, 2025

Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-452-17

Weaker than it should be Drug: Assay below the approved specification

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-0522-2025
Lot/product code:
Lot #D2300104, Exp Date: 12/31/2025
Recalling firm:
ACCORD HEALTHCARE, INC.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 20, 2025

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17

Weaker than it should be Drug: Assay below the approved specification

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-0519-2025
Lot/product code:
Lot #D2400679, Exp Date: 02/28/2026
Recalling firm:
ACCORD HEALTHCARE, INC.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 20, 2025

Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-456-17

Weaker than it should be Drug: Assay below the approved specification

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-0524-2025
Lot/product code:
Lot #D2300042, Exp Date: 12/31/2025
Recalling firm:
ACCORD HEALTHCARE, INC.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 20, 2025

Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17

Weaker than it should be Drug: Assay below the approved specification

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-0523-2025
Lot/product code:
Lot #D2300076, Exp Date: 12/31/2025
Recalling firm:
ACCORD HEALTHCARE, INC.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 20, 2025

Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-15

Weaker than it should be Drug: Assay below the approved specification

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-0520-2025
Lot/product code:
Lot #D2300087, Exp Date: 12/31/2025
Recalling firm:
ACCORD HEALTHCARE, INC.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 20, 2025

Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-451-17

Weaker than it should be Drug: Assay below the approved specification

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-0521-2025
Lot/product code:
Lot #D2300092, Exp Date: 12/31/2025; Lot #D2400722, Exp Date: 03/31/2026
Recalling firm:
ACCORD HEALTHCARE, INC.
View official FDA record (opens in a new tab)