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Recalls affecting Delaware

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

16,320 recalls found
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Just announced

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

Business Pill, Branch Manager for Men — dietary 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/virusSalmonellaAnnounced September 4, 2026

Foods Alive — Moringa 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. Braun — 0.9% 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/virusE. coliAnnounced September 3, 2026

Great Value — Organic 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

Lipofit — Lipofit 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

Kofinas — Garlic 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)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey 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/virusSalmonellaE. coliAnnounced August 29, 2026

Everything Sprouts — Robust 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/virusSalmonellaAnnounced August 29, 2026

Martina — Mangoes

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
DrugChemicalRecalled February 13, 2025

Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%), packaged in 3 OZ spray bottles, Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403, UPC 813277019923 and UPC 813277019916

Chemical Contamination

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-0276-2025
Lot/product code:
UPC 813277019916 Lot #: A033 / 5880343A, A054 / 2030633A, A058 / 2050633A, A058 / 2050633B, A058 / 2060633A, A058 / 2070633A, A058 / 2040633A, A059 / 2080633A, Exp. Date Feb-25; A314 / 4513223A, Exp. Date Nov-25; C054 / 2090774A, C057 / 2100774A, Exp. Date Feb-26; C131 / 3201394A, C131 / 3211394A, C131 / 3211394B, C131 / 3211394C, Exp. Date May-26 UPC 813277019923 Lot #: A060 / 3780693A, A060 / 3780693B, Exp. Date Mar-25; C067 / 2110774A, C067 / 2110774B, C067 / 2110774C, Exp. Date Mar-26; C169 / 7921734A, C169 / 7921734B, Exp. Date Jun-26
Recalling firm:
Johnson, S C and Son, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 13, 2025

Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1839-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ

Failed Impurities/Degradation 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-0256-2025
Lot/product code:
Lot: a) P300197, Exp. Aug-2025; P400113, Exp. May-26; b) P300169, Exp. Jun-2025; P400115, Exp. May-2026.
Recalling firm:
Zydus Pharmaceuticals (USA) Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugChemicalRecalled February 13, 2025

Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%) packaged in a) 6 OZ (170 g) spray bottles UPC 813277019954 and UPC 813277019800; and b) Twinpack UPC 813277019930; Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403.

Chemical Contamination

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-0275-2025
Lot/product code:
a) UPC 813277019954 Lot #: A034 / 5810343A, A034 / 5820343A, Exp. Date Feb-25; A282 / 0122853A, A289 / 0132853A, Exp. Date Oct-25; C010 / 1680174A, C011 / 1690174A, Exp. Date Jan-26; C218 / 2592224A, C218 / 2602224A, Exp. Date Aug-26. UPC 813277019800 Lot #: A142 / 3901443A, A142 / 3911443A, A142 / 3921443A, Exp. Date May-25; A278 / 0142843A, A279 / 0152843A, A279 / 0162843A, Exp. Date Oct-25; A314 / 4473263A, A314 / 4483263A, A317 / 4493263A, Exp. Date Nov-25; C046 / 0100594A, C047 / 0110594A C050 / 0120594A, Exp. Date Feb-26; C068 / 2770774A, C071 / 2790774A, Exp. Date Mar-26; C102 / 9621154A, C102 / 9621154B, C102 / 9621154C, Exp. Date Apr-26; C144 / 4721534A, C144 / 4731534A, C144 / 4741534A, C144 / 4751534A, Exp. Date May-26 b) UPC 813277019930 Lot #: A033 / 5830343A, Exp. Date Feb-25; A079 / 9620893A, A079 / 9630893A, Exp. Date Mar-25; A142 / 3881453A, A142 / 3891453A, Exp. Date May-25
Recalling firm:
Johnson, S C and Son, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 13, 2025

Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1726-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ

Failed Impurities/Degradation 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-0255-2025
Lot/product code:
Lot: a) P300072, P300073 Exp. Feb-2025; P300153, Exp. Jun-25; P300195, Exp. Aug-2025; P400014, P400017, Exp. Dec-2025; P400070, Exp. Feb-2026; P400112, May-2026; P400142, Exp. Jul-2026; b) P300068, Exp. Feb-2025; P300154, Exp.Jun-2025; P400015, P400018, Exp. Dec-2025; P400068, Exp. Feb-2026; P400114, Exp. May-2026; P400139, Exp.Jul-2026.
Recalling firm:
Zydus Pharmaceuticals (USA) Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 6, 2025

Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30

Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.

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-0246-2025
Lot/product code:
Lot # 193109; Exp. 07/31/2026
Recalling firm:
Padagis US LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 6, 2025

Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901. Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 63304-452-01

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-0249-2025
Lot/product code:
Lot #: AD16615, Exp. Date 07/2025
Recalling firm:
SUN PHARMACEUTICAL INDUSTRIES INC
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodBacteria/virusBotulismRecalled February 4, 2025

Trader Joe's branded Solid White Albacore Tuna in olive oil; NET WT. 5 OZ (142g) DR WT. 4 OZ (113g); Dist & Sold Exclusively By: Trader Joe's, Monrovia, CA 91816; UPC# 99287

Product's easy-pull lid was not secured properly and may cause the product to become contaminated or improperly processed with the hazard clostridium botulinum.

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 #:
F-0615-2025
Lot/product code:
Best By dates: 01/13/2028 Lots: S84ND3N; S94ND4N
Recalling firm:
Chicken of the Sea; Thai Union
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 4, 2025

Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals of NY, LLC, NY 11719, NDC 42291-778-90

Weaker than it should be Drug: not meeting quality requirements (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)

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-0229-2025
Lot/product code:
Lot#: BC20223A, Exp. March 31, 2025.
Recalling firm:
AvKARE
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodBacteria/virusBotulismRecalled February 4, 2025

Trader Joe's branded Solid White Albacore Tuna in Water, salt added; NET WT. 5 OZ (142g) DR WT. 4 OZ (113g); Dist & Sold Exclusively By: Trader Joe's, Monrovia, CA 91816; UPC# 0099285

Product's easy-pull lid was not secured properly and may cause the product to become contaminated or improperly processed with the hazard clostridium botulinum.

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 #:
F-0613-2025
Lot/product code:
Best By dates: 01/09/2028; 01/10/2028 Lots: S92ND1L; S92ND2L
Recalling firm:
Chicken of the Sea; Thai Union
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodBacteria/virusBotulismRecalled February 4, 2025

Genova branded Yellowfin Tuna; Genova; In Olive Oil; Wild Caught; NET WT. 5 OZ (142g) RD WT. 4 OZ (113g); Distributed by Tri-Union Seafoods, LLC.; El Sugundo, CA 90245 U.S.A. UPC# 48000 73265 UPC# 48000 13265 UPC# 48000 63267 Product is packaged in several different configurations. shrink wrapped 4- 5 ounce can pack. flat of 24- 5 ounce individual cans. Shrink wrapped 6- 7 ounce can pack.

Product's easy-pull lid was not secured properly and may cause the product to become contaminated or improperly processed with the hazard clostridium botulinum.

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 #:
F-0611-2025
Lot/product code:
Best By dates: 12/13/2027; 1/13/2028; 01/17/2028; 01/21/2028; 01/23/2028; 01/24/2028; 01/27/2028 Lots: S84N D1N; S84N D2M; S84N 41M; S84N 42M; S84N 42N; S84N 43N; S84N D1L; S84N D3L; S84N D1D; S84N D3D; S84N D2D
Recalling firm:
Chicken of the Sea; Thai Union
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodBacteria/virusBotulismRecalled February 4, 2025

Trader Joe's branded Solid White Albacore Tuna in water, Low sodium; NET WT. 5 OZ (142g) DR WT. 4 OZ (113g); Dist & Sold Exclusively By: Trader Joe's, Monrovia, CA 91816; UPC# 95836

Product's easy-pull lid was not secured properly and may cause the product to become contaminated or improperly processed with the hazard clostridium botulinum.

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 #:
F-0618-2025
Lot/product code:
Best By dates: 12/12/2027; 12/13/2027 Lots: S91N 41K; S91N 43M; S91N 44M
Recalling firm:
Chicken of the Sea; Thai Union
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodBacteria/virusBotulismRecalled February 4, 2025

Trader Joe's branded Solid White Albacore Tuna in Water, no salt added; NET WT. 5 OZ (142g) DR WT. 4 OZ (113g); Dist & Sold Exclusively By: Trader Joe's, Monrovia, CA 91816; UPC# 0099 2848

Product's easy-pull lid was not secured properly and may cause the product to become contaminated or improperly processed with the hazard clostridium botulinum.

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 #:
F-0612-2025
Lot/product code:
Best By dates: 01/08/2028; 01/09/2028 Lots: S90ND2N; S90ND1M; S90ND2N
Recalling firm:
Chicken of the Sea; Thai Union
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodBacteria/virusBotulismRecalled February 4, 2025

HEB branded Solid White Albacore Tuna in water; Wild Caught; NET WT. 5 OZ (142g) DR WT. 4 OZ (113g); Made with Pride and Care for H-E-B, San Antonio, TX 78204 UPC# 41220 14184 (can); UPC# 41220 43345 (4 pack shrink pack) Chunk White Albacore Tuna in water; wild caught; NET WT. 5 OZ (142g) DR WT. 4 OZ (113g); Made with Pride and Care for H-E-B, San Antonio, TX 78204 UPC# 41220 14205 (can); UPC# 41220 24585 (4 pack shrink pack)

Product's easy-pull lid was not secured properly and may cause the product to become contaminated or improperly processed with the hazard clostridium botulinum.

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 #:
F-0616-2025
Lot/product code:
Best By dates: 12/12/2027 Lots: S9FA45K; S9FA46K
Recalling firm:
Chicken of the Sea; Thai Union
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodBacteria/virusBotulismRecalled February 4, 2025

Genova branded Yellowfin Tuna in Extra Virgin Olive Oil and Sea Salt; NET WT. 5 OZ (142g) RD WT. 4 OZ (113g); Distributed by Tri-Union Seafoods, LLC.; El Sugundo, CA 90245 U.S.A. UPC# 48000 13275

Product's easy-pull lid was not secured properly and may cause the product to become contaminated or improperly processed with the hazard clostridium botulinum.

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 #:
F-0617-2025
Lot/product code:
Best By dates: 01/17/2028 Lots: S88N D1M
Recalling firm:
Chicken of the Sea; Thai Union
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodBacteria/virusBotulismRecalled February 4, 2025

Van Camp's branded Solid Light Yellowfin in Vegetable oil; NET WT. 5 OZ (142g) DR WT. 4 OZ (113g); Distributed by: Chicken of The Sea Intl.; El Segundo, CA 90245 U.S.A. UPC# 48000 25015 UPC# 48000 75015

Product's easy-pull lid was not secured properly and may cause the product to become contaminated or improperly processed with the hazard clostridium botulinum.

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 #:
F-0619-2025
Lot/product code:
Best By dates: 12/02/2027 Lots: S83N 45K
Recalling firm:
Chicken of the Sea; Thai Union
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodBacteria/virusBotulismRecalled February 4, 2025

Trader Joe's branded Solid Light Yellowfin Tuna in olive oil, Pole & Line Caught; NET WT. 5 OZ (142g) DR WT. 4 OZ (113g); Dist & Sold Exclusively By: Trader Joe's, Monrovia, CA 91816; UPC# 51403

Product's easy-pull lid was not secured properly and may cause the product to become contaminated or improperly processed with the hazard clostridium botulinum.

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 #:
F-0614-2025
Lot/product code:
Best By dates: 01/10/2028 Lots: S74ND2M
Recalling firm:
Chicken of the Sea; Thai Union
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodBacteria/virusBotulismRecalled February 4, 2025

Genova branded Solid white Tuna; In Olive Oil; Wild Caught; NET WT. 5 OZ (142g) RD WT. 4 OZ (113g); Distributed by Tri-Union Seafoods, LLC.; El Sugundo, CA 90245 U.S.A. UPC# 48000 00215,

Product's easy-pull lid was not secured properly and may cause the product to become contaminated or improperly processed with the hazard clostridium botulinum.

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 #:
F-0610-2025
Lot/product code:
Best By dates: 12/12/2027, 01/24/2028 Lots: S94N 42K; S94N 43K; S94N 44K; S94N D1L flat of 24- 5 ounce individual cans: 01/13/2028 ;01/17/2028; 01/24/2028; 12/12/2027; 01/21/2028; 01/27/2028 Lots: S84ND1N; S84ND2M; S84ND4H; S88ND1M; S94N42K; S94N43K; S94N44K; S94ND1M; S94ND1L Shrink wrapped 6- 7 ounce can pack: 01/21/2028; 01/23/2028; 01/27/2028 Lots: S84ND1D; S84ND3D; S84ND2D
Recalling firm:
Chicken of the Sea; Thai Union
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 30, 2025

Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. Made in India. Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152. NDC: 0904-7216-61

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-0221-2025
Lot/product code:
Lot# T05224; Exp. 02/2026
Recalling firm:
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 29, 2025

Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01.

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended 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-0242-2025
Lot/product code:
Lot Numbers: 19234630, Exp.: 10/2025; 19240529, Exp.: 1/2026.
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 29, 2025

Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30.

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended 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-0235-2025
Lot/product code:
Lot Numbers: 19234630, Exp.: 10/2025; 19240528, 19240529, Exp.: 1/2026.
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 29, 2025

Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01.

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended 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-0241-2025
Lot/product code:
Lot Numbers: 19232540, 19232524, 19232553, Exp.: 5/2025; 19240510, Exp.: 1/2026; 19241489, Exp.: 3/2026; 19243905, 19243935, Exp.: 9/2026.
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 29, 2025

Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended 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-0233-2025
Lot/product code:
Lot Numbers: 19233792, Exp.: 8/2025; 19233795, Exp.: 8/2025; 19234258, Exp.: 9/2025; 19240912, Exp.: 2/2026; 19241476, 19241477, Exp.: 3/2026; 19242599, Exp.: 6/2026; 19243163, 19243162, Exp.:7/2026;19243884, 19243887, Exp.:9/2026.
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 29, 2025

Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01.

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

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

Recall #:
D-0239-2025
Lot/product code:
Lot Numbers: 19233228, 19233227, Exp.: 7/2025; 19233757, Exp.: 8/2025; 19234229, Exp.: 9/2025; 19235090, Exp.: 11/2025; 19241471, Exp.:3/2026; 19242180, Exp.: 5/2026.
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 29, 2025

Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

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

Recall #:
D-0243-2025
Lot/product code:
Lot Numbers: 19233234, 19233253, Exp.: 7/2025; 19234154, Exp.: 9/2025; 19243185, Exp.: 7/2026; 19243951, 19243974, Exp.: 9/2026.
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 29, 2025

Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01.

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended 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-0244-2025
Lot/product code:
Lot Numbers: 19233270, 19233278, 19233285, Exp.: 7/2025; 19233806, Exp.: 8/2025; 19240954, Exp.: 2/2026; 19241854, Exp.: 4/2026.
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)