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Recalls affecting Arkansas

Data last updated: September 8, 2026 at 1:13 PM UTC

16,600 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 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/virusAnnounced 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/virusAnnounced 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)
UnclassifiedAllergenUndeclaredAnnounced 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/virusAnnounced 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/virusAnnounced 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)
NewestOldest
High riskLow riskAll
Wording
Class IIModerate risk
DrugRecalled December 22, 2022

Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15

Failed impurities/degradation specifications: not meeting quality requirements for unknown impurities.

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-0091-2023
Lot/product code:
Lot#: 43313, 43342, Exp 12/2023
Recalling firm:
AVKARE LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 28, 2022

Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd, E. Windsor, NJ 08520; Made in India. NDC 55150-155-20

Presence of Particulate Matter: Customer complaint of dark particles found inside the vial

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-0095-2023
Lot/product code:
Lot # AC22004, Expiry: 08/2023
Recalling firm:
Eugia US LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 29, 2022

Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake Forest, IL 60045 USA,

Not guaranteed to be germ-free: Bags have the potential to leak.

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-0097-2023
Lot/product code:
Lot: 5935283, Exp. 12/01/2023
Recalling firm:
Pfizer Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 10, 2023

Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139. NDC 4 oz bottle: 46706-222-01; NDC 8 oz: 46706-222-02

CGMP Deviations: initiated due to violations of CGMP manufacturing practices

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-0325-2023
Lot/product code:
Lots 3217A and 3217B, exp 06/23
Recalling firm:
Consolidated Chemical, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 10, 2023

Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139.

CGMP Deviations: initiated due to violations of CGMP manufacturing practices

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-0326-2023
Lot/product code:
Lot, expiry: Lot 3216, exp 04/23 and 3218, exp 10/23
Recalling firm:
Consolidated Chemical, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 17, 2023

Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 500 mL bottles per case, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel - Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.

CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.

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-0163-2023
Lot/product code:
Lot Numbers: 202160, 202162, 202324, 202368, 202369, 202593, 202594, 202835, 202862, 202863, 202865, 202836, 202864, 203061, 203098, 203099, 203100, 203101, 203102, 203236, 203237, 203239, 203337, 203338, 203335, 203336
Recalling firm:
Fisher Scientific Co., LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 17, 2023

Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged in 4 L bottles, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel - Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.

CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.

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-0164-2023
Lot/product code:
Lot Numbers: 202161, 202322, 202323, 202794, 202858, 203188, 203238, 203240, 203722 203723, 203724, 203725, 204852
Recalling firm:
Fisher Scientific Co., LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 30, 2023

Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.

CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.

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-0920-2023
Lot/product code:
Lot #: PCMH009, PCMH010, PCMH011, PCMH012, PCMH013, PCMH014, PCMH015, PCMH016, exp. date Nov-2023; PCMI001, PCMI002, PCMI003, PCMI004, PCMI006, PCMI 07, PCMI 008, Exp. date AUG-2024; PCMJ003, PCMJ007, PCMJ016, Exp. date MAR-2025
Recalling firm:
Global Pharma Healthcare Private Limited
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled January 30, 2023

Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.

CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.

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-0922-2023
Lot/product code:
Lot #: PCMH003, PCMH004, PCMH006, PCMH008, Exp. date NOV-2023
Recalling firm:
Global Pharma Healthcare Private Limited
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 8, 2023

Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500 090, INDIA; NDC 55111-525-01.

Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg 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-0330-2023
Lot/product code:
Lot # C2106445; Exp. 03/2024
Recalling firm:
Dr. Reddy's Laboratories, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 10, 2023

0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10

Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of 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-0347-2023
Lot/product code:
Lots: 0061794230 Exp. 01/31/2024; 0061794232 Exp. 01/31/2024; 0061797779 Exp. 02/29/2024; 0061797780 Exp. 02/29/2024; 0061797781 Exp. 02/29/2024; 0061797783 Exp. 02/29/2024; 0061797784 Exp. 03/31/2024; 0061797785 Exp. 03/31/2024; 0061797786 Exp. 03/31/2024; 0061797787 Exp. 03/31/2024; 0061797788 Exp. 03/31/2024; 0061809680 Exp. 04/30/2024
Recalling firm:
B. Braun Medical Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 10, 2023

0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00

Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of 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-0346-2023
Lot/product code:
Lots: 0061786962 Exp. 11/30/2023; 0061797767 Exp. 04/30/2024; 0061797768 Exp. 05/31/2024; 0061787769 Exp. 05/31/2024; 0061797770 Exp. 05/31/2024; 0061797771 Exp. 05/31/2024; 0061797772 Exp. 05/31/2024; 0061797773 Exp. 05/31/2024; 0061797774 Exp. 05/31/2024; 0061797775 Exp. 05/31/2024; 0061797776 Exp. 05/31/2024; 0061812946 Exp. 05/31/2024; 0061812947 Exp. 05/31/2024; 0061812948 Exp. 05/31/2024; 0061812949 Exp. 05/31/2024; 0061812950 Exp. 05/31/2024; 0061816017 Exp. 06/30/2024; 0061816018 Exp. 06/30/2024; 0061816019 Exp. 06/30/2024; 0061816020 Exp. 06/30/2024; 0061816021 Exp. 06/30/2024; 0061816358 Exp. 06/30/2024; 0061816359 Exp. 06/30/2024; 0061816361 Exp. 07/31/2024; 0061816362 Exp. 07/31/2024; 0061816363 Exp. 07/31/2024; 0061816364 Exp. 07/31/2024; 0061818516 Exp. 07/31/2024; 0061818517 Exp. 07/31/2024; 0061818518 Exp. 07/31/2024; 0061821562 Exp. 08/31/2024; 0061821563 Exp. 08/31/2024; 0061821564 Exp. 08/31/2024; 0061823709 Exp. 08/31/2024; 0061823710 Exp. 08/31/2024; 0061823711 Exp. 08/31/2024; 0061823714 Exp. 08/31/2024; 0061823715 Exp. 08/31/2024; 0061823716 Exp. 08/31/2024; 0061824770 Exp. 08/31/2024; 0061824771 Exp. 08/31/2024; 0061824772 Exp. 08/31/2024; 0061824773 Exp. 08/31/2024; 0061824774 Exp. 08/31/2024; 0061824775 Exp. 08/31/2024; 0061824776 Exp. 08/31/2024; 0061824777 Exp. 08/31/2024; 0061826486 Exp. 08/31/2024; 0061826487 Exp. 08/31/2024; 0061826488 Exp. 08/31/2024
Recalling firm:
B. Braun Medical Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 14, 2023

Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Manufactured by: Pharmedica USA, Phoenix, AZ, UPC 7 31034 91380 5

CGMP Deviations

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-0457-2023
Lot/product code:
Lot #: 1808051, Exp.: 01/01/2027
Recalling firm:
Pharmedica USA, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 23, 2023

NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid Drops, 0.1% Alcohol, 1 FL OZ( 30mL), Mfd. Nutraceutical Corp., Salt Lake City, UT, 84101 USA, UPC 3 71402 30101 0

CGMP Deviations: Raw material recalled by repackager, due to discoloration.

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-0440-2023
Lot/product code:
Lot 222148, Exp: 05/25;
Recalling firm:
Nutraceutical Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 23, 2023

NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, 0.8 fl oz( 24mL), Mfd. Nutraceutical Corp., NaturalCare Park City, UT, 84098 USA, UPC 3 71400 70801 9

CGMP Deviations: Raw material recalled by repackager, due to discoloration.

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-0437-2023
Lot/product code:
Lot: 221263, Exp: 10/24; 222047, 222048 Exp: 02/25; 222099, 222100, Exp: 03/25
Recalling firm:
Nutraceutical Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 23, 2023

NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for Healthway Corp. Comments or Questions NatraBio Shelburne Falls, MA 01370 USA, UPC 3 71400 55711 2

CGMP Deviations: Raw material recalled by repackager, due to discoloration.

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-0438-2023
Lot/product code:
Lot: 222016, Exp: 01/25;
Recalling firm:
Nutraceutical Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 23, 2023

NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% Alcohol, 1 FL OZ( 30mL), Mfd. for Nutraceutical Corp. NaturalCare Park City, UT, 84098 USA

CGMP Deviations: Raw material recalled by repackager, due to discoloration.

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-0439-2023
Lot/product code:
Lot 222076, Exp: 03/27;
Recalling firm:
Nutraceutical Corporation
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 1, 2023

Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60505 05641 5; b) 10 mL dropper bottle NDC 60505-0564-2, UPC 3 60505 05642 2; c) 15 mL dropper bottle, NDC 60505-0564-3, UPC 3 60505 05643 9; Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326

Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.

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-0433-2023
Lot/product code:
Lots: a) TJ9848 Exp. 02/2024, TJ9849 Exp. 02/2024, TK0258 Exp. 04/2024, TK5341 Exp. 04/2024; b) TK0261 Exp. 04/2024; c) TK0262 Exp. 04/2024
Recalling firm:
Apotex Corp.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 10, 2023

Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5553-3

Defective Delivery System: not meeting quality requirements for shear.

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-0471-2023
Lot/product code:
Lot#: 91956, Exp. 6/2023; 92475, Exp. 7/2023
Recalling firm:
Noven Pharmaceuticals Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 10, 2023

Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5554-3.

Defective Delivery System: not meeting quality requirements for shear.

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-0472-2023
Lot/product code:
Lot#: 91957, 92197, Exp. 7/2023; 92476, Exp. 9/2023; 92477, Exp. 10/2023
Recalling firm:
Noven Pharmaceuticals Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 10, 2023

Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5555-3

Defective Delivery System: not meeting quality requirements for shear.

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-0473-2023
Lot/product code:
Lot#: 91474, 91959, Exp. 3/2023; 91958, Exp. 6/2023; 92478, Exp. 7/2023; 92479 & 92198, Exp. 8/2023; 92199, 93040, Exp. 9/2023; 93041, Exp. 10/2023.
Recalling firm:
Noven Pharmaceuticals Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 10, 2023

Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5552-3.

Defective Delivery System: not meeting quality requirements for shear.

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-0470-2023
Lot/product code:
Lot#: 91955, Exp. 7/2023; 93039, Exp. 10/2023
Recalling firm:
Noven Pharmaceuticals Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 14, 2023

Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ, 08854, By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar- 509 301, India NDC 31722-713-10

CGMP Deviations: Discoloration

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-0530-2023
Lot/product code:
Lot #: PAN22542, Exp. Date: 9/2024
Recalling firm:
Hetero USA Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 14, 2023

Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60.

CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily 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-0534-2023
Lot/product code:
Lot #s: 22142448, 22142449, 22142450, Exp 5/2024; 22143845, Exp 7/2024.
Recalling firm:
Ascend Laboratories, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 14, 2023

Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-474-60.

CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake 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-0533-2023
Lot/product code:
Lot #s: 22142462, 22142463, 22142464, Exp 5/2024; 22143000, 22143001, 22143002, Exp 6/2024.
Recalling firm:
Ascend Laboratories, LLC
View official FDA record (opens in a new tab)