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Recalls affecting District of Columbia

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

16,214 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 August 26, 2022

TEST CYP (Grapeseed) 200 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

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-1522-2022
Lot/product code:
Lots: 06132022@5 BUD: 09/11/2022; 08082022@17 BUD: 11/06/2022
Recalling firm:
Carolina Infusion
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 26, 2022

TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

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-1526-2022
Lot/product code:
Lots: 06282022@1, BUD: 08/27/2022; 06292022@8, BUD: 08/28/2022; 07012022@19, BUD: 08/30/2022; 07012022@3, BUD: 08/30/2022; 07122022@8, BUD: 09/10/2022; 07132022@9, BUD: 09/11/2022; 07192022@1, BUD: 09/17/2022; 07292022@9, BUD: 09/27/2022; 08032022@10, BUD: 10/02/2022; 08092022@2, BUD: 10/08/2022; 08102022@1, 08102022@6, 08102022@7, BUD: 10/09/2022; 08152022@5, BUD: 10/14/2022; 08192022@1, 08192022@10, BUD: 10/18/2022
Recalling firm:
Carolina Infusion
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled August 26, 2022

QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

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-1534-2022
Lot/product code:
Lot: 08082022@3, BUD: 10/07/2022
Recalling firm:
Carolina Infusion
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 21, 2022

Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30

Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).

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-1547-2022
Lot/product code:
Lot#: 3192818, Exp 10/31/2022; 3199700, Exp 03/31/2023; 3203853, Exp 02/29/2024
Recalling firm:
Akorn, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 21, 2022

Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748-018-60), c) 100-count bottle (NDC 61748-018-01), Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031.

Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).

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-1548-2022
Lot/product code:
Lot#: a) 3192827, Exp 10/31/2022; 3196136, Exp 12/31/2022; 3202198, Exp 07/31/2023; 3203658, Exp 07/31/2023; 3209114, Exp 11/30/2023; 3203851, Exp 02/29/2024; b) 3191254, Exp 09/30/2022; 3192820, Exp 09/30/2022; 3192822, Exp 10/31/2022; 3192824, Exp 10/31/2022; 3192825, Exp 10/31/2022; 3196141, Exp 01/31/2023; 3196143, Exp 02/28/2023; 3203870, Exp 11/30/2023; 3203871, Exp 02/29/2024; c) 3190636, Exp 09/30/2022; 3192813, Exp 09/30/2022; 3196132, Exp 12/31/2022; 3196133, Exp 12/31/2022; 3196138, Exp 01/31/2023; 3199702, Exp 03/31/2023; 3199703, Exp 03/31/2023
Recalling firm:
Akorn, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 26, 2022

Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520; Made in India, NDC 55150-154-10.

Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside 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-0013-2023
Lot/product code:
Lot: AC22006, Exp 08/2023
Recalling firm:
AuroMedics Pharma LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 30, 2022

Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408; NDC 50742-317-25 UPC 3 50742 31725 7

Not meeting quality requirements for related substances (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-0010-2023
Lot/product code:
Lot #: 22E040 Exp. 07/2023; 22F038 Exp. 08/2023
Recalling firm:
Ingenus Pharmaceuticals Llc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 5, 2022

Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-162-90

CGMP Deviations: Detection of N-Nitroso-quinapril impurity 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-0021-2023
Lot/product code:
Lots QE2021005-A and QE2021010-A, exp 01/2023
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled October 7, 2022

TASTYKAKE GLAZED APPLE PIE NET WT 4.5 OZ (128g) UPC 0 25600 00972 7 DISTRIBUTED BY TASTY BAKING COMPANY, PHILADELPHIA, PA 19112

During an internal inspection the firm discovered that several products may contain soy lecithin which is not declared on the labels.

Full report

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

Recall #:
F-0067-2023
Lot/product code:
Enjoy By Dates of Oct. 28, Oct. 31, Nov. 4, and Nov. 7; Product Codes 307 2263 through 307 2274
Recalling firm:
Flowers Foods (Corporate Offices)
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled October 7, 2022

TASTYKAKE GLAZED LEMON FLAVORED PIE NET WT 4.5 OZ (128g) UPC 0 25600 00967 3 DISTRIBUTED BY TASTY BAKING COMPANY, PHILADELPHIA, PA 19112

During an internal inspection the firm discovered that several products may contain soy lecithin which is not declared on the labels.

Full report

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

Recall #:
F-0070-2023
Lot/product code:
Enjoy By Dates of Oct. 28, Oct. 31, Nov. 4, and Nov. 7; Product Codes 307 2263 through 307 2274
Recalling firm:
Flowers Foods (Corporate Offices)
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled October 7, 2022

TASTYKAKE GLAZED CHERRY PIE NET WT 4.5 OZ (128g) UPC 0 25600 00969 7 DISTRIBUTED BY TASTY BAKING COMPANY, PHILADELPHIA, PA 19112

During an internal inspection the firm discovered that several products may contain soy lecithin which is not declared on the labels.

Full report

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

Recall #:
F-0069-2023
Lot/product code:
Enjoy By Dates of Oct. 28, Oct. 31, Nov. 4, and Nov. 7; Product Codes 307 2263 through 307 2274
Recalling firm:
Flowers Foods (Corporate Offices)
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled October 7, 2022

Mrs. Freshley's Apple Fruit Pie NET WT 4.5 OZ (128g) UPC 0 72250 00817 4 DISTRIBUTED BY FLOWERS FOODS SPECIALTY GROUP, LLC, 5987 SOUTH ROYAL ATLANTA DR, TUCKER, GA 30084

During an internal inspection the firm discovered that several products may contain soy lecithin which is not declared on the labels.

Full report

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

Recall #:
F-0065-2023
Lot/product code:
Enjoy By Dates of Oct. 28, Oct. 31, Nov. 4, and Nov. 7; Product Codes 307 2263 through 307 2274
Recalling firm:
Flowers Foods (Corporate Offices)
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled October 7, 2022

Mrs. Freshley's Cherry Fruit Pie NET WT 4.5 OZ (128g) UPC 0 72250 0081 0 DISTRIBUTED BY FLOWERS FOODS SPECIALTY GROUP, LLC, 5987 SOUTH ROYAL ATLANTA DR, TUCKER, GA 30084

During an internal inspection the firm discovered that several products may contain soy lecithin which is not declared on the labels.

Full report

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

Recall #:
F-0066-2023
Lot/product code:
Enjoy By Dates of Oct. 28, Oct. 31, Nov. 4, and Nov. 7; Product Codes 307 2263 through 307 2274
Recalling firm:
Flowers Foods (Corporate Offices)
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled October 7, 2022

TASTYKAKE GLAZED CARAMEL APPLE PIE NET WT 4.5 OZ (128g) UPC 0 25600 08618 6 DISTRIBUTED BY TASTY BAKING COMPANY, PHILADELPHIA, PA 19112

During an internal inspection the firm discovered that several products may contain soy lecithin which is not declared on the labels.

Full report

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

Recall #:
F-0068-2023
Lot/product code:
Enjoy By Dates of Oct. 28, Oct. 31, Nov. 4, and Nov. 7; Product Codes 307 2263 through 307 2274
Recalling firm:
Flowers Foods (Corporate Offices)
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 11, 2022

0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10

Not guaranteed to be germ-free: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.

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-0015-2023
Lot/product code:
Lot # 22EU05043, EXP 5/21/2023; 22HU05018, EXP 6/9/2023; 22HU05019, EXP 6/10/2023; 22HU05025, 22HU05026, EXP 6/12/2023; 22HU05049, EXP 6/22/2023; 22HU05053, EXP 6/24/2023; 22HU05054, 22HU05055, EXP 6/25/2023; 22HU06027, EXP 6/11/2023; 22HU06049, EXP 6/23/2023; 22HU06055, EXP 6/24/2023; 22HU06056, EXP 6/25/2023; 22JU05008, EXP 7/4/2023; 22KU06036, EXP 8/19/2023; 22JU06023, EXP 7/8/2023
Recalling firm:
Fresenius Medical Care Holdings, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 13, 2022

GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in Goinoscopic Examinations, Mfd. by: Akorn, INc., Lake Forest, IL 60045. NDC: 17478-064-12

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-0140-2023
Lot/product code:
Lot: 0C80A, EXP 2/28/2023; 0B71A, 1B32A, EXP 1/31/2023; 0C80B, EXP 2/28/2023; 0F68A, EXP 5/31/2023; 0G85A, 0G01A, 1G54A, 1G71A, EXP 6/30/2023; 0H32A, 0H47A, 1H75A, EXP 7/31/2023; 0K22A, EXP 9/30/2023; 0M90A, EXP 11/30/2023;
Recalling firm:
Akorn, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 13, 2022

Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 60045. NDC: 17478-519-19

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-0144-2023
Lot/product code:
Lot, Expiry: Lots 1E28A, exp 4/30/2023
Recalling firm:
Akorn, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 13, 2022

Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-714-25

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-0136-2023
Lot/product code:
Lot: Lot 1E22A, EXP 10/31/2022
Recalling firm:
Akorn, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 13, 2022

AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-238-35

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-0132-2023
Lot/product code:
Lot # 0G87A, EXP 06/30/2023
Recalling firm:
Akorn, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 13, 2022

Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 60429-957-05

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-0151-2023
Lot/product code:
Lot: 1C61A, EXP 2/28/2023; 1D86A, 1D07A, EXP 3/31/2023;
Recalling firm:
Akorn, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 13, 2022

PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-704-12

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-0152-2023
Lot/product code:
Lot: 0B55A, EXP 1/31/2023; 0D16A, 0D23A, EXP 3/31/2023; 0E51A, EXP 4/30/2023; 1C46A, EXP 2/29/2024;
Recalling firm:
Akorn, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 13, 2022

Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-105-05

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-0147-2023
Lot/product code:
Lot: Lot 1B41A, EXP 1/31/2023
Recalling firm:
Akorn, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 13, 2022

Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b) 30 mL tube NDC 17478-711-30; Rx only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045.

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-0143-2023
Lot/product code:
Lot: (a) 0A02B, 0A02D, 0A02C, 0A02A, 0A02E, EXP 12/31/2022; 0B60C, 0B46B, 0B60D EXP 1/31/2023; 0B67B, 0B67D, 0B60B, 0B60A, 0B67A, 0B46D, 0B67C, 0B46A, EXP 1/31/2023; 0C78B, 0C78D, 0C78C, EXP 2/28/2023; 0D11A, 0D11C, 0D11B, 0D11D, EXP 3/31/2023 0E35C, 0E35B, 0E35A, EXP 4/30/2023; 0J63B, 0J63C, EXP 8/31/2023; 0K02A, 0K02C, 0K02D, 0K02B, EXP 9/30/2023; 0L47B, 0L47C, 0L47A, EXP 10/31/2023; 1B12B, 1B12A, 1B23A, 1B23F, 1B12C, 1B23B, 1B23D, 1B23E, 1B12D, EXP 1/31/2024; 1C66C, 1C66A, EXP 2/29/2024; 1D93B, 1D93D, 1D93C, 1D99B, 1D99C, 1D99A, 1D93A, 1D99D, EXP 3/31/2024 1H96C, 1H96D, 1H96E, EXP 7/31/2024; 1J37B, 1J47B, 1J47D, 1J37C, 1J37A, 1J47C, EXP 8/31/2024; 1L18D, 1L98C, 1L18C, 1L18A, 1L98B, 1L98D, 1L18B, 1L98E, EXP 10/31/2024; 2D21B, EXP 3/31/2025 (b) 0A06A, 0A37A , EXP 12/31/2022; 0B44A, EXP 1/31/2023; 0C88A, 0C84A, EXP 2/28/2023; 0D21A, 0D08A, EXP 3/31/2023; 0E46A, 0E46B, 0E31A, 0E48A, EXP 4/30/2023; 0F72A, 0F58A, EXP 5/31/2023; 0G05A, EXP 6/30/2023; 0H41A, EXP 7/31/2023; 0J67A, 0J67B, EXP 8/31/2023; 0K15B, 0K15A, EXP 9/30/2023; 0L56B, EXP 10/31/2023; 1B20A, EXP 1/31/2024; 1C47A, 1C52A, EXP 2/29/2024; 1D84B,1D84A, EXP 3/31/2024; 1G61A, 1G64A, 1G72A, EXP 6/30/2024; 1J51A, 1J28A, EXP 8/31/2024; 1K63A, 1K69A, 1K73A, 1K69B, 1K69C, EXP 9/30/2024; 1L15B, EXP 10/31/2024; 2C08A,EXP 2/28/2025;
Recalling firm:
Akorn, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 13, 2022

Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-290-10

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-0157-2023
Lot/product code:
Lot: 1C56A, EXP 2/28/2023; 1J50A, EXP 8/31/2023; 1K61A, EXP 9/30/2023 ; 1M27A, EXP 11/30/2023;
Recalling firm:
Akorn, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 13, 2022

Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-622-35

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-0155-2023
Lot/product code:
Lot: 0F69A, EXP 5/31/2023; 0G92B, 0G92A, EXP 6/30/2023; 0J69A, EXP 8/31/2023; 0K29A, 0K24A, EXP 9/30/2023; 0M93A, 0M92A, 0M92B, EXP 11/30/2023; 1B25A, EXP 1/31/2024; 1C74A, EXP 2/29/2024; 1E19A, EXP 4/30/2024; 1C77A, EXP 2/29/2024;
Recalling firm:
Akorn, Inc.
View official FDA record (opens in a new tab)