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Recalls affecting Colorado

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

16,771 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/virusSalmonellaAnnounced 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/virusE. coliAnnounced 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)
UnclassifiedAllergenMilkUndeclaredAnnounced 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/virusSalmonellaE. coliAnnounced 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/virusSalmonellaAnnounced 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, 2023

Dr. Berne's Organic Castor Oil Eye Drops, Net WT 30 mL/1 fl oz bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com, Certified Organic by Organic Certifiers.

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-0035-2024
Lot/product code:
Lot: 6666, Exp. 11/30/25
Recalling firm:
Dr. Berne's Whole Health Products
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 1, 2023

TRP Natural Eyes, Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-002-11.

Not guaranteed to be germ-free

Full report

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

Recall #:
D-1154-2023
Lot/product code:
Lot: DC001 EXP: 06/24
Recalling firm:
AMMAN PHARMACEUTICAL INDUSTRIES
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 1, 2023

TRP Natural Eyes, Dryness Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-096-19.

Not guaranteed to be germ-free

Full report

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

Recall #:
D-1156-2023
Lot/product code:
Lot: FR001 EXP: 07/24; Lot: FR004 EXP: 04/25; Lot:FR005 EXP: 04/25; Lot:FR006 EXP: 04/25; Lot: FR007 Exp: 04/25
Recalling firm:
AMMAN PHARMACEUTICAL INDUSTRIES
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 1, 2023

TRP Natural Eyes, Pink Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-094-19.

Not guaranteed to be germ-free

Full report

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

Recall #:
D-1162-2023
Lot/product code:
Lot: FP001 EXP:07/24
Recalling firm:
AMMAN PHARMACEUTICAL INDUSTRIES
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 1, 2023

TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-032-15.

Not guaranteed to be germ-free

Full report

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

Recall #:
D-1152-2023
Lot/product code:
Lot: IY001; EXP 07/24
Recalling firm:
AMMAN PHARMACEUTICAL INDUSTRIES
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 1, 2023

TRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-014-13.

Not guaranteed to be germ-free

Full report

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

Recall #:
D-1165-2023
Lot/product code:
Lot:182002 EXP: 11/24; Lot:182003 EXP: 11/24; Lot:182004 EXP: 12/24; Lot:182005 EXP:02/25; Lot:182006 EXP:02/25; Lot:182007EXP:02/25; Lot:182008 EXP:02/25; Lot:182009 EXP:02/25; Lot:182010 EXP:03/25: Lot:182011 EXP:03/25;
Recalling firm:
AMMAN PHARMACEUTICAL INDUSTRIES
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 1, 2023

TRP Natural Eyes, Dryness Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC:17312-178-15.

Not guaranteed to be germ-free

Full report

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

Recall #:
D-1155-2023
Lot/product code:
Lot: IX001 EXP: 07/24; Lot: IX002 EXP: 12/24
Recalling firm:
AMMAN PHARMACEUTICAL INDUSTRIES
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 1, 2023

TRP Natural Eyes, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-095-19.

Not guaranteed to be germ-free

Full report

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

Recall #:
D-1164-2023
Lot/product code:
Lot: IW001 EXP:07/24; Lot: IW002 EXP: 12/24
Recalling firm:
AMMAN PHARMACEUTICAL INDUSTRIES
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 1, 2023

MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, Made in Jordan, NDC: 0904-6488-38.

Not guaranteed to be germ-free

Full report

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

Recall #:
D-1160-2023
Lot/product code:
Lot: 184001 EXP: 11/24; 184002 EXP: 11/24; 184003 EXP: 11/24; Lot: 184004 EXP: 12/24; Lot: 184005 EXP: 12/24; Lot:184006 EXP:12/24;
Recalling firm:
AMMAN PHARMACEUTICAL INDUSTRIES
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 1, 2023

TRP Natural Eyes, Pink Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-013-15.

Not guaranteed to be germ-free

Full report

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

Recall #:
D-1161-2023
Lot/product code:
Lot: IV001 EXP:06/25; Lot:IV002 EXP: 11/24; Lot:IV004 EXP:01/25
Recalling firm:
AMMAN PHARMACEUTICAL INDUSTRIES
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 1, 2023

TRP Natural Eyes, Eye Lid Relief, Sterile Eye ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-165-13.

Not guaranteed to be germ-free

Full report

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

Recall #:
D-1158-2023
Lot/product code:
Lot: 180001 EXP: 01/25
Recalling firm:
AMMAN PHARMACEUTICAL INDUSTRIES
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 1, 2023

TRP Natural Eyes, Aging Eye Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-027-15.

Not guaranteed to be germ-free

Full report

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

Recall #:
D-1151-2023
Lot/product code:
Lot#:DB001 EXP: 06/24
Recalling firm:
AMMAN PHARMACEUTICAL INDUSTRIES
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 1, 2023

TRP Natural Eyes, Allergy Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-097-19.

Not guaranteed to be germ-free

Full report

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

Recall #:
D-1153-2023
Lot/product code:
Lot: FT001; EXP: 07/24
Recalling firm:
AMMAN PHARMACEUTICAL INDUSTRIES
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 1, 2023

TRP Natural Eyes, Eye Lid Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-417-19.

Not guaranteed to be germ-free

Full report

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

Recall #:
D-1157-2023
Lot/product code:
Lot: FV005 EXP:03/25
Recalling firm:
AMMAN PHARMACEUTICAL INDUSTRIES
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 1, 2023

TRP Natural Eyes, Floaters Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-098-15.

Not guaranteed to be germ-free

Full report

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

Recall #:
D-1159-2023
Lot/product code:
Lot: DA001 EXP: 06/24; Lot: DA002 EXP: 11/24
Recalling firm:
AMMAN PHARMACEUTICAL INDUSTRIES
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 1, 2023

TRP Natural Eyes, Twitching Relief, Sterile Eye Ointment, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-099-15.

Not guaranteed to be germ-free

Full report

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

Recall #:
D-1166-2023
Lot/product code:
Lot:DD001 EXP: 07/24;
Recalling firm:
AMMAN PHARMACEUTICAL INDUSTRIES
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 1, 2023

TRP Natural Eyes, Red Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-058-15.

Not guaranteed to be germ-free

Full report

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

Recall #:
D-1163-2023
Lot/product code:
Lot: FQ001 EXP:07/24
Recalling firm:
AMMAN PHARMACEUTICAL INDUSTRIES
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 1, 2023

octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Innovus Pharmaceuticals, Inc., Englewood, CO 80112, Made in Jordan, NDC:57483-610-15.

Not guaranteed to be germ-free

Full report

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

Recall #:
D-1167-2023
Lot/product code:
Lot: YM308 EXP:10/24;
Recalling firm:
AMMAN PHARMACEUTICAL INDUSTRIES
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodForeign materialRecalled September 19, 2023

Kraft Singles American Pasteurized Prepared Cheese product, 24 individually wrapped slices in flexible film per pack, net wt. per pack 16oz, keep refrigerated. Single pack is sold at retail. Case UPC 0 00 2100007180 7; Single Pack UPC 0 2100061526 1: Each case contains 27 packs. Case UPC 0 00 2100061450 9; Single Pack UPC 0 2100061526 1: Each case contains 36 packs. Case UPC 0 00 2100061524 7; Carton UPC 0 2100060491 3; Single Pack UPC 0 2100061526 1; Each case contains 12 cartons, each carton contains 3 packs (72 slices total per carton).

Plastic fragment. Product is recalled due to potential for a thin strip of the primary packaging film to remain adhered to the cheese slice after the wrapper has been removed.

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-0296-2024
Lot/product code:
Best When Used By Dates on 16oz Single Pack with the UPC of 0 2100061526 1 are: 10 JAN 24 S 72 through 27 JAN 24 S 72 Best When Used By Dates on 16oz Single Pack from the 3lb multipack carton with the UPC of 0 2100060491 3 are: 09 JAN 2024 through 13 JAN 2024, and 16 JAN 2024. Manufacturer Code on Case (UPC 0 00 2100061450 9): DD JAN 24 S 72/73 TT:TT. DD would be between 10-27. Manufacturer Code on Case (UPC 0 00 2100007180 7): XB ZZZ 23 021 DD JAN 2024. ZZZ would be between 163-165, 167, 169-173. Manufacturer Code on Case (UPC 0 00 2100061524 7): XB DDD 23 021 DD JAN 2024. DDD would be between 164-168, 171. DD would be between 09-13, and 16.
Recalling firm:
HEINZ
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 28, 2023

Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intra-articular use only, Shake Well, Not for IV/ID, intraocular, epidural, or intrathecal use, Mfd. in India for Auromedics Pharma LLC., E Windsor, NJ, 08520, NDC 55150-385-01.

Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm 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-0041-2024
Lot/product code:
Lot #: 3TC22010, Exp 11/30/2024
Recalling firm:
Eugia US LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled September 28, 2023

Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per carton, Rx Only, Manufactured By Padagis, Yeruham, Israel; Distributed By: Padagis, Allegan, MI 49010. NDC: 45802-396-01

Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.

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-0081-2024
Lot/product code:
Lot#: 164185, Exp. Date 4/2024
Recalling firm:
Padagis US LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 5, 2023

Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.

CGMP Deviations: OTC products were stored outside of labeled temperature requirements.

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-0045-2024
Lot/product code:
Certain drug products sold by Family Dollar retail stores located in AL, AR, AZ, CA, CO, FL, GA, ID, KS, LA, MS, MT, ND, NE, NM, NV, OK, OR, SD, TX, UT, WA, and WY.
Recalling firm:
Dollar Tree Distribution, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 19, 2023

Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-256-01.

Failed Dissolution Specifications-not meeting quality requirements (OOS) test results observed for dissolution at the 6 month long term time point.

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-0097-2024
Lot/product code:
M213318, exp. date 11/2024; M213314, exp. date 11/2024; M213315, exp. date 11/2024; M214436, exp. date 11/2024; M214437, exp. date 11/2024; M214438, exp. date 11/2024; M300653, exp. date 12/2024; M300654, exp. date 12/2024
Recalling firm:
Zydus Pharmaceuticals (USA) Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 19, 2023

Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-255-01

Failed Dissolution Specifications-not meeting quality requirements (OOS) test results observed for dissolution at the 6 month long term time point.

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-0096-2024
Lot/product code:
M212749, exp. date 11/2024; M214477, exp. date 11/2024; M214478, exp. date 11/2024; M214479, exp. date 11/2024; M214480, exp. date 11/2024
Recalling firm:
Zydus Pharmaceuticals (USA) Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled October 19, 2023

Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-257-01.

Failed Dissolution Specifications-not meeting quality requirements (OOS) test results observed for dissolution at the 6 month long term time point.

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-0098-2024
Lot/product code:
M211541, exp. date 10/2024 M211542, exp. date 10/2024 M212746, exp. date 10/2024 M300660, exp. date 12/2024
Recalling firm:
Zydus Pharmaceuticals (USA) Inc
View official FDA record (opens in a new tab)