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Recalls affecting Missouri

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

16,966 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 May 2, 2023

VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-254-25

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-0640-2023
Lot/product code:
Lot #: AC-016641, Exp. Date 06/03/2023; AC-016653 Exp. Date 07/26/2023
Recalling firm:
Apollo Care, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 2, 2023

VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-184-25

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-0647-2023
Lot/product code:
Lot #: AC-016633, Exp. Date 05/24/2023; AC-016651, Exp. Date 07/22/2023
Recalling firm:
Apollo Care, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 2, 2023

VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-284-25

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-0638-2023
Lot/product code:
Lot #: AC-016647, Exp. Date 06/28/2023
Recalling firm:
Apollo Care, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 2, 2023

VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-264-25

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-0639-2023
Lot/product code:
Lot #: AC-016647, Exp. Date 06/28/2023
Recalling firm:
Apollo Care, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 2, 2023

VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-194-50

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-0641-2023
Lot/product code:
Lot #: AC-016648, Exp. Date 07/01/2023
Recalling firm:
Apollo Care, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 2, 2023

VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-224-50

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-0643-2023
Lot/product code:
Lot #: AC-016649, Exp. Date 07/01/2023
Recalling firm:
Apollo Care, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 2, 2023

Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-500-25

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-0644-2023
Lot/product code:
Lot #: AC-016640, Exp. Date 06/16/2023; AC-016670, Exp. Date 08/29/2023
Recalling firm:
Apollo Care, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 2, 2023

PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe, Solution for IV Use Only. Apollo Care, LLC, 3801 Mojae Ct., Suite 101, Columbia, MO 65202. NDC: 71170-010-10

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-0632-2023
Lot/product code:
Lot #: AC-016606, Exp. Date 05/06/2023; AC-016636, Exp. Date 07/09/2023; AC-016643, Exp. Date 07/31/2023
Recalling firm:
Apollo Care, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 3, 2023

Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Incorporated, 333 Strawberry Field Road, Warwick, RI 05886. NDC 70309-080-02

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

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-0774-2023
Lot/product code:
Lot 8640, Exp: 11/2023
Recalling firm:
Denison Pharmaceuticals, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 3, 2023

Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

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-0773-2023
Lot/product code:
Lot 8290V, Exp: 10-2023
Recalling firm:
Denison Pharmaceuticals, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 3, 2023

Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

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-0772-2023
Lot/product code:
Lot: 8314, Exp: 04/2023, 8753, 8753A, Exp: 10/2023; 8659, Exp: 08-2023
Recalling firm:
Denison Pharmaceuticals, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 3, 2023

Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

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-0775-2023
Lot/product code:
Lot 8639, Exp: 8/2023
Recalling firm:
Denison Pharmaceuticals, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 9, 2023

HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0600-2

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Full report

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

Recall #:
D-0776-2023
Lot/product code:
Lot #: 20230222-45AB24, BUD: 8/21/2023; Lot #: 20230110-058361, BUD: 7/9/2023; Lot #: 20221208-0F5483, BUD: 6/6/2023; Lot #: 20221109-45BA60, BUD: 5/8/2023; Lot #:20220929-523FD5, BUD: 3/28/2023; Lot#: 20220914-5D5AE0, BUD: 3/13/2023; Lot #: 220502-024, BUD: 10/29/2022; Lot #: 220510-035, BUD: 11/6/2022; Lot #: 220526-015, BUD: 11/22/2022; Lot#: 220811-010, BUD: 2/7/2023
Recalling firm:
SSM Health Care St. Louis DBA SSM St. Clare Health Center
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 11, 2023

Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive Rx, 3831 Golf Dr A, Houston, TX 77018, NDC: 99000-9278-64.

Weaker than it should be Drug

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-0771-2023
Lot/product code:
Lot: 1643397 BUD: 10/16/2023
Recalling firm:
Revive Rx LLC dba Revive Rx Pharmacy
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 12, 2023

ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded by: Empower Pharmacy, 5980 W Sam Houston Pkwy N Ste 300 Houston, TX 77041, NDC 72627-2405-1

Mislabeling: preservative free product labeled as preserved.

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-0865-2023
Lot/product code:
Lot: 606775 BUD: 09/25/2023
Recalling firm:
Empower Clinic Services LLC dba Empower Pharmacy
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 19, 2023

Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10

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-0762-2023
Lot/product code:
Lot: NFG101, EXP: 1/31/2024; Lot: NFG102, EXP: 9/30/2024; Lot: NFG201, 5/31/2025
Recalling firm:
Sagent Pharmaceuticals Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 19, 2023

Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10

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-0763-2023
Lot/product code:
Lots: NFL101, NFL102, EXP: 1/31/2024; Lots: NFL103, NFL104, EXP: 5/31/2024; Lot: NFL201, EXP: 03/31/2025; Lot: NFL202, EXP: 5/31/2025;
Recalling firm:
Sagent Pharmaceuticals Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 19, 2023

Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99

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-0764-2023
Lot/product code:
Lot: NFT101, EXP: 5/31/2024; Lots: NFT201, NFT202, EXP: 2/28/2025; Lots: NFT203, NFT204, EXP: 5/31/2025
Recalling firm:
Sagent Pharmaceuticals Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled May 22, 2023

Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015; NDC 0363-9947-35.

Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was not meeting quality requirements for an impurity.

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-0765-2023
Lot/product code:
Lot: P2200101, P2200178, Exp. date 11/2023; P2200230, Exp. date 12/2023
Recalling firm:
Aurobindo Pharma USA Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 13, 2023

Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed by a) Original Formula Eye Drops, DG health, DISTRIBUTED BY OLD EAST MAIN CO, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 00556 5; b) Publix, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, 3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811, UPC 0 41415 01076 5; c) sterile eye drops, Original Formula, sunmark, Distributed by McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 10939 16733 0, NDC 49348-037-29; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03639 0; e) Eye Drops, Original Formula, GoodSense, Distributed By: Geiss, Destin & Dunn, Inc., Peachtree City, GA 30269, UPC 1 80410 00015 6, NDC 50804-141-01; f) sterile eye drops, Circle K, Product manufactured for: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404 Proudly distributed by Circle K Stores Inc., UPC 1 94283 65185 8; g) Sterile Eye Drops, Regular Formula, Lil Drug Store, Product manufactured for: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404; UPC 3 66715 68324 3; h) Tetrahydrozoline Ophthalmic Solution, Rugby, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, UPC 3 05361 21794 5, NDC 0536-1217-94, i) Leader, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, UPC 0 96295 13645 6, NDC 70000-0454-1; j) REDNESS RELIEF EYE DROPS, CAREone, Distributed by: FOODHOLD USA, LLC, LANDOVER, MD 20785; UPC 0 41520 86531 1, NDC 41520-431-05; k) Eye Drops, Original Formula, Good Neighbor Pharmacy, Distributed By AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087, UPC 0 87701 14975 7, NDC 24385-075-05; l) Eye Drops, ORIGINAL FORMULA, Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, UPC 3 11917 20076 7; m) CVS Health, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 36131 3; n) H-E-B, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43747 4; o) redness relief, Original Redness Reliever Eye Drops, meijer, DIST. BY MEIJER DISTRIBUTION INC., GRAND RAPIDS, MI 49544, UPC 0 41250 82916 4, NDC 41250-814-01; p) Eye Drops, ORIGINAL, Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, UPC 0 70038 47011 3

CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.

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-0897-2023
Lot/product code:
Lot #: a) RG21F01, Exp: 6/30/2023; b) RG21F01, Exp: 6/30/2023; c) RG21F01, Exp: 6/30/2023; d) RG21F01, RG21F02, Exp 6/30/2023; e) RG21F02, RG21F03, Exp 6/30/2023; f) RG21F02, Exp 6/30/2023; g) RG21F02, Exp 6/30/2023; h) RG21F02, Exp 6/30/2023; i) RG21F02, Exp 6/30/2023; j) RG21F02, Exp 6/30/2023; k) RG21F02, Exp 6/30/2023; l) RG21F02, Exp 6/30/2023; m) RG21F03, Exp 6/30/2023; n) RG21F03, Exp 6/30/2023; o) RG21F03, Exp 6/30/2023; p) RG21F03, Exp 6/30/2023
Recalling firm:
K.C. Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 13, 2023

Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polyethylene glycol 400 1%), 0.5 FL OZ (15mL) bottle, packaged in a) equate, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716, 2-0.5 FL OZ (15 mL) Bottles, 1 FL OZ (30 mL) TOTAL, UPC 6 81131 36701 1, NDC 49035-280-02; b) DG health, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 02656 0; c) sunmark, Distributed By McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 10939 62144 3, NDC 49348-037-29; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 36100 3; e) HealthMart, Distributed by McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 52569 13715 4; f) exchange select Artificial Tears, Manufactured for your Military Exchanges by: KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC 6 14299 05620 6; g) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, UPC 7 13733 29692 2, NDC 41250-718-01; h) H.E.B, MADE WITH PRIDE AND CARE FOR H.E.B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; i) GeriCare, Distributed by: Gericare Pharmaceuticals Corp., 1650 63rd St., Brooklyn, NY 11204, UPC 3 57896 18405 6, NDC 57896-181-05

CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.

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-0898-2023
Lot/product code:
Lot #: a) LT21FO2, LT21F03, Exp 6/2023; b) LT21FO2, LT21F03, Exp 6/2023; c) LT21FO2, LT21F03, Exp 6/2023; d) LT21FO2, LT21F03, Exp 6/2023; e) LT21F02, Exp 6/2023; f) LT21F02, Exp 6/2023; g) LT21F03, Exp 6/2023; h) LT21F03, Exp 6/2023; i) LT21F03, Exp 6/2023
Recalling firm:
K.C. Pharmaceuticals, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 21, 2023

Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10

Failed dissolution specification: not meeting quality requirements results observed in 24-month long term stability testing.

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-0923-2023
Lot/product code:
Lot: T2100585, T2100586, T2100587, Exp 12/2023
Recalling firm:
Dr Reddy's Laboratories Limited
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled June 22, 2023

Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Division) Karakhadi, Vadodara 391450, India. NDC 62332-487-12

Defective Delivery System

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-0941-2023
Lot/product code:
Lot #: 220151, 220152, 220153, Exp. Date 11/2024
Recalling firm:
ALEMBIC PHARMACEUTICALS, INC.
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Class IIModerate risk
DrugRecalled June 26, 2023

Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-count bottles, (NDC: 68788-7781-6), d) 90-count bottles (NDC: 68788-7781-9), e) 120-count bottles (NDC: 68788-7781-8), Rx only, Mfg: Dr. Reddy's Laboratories Limited.

Failed Stability 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-0894-2023
Lot/product code:
Lot#: a) H1621S, Exp: 12/31/2023; b) H2321C, Exp: 12/31/2023; c) H0421B, Exp: 12/31/2023; d) H1721E, H1921T, H3121M, Exp: 12/31/2023, e) H2021G, Exp: 12/31/2023
Recalling firm:
Preferred Pharmaceuticals, Inc.
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Class IIModerate risk
DrugRecalled July 11, 2023

Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.

Not guaranteed to be germ-free

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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-0935-2023
Lot/product code:
Lot: OXG301, Exp 12/31/2025
Recalling firm:
Sagent Pharmaceuticals
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