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Recalls affecting Hawaii

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

16,268 recalls found
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Just announced

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

Business Pill, Branch Manager for Men — dietary supplements marketed for male sexual enhancement

Products contain undeclared yohimbine

▸Full report
Dietary SupplementsFood & Beverages

Recalling firm: SUPPLX.com

Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.

Company contact: (321) 341-9501 · SupplxRecall@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced September 4, 2026

Foods Alive — Moringa Leaf Powder

Potential to be contaminated with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Foods Alive Inc.

Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

B. Braun — 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container

Presence of particulate matter identified as iron oxide

▸Full report
Drugs

Recalling firm: B. Braun Medical Inc.

“On September 3, 2026 firm updated their press release to include additional contaminants.” FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified as iron…

Company contact: recalls@bbraunusa.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusE. coliAnnounced September 3, 2026

Great Value — Organic Triple Berry Blend

Possible E. Coli Contamination

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Frutas y Hortalizas del Sur S.A.

September 02, 2026. Frutas y Hortalizas del Sur S.A., San Carlos, Chile expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145:H28 (E. coli O145) .

Company contact: Info.foodsafety@comfrut.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced September 3, 2026

American Regent, Inc. — Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial

Presence of particulate matter and lack of sterility assurance

▸Full report
Food & Beverages

Recalling firm: American Regent, Inc.

FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in lack of assurance of sterility.

View FDA’s announcement (opens in a new tab)
UnclassifiedUndeclaredAnnounced August 31, 2026

Lipofit — Lipofit Extreme 2.0 Fat Burner Dietary Supplement

Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)

▸Full report
Dietary SupplementsDrugs

Recalling firm: Ana Salazar Modela Tu Cuerpo Inc.

FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level.

Company contact: (954) 305-1004 · yandrydy@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedAnnounced August 31, 2026

Kofinas — Garlic Mediterranean Infused Extra Virgin Olive Oil 500 ml, 250 ml, and 100 ml

Contains garlic essential oil not approved for culinary use

▸Full report
Food & BeveragesIngredients

Recalling firm: LMSI LLC

Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.

View FDA’s announcement (opens in a new tab)
UnclassifiedAllergenMilkUndeclaredAnnounced August 31, 2026

Little Temptations — Chocolatey Eyeballs, 7 oz., 10 oz., 10.5 oz., 11 oz., and 16 oz.

Undeclared milk

▸Full report
Food & BeveragesAllergens

Recalling firm: Crystal Temptations

Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaE. coliAnnounced August 29, 2026

Everything Sprouts — Robust Radish Mix, 5oz Cups

Potential to be contaminated with Shiga toxin-producing Escherichia coli (STEC) or Salmonella.

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Everything Sprouts, LLC

Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.

Company contact: everythingsproutsmn@gmail.com

View FDA’s announcement (opens in a new tab)
UnclassifiedBacteria/virusSalmonellaAnnounced August 29, 2026

Martina — Mangoes

Potential contamination with Salmonella

▸Full report
Food & BeveragesFoodborne Illness

Recalling firm: Panorama Produce

MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Company contact: information@panoramaproduce.com

View FDA’s announcement (opens in a new tab)
Wording
Class IIModerate risk
DrugRecalled March 11, 2025

chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim 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-0309-2025
Lot/product code:
Lot#s: 17232222 and 17232237, Exp 10/31/2025
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 11, 2025

Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05

Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

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-0282-2025
Lot/product code:
Lot: 084A067, Exp 12/31/2025
Recalling firm:
FDC Limited
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugChemicalRecalled March 11, 2025

Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz (18.4g) tube in a carton; Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015

Chemical contamination: presence of benzene

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-0283-2025
Lot/product code:
Lot #: 4970743B, 4970743C Exp 3/31/2026, 9722793A, Exp 9/30/2026; 8363513A, Exp 12/3/2026; 2822284A, Exp 8/31/2027; 2143554A, Exp 12/31/2027.
Recalling firm:
Fruit Of The Earth, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugChemicalRecalled March 11, 2025

CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc

Chemical contamination: presence of benzene

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-0284-2025
Lot/product code:
Lot #: 4970743A, Exp 3/31/2026; 9712793A, Exp9/30/2026; 8363513B, Exp 12/31/2026; 1391304A, 5101574A, Exp 5/31/2027; 1292084A, 1292084B, 1292084C, Exp 7/31/2027; 2892384A, Exp 8/31/2027; 6203044A, 6203044B, Exp 10/31/2027; 2153564A, 2153564B, Exp 12/31/2027; 2163564A, Exp 1/31/2028
Recalling firm:
Fruit Of The Earth, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 7, 2025

Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

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-0278-2025
Lot/product code:
Lot # 07711, Exp 07/2025; 08900, Exp 09/2026; 08899, Exp 09/2026
Recalling firm:
Slate Run Pharmaceuticals
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 7, 2025

8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial: 51754-5001-1; NDC Carton: 51754-5001-4

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-0303-2025
Lot/product code:
Lots: 10006417 and 10006418, Exp. 11/30/2026
Recalling firm:
Exela Pharma Sciences LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 7, 2025

Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only, Manufactured for: Asegua Therapeutics LLC an affiliate of Gilead Sciences, Inc., Foster City, CA 94404, Made in Ireland, NDC# 72626-2701-1

Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.

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-0313-2025
Lot/product code:
Lot# 24ASV002UA, Exp Date: 6/30/2028
Recalling firm:
ASEGUA THERAPEUTICS LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 7, 2025

Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim 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-0568-2025
Lot/product code:
Lot #: a) 15AU2420, 01JY2407, 04OC2411, Exp 01/31/2027; 12SE2418, 24OC2424, 20NO2416, Exp 03/31/2027; 21AU2313, 21JY2311, 05JY2313, Exp Date 01/31/2026 b) 13OC2310, 05SE2304, 04AU2306, 21JY2317, 12JY2306, Exp 01/31/2026; 11JY2416, 28JU2414, 19AU2412, 02AU2409, Exp 01/31/2027; 11SE2416, 24OC2425, Exp 03/31/2027; c) 23AU2317, 21AU2314, Exp 01/31/2026.
Recalling firm:
Direct Rx
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 7, 2025

Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-443-20.

Stronger than it should be Drug: not meeting quality requirements potency results were obtained.

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-0291-2025
Lot/product code:
Lot 3115773, Exp. 03/31/2025
Recalling firm:
Mylan Institutional, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 7, 2025

Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim 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-0567-2025
Lot/product code:
Lot #: 02AU2406, Exp 01/31/2027
Recalling firm:
Direct Rx
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 7, 2025

Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

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-0279-2025
Lot/product code:
Lot # 109797, Exp 11/2026
Recalling firm:
Slate Run Pharmaceuticals
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 7, 2025

Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-445-20.

Stronger than it should be Drug: not meeting quality requirements potency results were obtained.

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-0290-2025
Lot/product code:
Lot 3116074, Exp. 09/30/2025
Recalling firm:
Mylan Institutional, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 6, 2025

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75

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-0296-2025
Lot/product code:
Lot, expiry: Lots 10140284, 10140285, 10140315, 10140316, exp 04/08/2025; Lot 10140510, exp 04/14/2025; Lot 10140916, exp 04/24/2025
Recalling firm:
QuVa Pharma, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 6, 2025

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1259-75

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-0297-2025
Lot/product code:
Lot, expiry: Lot 10140303, exp 04/14/2025; Lots 10140867, 10140868, exp 04/24/2025; Lot 10140965, exp 04/28/2025
Recalling firm:
QuVa Pharma, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 6, 2025

fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75

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-0295-2025
Lot/product code:
Lots: 10140259, 10140539, 10140687, 10140688; Exp 04/24/2025
Recalling firm:
QuVa Pharma, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 5, 2025

La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System, 3 Step Acne Routine Kit, Medicated Gel Cleanser 3.4 fl. oz. (100 mL) Tube, Clarifying Solution 3.4 fl. oz. (100 mL) Tube, Dual Action Acne Treatment 0.7 fl. oz. (20 mL: UPC 883140035275) Tube, (benzoyl peroxide 0.5% and benzoyl peroxide 5.5% and salicylic acid 2%), La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, France, UPC 883140035282 (kit).

CGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.

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-0418-2025
Lot/product code:
Lot #s, Expiration Dates: MYX30W, Exp 03/31/2025 MYX32W, Exp 03/31/2025 MYX33W, Exp 03/31/2025 MYX41W, Exp 04/30/2025 MYX42W, Exp 04/30/2025 MYX43W, Exp 04/30/2025 MYX44W, Exp 04/30/2025 MYX45W, Exp 04/30/2025 MYX50W, Exp 05/31/2025 MYX51W, Exp 04/30/2025 MYX52W, Exp 04/30/2025 MYX53W, Exp 05/31/2025 MYX70W, Exp 07/31/2025 MYX80W, Exp 07/31/2025 MYX81W, Exp 07/31/2025 MYX90W, Exp 08/31/2025 MYX91W, Exp 08/31/2025 MYX92W, Exp 08/31/2025 MYX93W, Exp 08/31/2025 MYXD0W, Exp 09/30/2025 MYXO1W, Exp 09/30/2025 MYXO2W, Exp 09/30/2025 MYXO3W, Exp 09/30/2025 MYXO4W, Exp 09/30/2025 MYXO5W, Exp 09/30/2025 MYY21W, Exp 02/28/2026 MYY23W, Exp 02/28/2026 MYY26W, Exp 02/28/2026 MYY27W, Exp 02/28/2026 MYY31W, Exp 03/31/2026 MYY32W, Exp 11/30/2025 MYY33W, Exp 11/30/2025 MYY34W, Exp 03/31/2026 MYY50W, Exp 05/31/2026 MYY51W, Exp 05/31/2026 MYY60W, Exp 05/31/2026 MYY61W, Exp 03/31/2026 MYY62W, Exp 06/30/2026 MYY63W, Exp 06/30/2026 MYY64W, Exp 06/30/2026 MYY72W, Exp 06/30/2026 MYY73W, Exp 06/30/2026 MYY74W, Exp 06/30/2026 MYY75W, Exp 06/30/2026 MYY76W, Exp 06/30/2026.
Recalling firm:
L'Oreal USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 5, 2025

Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02

Presence of foreign substance: Presence of Benzene.

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-0293-2025
Lot/product code:
Lot #: 5501127A, 5501236A, Exp Apr-25; 5501341A, Exp Jun-25; 5501406A, Exp Jul-25; 5501408A, Exp Aug-25; 5501516A, Exp Sep-25; 5501568A, Exp Oct-25; 5501829A, Exp Mar-26; 5502000A, Exp Jul-26; 5502004A, 5502005A, Exp Aug-26; 5502092A, Exp Oct-26; 5502217A, Exp Dec-26; 5502262A, Exp Jan-27
Recalling firm:
Strides Pharma, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 5, 2025

PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30

Failed Dissolution Specifications

ALL 50 STATES
▸Full report

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

Recall #:
D-0287-2025
Lot/product code:
Lot no's: GS059908, GS060228, GS060709, GS061233, GS061704, GS062158, GS062405, Exp.: 04/30/2026
Recalling firm:
Golden State Medical Supply Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 5, 2025

Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim 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-0277-2025
Lot/product code:
Lot #: DTB23111A, Exp 8/31/2025
Recalling firm:
Rising Pharma Holding, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 5, 2025

Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-152-02

Presence of foreign substance: Presence of Benzene.

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-0294-2025
Lot/product code:
Lot #: 5501103A, Exp Mar-25; 5501237A, 5501238A, Exp Apr-25; 5501278A, Exp May-25; 5501280A, 5501342A, Exp Jun-25; 5501372A, Exp Jul-25; 5501496A, Exp Aug-25; 5501499A, Exp Sep-25; 5501580A, Exp Oct-25; 5501582A, Exp Dec-25; 5501653A, 5501656A, Exp Jan-26; 5501770A, Exp Feb-26; 5501842A, 5501868A, 5501882A, Exp Apr-26; 5501957A, Exp May-26; 5502001A, Exp Jul-26; 5502033A, Exp Aug-26; 5502112A, 5502115A, Exp Oct-26; 5502180A, 5502181A, Exp Nov-26.
Recalling firm:
Strides Pharma, Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugChemicalRecalled March 5, 2025

La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, 40 mL (135 FL. OZ.) Tube per carton, La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, Laboratoire Dermatologique, CAI 86270, La Roche-Posay, France, UPC 883140500759.

Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.

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-0417-2025
Lot/product code:
Lot #: MYX46W, Exp 04/30/2025
Recalling firm:
L'Oreal USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 5, 2025

La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, a) UPC 3606000508804, 20 mL (0.7 fl. oz.) Tube per Carton, b) 883140500759, 40 mL (1.35 fl. oz.) Tube per Carton, La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, France.

CGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.

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-0419-2025
Lot/product code:
a) Lot #s, Expiration dates: MYX30W 03/2025 MYX43W 04/2025 MYX41W 04/2025 MYX42W 04/2025 MYX40W 04/2025 MYX51W 05/2025 MYX50W 05/2025 MYX60W 05/2025 MYX71W 06/2025 MYX90W 08/2025 MYX91W 09/2025 MYX92W 08/2025 MYXO0W 09/2025 MYX93W 09/2025 MYXD1W 11/2025 MYXD2W 11/2025 MYXDOW 09/2025 MYXD4W 11/2025 MYXD3W 11/2025 MYY22W 02/2026 MYY21W 02/2026 MYY20W 02/2026 MYY41W 04/2026 MYY40W 04/2026 MYY42W 04/2026 MYY43W 04/2026 MYY52W 05/2026 MYY51W 05/2026 MYY50W 05/2026 MYY60W 06/2026 b) Lot #s, Expiration dates MYX31W 3/2025 MYX32W 3/2025 MYX33W 3/2025 MYX34W 3/2025 MYX35W 3/2025 MYX40W 3/2025 MYX41W 4/2025 MYX42W 4/2025 MYX44W 4/2025 MYX45W 4/2025 MYX47W 4/2025 MYX48W 4/2025 MYX49W 4/2025 MYX50W 5/2025 MYX51W 5/2025 MYX52W 5/2025 MYX70W 6/2025 MYX71W 6/2025 MYX72W 7/2025 MYX73W 7/2025 MYX74W 7/2025 MYX75W 7/2025 MYX77W 7/2025 MYX78W 7/2025 MYX80W 8/2025 MYX81W 7/2025 MYX82W 8/2025 MYX83W 8/2025 MYX84W 7/2025 MYXO0W 9/2025 MYXO1W 8/2025 MYXO3W 8/2025 MYXO4W 9/2025 MYXO5W 9/2025 MYXO7W 9/2025 MYXO8W 8/2025 MYXO9W 9/2025 MYXD0W 11/2025 MYXD1W 12/2025 MYXD2W 11/2025 MYXD3W 11/2025 MYXD4W 11/2025 MYXD5W 11/2025 MYXD6W 12/2025 MYY22W 02/2026 MYY23W 02/2026 MYY30W 02/2026 MYY31W 03/2026 MYY32W 03/2026 MYY40W 03/2026 MYY41W 04/2026 MYY42W 04/2026 MYY43W 04/2026 MYY51W 04/2026 MYY60W 06/2026 MYY61W 06/2026 MYY62W 06/2026 MYY63W 06/2026 MYY64W 06/2026 MYY65W 06/2026 MYY66W 06/2026
Recalling firm:
L'Oreal USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled March 4, 2025

Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured by Adare Pharmaceuticals, Inc., Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409, UPC # 0 41167 0014 0

CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.

ALL 50 STATES
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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-0266-2025
Lot/product code:
Lot# 252807, Exp: 5/31/2025; 252808, Exp: 6/30/2025; 372560, Exp: 11/30/2025; 489576, 493447, Exp: 4/30/2026.
Recalling firm:
Chattem Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugChemicalRecalled February 28, 2025

Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 200 Wilmont RD, Deerfield, IL, Made in Canada. UPC#: 1 9560203602 8

Chemical Contamination: Presence of benzene

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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-0274-2025
Lot/product code:
Lot#: 23-09328, Exp.: 09/2025
Recalling firm:
Sigan Industries Group Inc.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled February 28, 2025

Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim 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-0271-2025
Lot/product code:
Lot#: 240098C, Expiration: 01/2027.
Recalling firm:
Breckenridge Pharmaceutical, Inc.
View official FDA record (opens in a new tab)