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Recalls affecting Massachusetts

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

17,003 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 December 12, 2024

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

CGMP Deviations: Presence of N-nitroso-Dabigatran 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-0130-2025
Lot/product code:
Lot #: 24142192, 24142193, 24142194, Exp. Date April 30, 2026; 24142463, Exp. Date May 31, 2026;
Recalling firm:
Ascend Laboratories, LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 11, 2024

chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended 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-0159-2025
Lot/product code:
Lot#: 17230132, Exp 12/2024; 17230449, Exp 01/2025
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 11, 2024

chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended 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-0160-2025
Lot/product code:
Lot#: 17230133, Exp 12/31/2024
Recalling firm:
Glenmark Pharmaceuticals Inc., USA
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 10, 2024

Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack

Crystallization

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-0172-2025
Lot/product code:
Lots T400514, Exp Date 02/2026 & T400808, Exp Date 03/2026
Recalling firm:
VIONA PHARMACEUTICALS INC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 10, 2024

Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack

Crystallization

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-0171-2025
Lot/product code:
Lots T400513, Exp Date 02/2026; T400807, Exp Date 03/2026; T401152, Exp Date 06/2026; T401303, Exp Date 07/2026; T401304, Exp Date 07/2026; T401399, Exp Date 07/2026 & T401696 Exp Date 08/2026.
Recalling firm:
VIONA PHARMACEUTICALS INC
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled December 9, 2024

1. Cookies & Creme Granola Bars 30.6oz (36 bars) 2. Cookies & Creme Granola Bars 5.1oz (6 bars) 3. Cookies & Creme Granola Bars 0.85 oz.

May contain metal pieces

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-0541-2025
Lot/product code:
1. best by: 05/29/2025 up to and including 10/27/2025 UPC: X002H3FXVZ 2.best by: 05/29/2025 up to and including 12/26/2025 and 02/10/2026 UPC: 687456213743 3. best by: 05/29/2025 up to and including 12/26/2025 and also 02/10/2026 UPC: 687456211145
Recalling firm:
Riverside Natural Foods, Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled December 9, 2024

1. Mixed Berry Granola Bars; 34oz (40 bars) 2. Mixed Berry Granola Bars; 5.1oz (6 bars) 3.

May contain metal pieces

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-0539-2025
Lot/product code:
1. UPC: X002FK87OZ; Best by: 10/04/2025; 11/23/2025; 11/24/2025 and UPC: 10687456216475; best by: 10/04/2025; 11/24/2025 2. UPC: 687456213064 best by: 05/22/2025 up to and including 12/30/2025 and 02/11/2026 and UPC: 00687456215808; best by 07/19/2025; 09/08/2025; 09/16/2025; 01/19/2026
Recalling firm:
Riverside Natural Foods, Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled December 9, 2024

1. Chocolate Banana Granola Bars; 5.1oz (6 bars) 2. Chocolate Banana Granola Bars; 0.85oz

May contain metal pieces

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-0538-2025
Lot/product code:
1. UPC: 687456213088; best by: 05/11/2025 up to and including 01/17/2026 2. UPC: 687456211084; best by: 02/17/2025; 02/22/2025; 03/24/2025; 03/25/2025 and all Best By Dates from 05/11/2025 up to and including 01/17/2026
Recalling firm:
Riverside Natural Foods, Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled December 9, 2024

1. Chocolate Drizzled Cookie Crumble Granola Bars 4.2oz (5 bars) 2. Chocolate Drizzled Cookie Crumble Granola Bars 25.5oz (30 bars) 3. Chocolate Drizzled Cookie Crumble Granola Bars 0.85oz 4. Chocolate Drizzled Granola Bars Variety Pack 25.5oz (30 bars)

May contain metal pieces

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-0544-2025
Lot/product code:
1. best by:01/04/2025 up to and including 09/15/2025 UPC: 687456214177 2. best by: 01/05/2025 up to and including 06/02/2025 UPC: X002SSOR5H 3. best by: 01/04/2025 up to and including 09/15/2025 UPC: 687456914176 4. best by:01/05/2025 up to and including 07/12/2025 UPC: X002SSNEF1
Recalling firm:
Riverside Natural Foods, Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled December 9, 2024

1.Chocolate Drizzled Vanilla Granola Bars 25.5oz (30 bars) 2. Chocolate Drizzled Vanilla Granola Bars 4.2oz (5 bars) 3. Chocolate Drizzled Vanilla Granola Bars 0.85oz

May contain metal pieces

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-0546-2025
Lot/product code:
1. best by:02/14/2025; 03/08/2025; 05/10/2025; 06/25/2025 UPC: X002SSLE1R 2. best by: 02/14/2025 up to and including 08/06/2025 and 09/17/2025 UPC: 687456214153 3. best by: 01/05/2025 up to and including 08/06/2025 and 09/17/2025 UPC: 687456914152
Recalling firm:
Riverside Natural Foods, Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled December 9, 2024

Chocolate Chip Granola Mini Bars, 0.42oz

May contain metal pieces

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-0537-2025
Lot/product code:
UPC: 687456211213 Best by 11/02/2025; 11/03/2025
Recalling firm:
Riverside Natural Foods, Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled December 9, 2024

1. Chocolate Drizzled Birthday Cake Granola Bars 25.5oz (30 bars) 2. Chocolate Drizzled Birthday Cake Granola Bars 4.2oz (5 bars) 3. Chocolate Drizzled Birthday Cake Granola Bars 17oz (20 bars) 4. Chocolate Drizzled Birthday Cake Granola Bars 8.5oz (10 bars) 5. Chocolate Drizzled Birthday Cake Granola Bars 4.2oz (5 bars) 6. Chocolate Drizzled Birthday Cake Granola Bars 0.85oz

May contain metal pieces

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-0543-2025
Lot/product code:
1. best by:01/09/2025 up to and including 06/16/2025 UPC: X002SSIRIF 2. best by: 01/09/2025 up to and including 09/21/2025 UPC: 687456214160 3. best by: 03/05/2025 up to and including 07/25/2025 UPC: 687456215594 4. best by: 01/09/2025 up to and including 09/04/2025 UPC: 687456215709 5. best by: 04/25/2025; 08/29/2025; 05/17/2025 UPC: 687456215815 6. best by: 12/12/2024 up to and including 09/21/2025 UPC: 687456914169
Recalling firm:
Riverside Natural Foods, Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled December 9, 2024

1.Holiday Sprinkles Chocolate Drizzled Granola Mini Bars 10.5oz (25 bars) 2.Holiday Sprinkles Chocolate Drizzled Granola Mini Bars 0.42oz

May contain metal pieces

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-0545-2025
Lot/product code:
1. best by:08/15/2025; 08/22/2025 UPC: 687456214696 2. best by: 08/15/2025; 08/22/2025 not UPC N/A (not labeled for individual sale)
Recalling firm:
Riverside Natural Foods, Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled December 9, 2024

1. Made Good Variety Pack 37ct 2.MadeGood Variety Pack 7ct

May contain metal pieces

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-0547-2025
Lot/product code:
1. best by:12/12/2024 up to and including 07/16/2025 UPC:X0043RL9KR 2. best by: 02/17/2025; 02/22/2025; 03/24/2025; 03/25/2025 UPC: B079LY41VY
Recalling firm:
Riverside Natural Foods, Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled December 9, 2024

1. Halloween Chocolate Chip Granola Mini Bars 12.6oz (30 bars) 2. Halloween Chocolate Chip Granola Mini Bars 0.42oz

May contain metal pieces

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-0542-2025
Lot/product code:
1. best by: 11/02/2025; 11/03/2025 UPC: 687456216508 2. best by: 11/02/2025; 11/03/2025 UPC: 687456211213
Recalling firm:
Riverside Natural Foods, Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled December 9, 2024

1. Strawberry Granola Bars 30.6oz (36 bars) 2. Strawberry Granola Bars 5.1oz (6 bars) 3.Strawberry Granola Bars 0.85oz

May contain metal pieces

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-0540-2025
Lot/product code:
1. best by: 09/06/2025; 10/03/2025; 11/22/2025 UPC: X00485O4XN 2. best by: 09/06/2025; 10/03/2025; 11/22/2025; 01/18/2026 UPC: 687456215983 3. best by: 09/06/2025; 10/03/2025; 11/22/2025; 01/18/2026 UPC: 687456923857
Recalling firm:
Riverside Natural Foods, Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
FoodRecalled December 9, 2024

1. MadeGood Chocolate Chip Granola Bars 34oz (40 bars) 2. MadeGood Chocolate Chip Granola Bars 53.55 oz (63 bars) 3. MadeGood Chocolate Chip Granola Bars 5.1oz (6 bars) 4. MadeGood Chocolate Chip Granola Bars 10.2oz (12 bars) 5. MadeGood Chocolate Chip Granola Bars 20.4oz (24 bars) 6. MadeGood Chocolate Chip Granola Bars 5.1oz (6 bars) 7. MadeGood Chocolate Chip Granola Bars 0.85oz

May contain metal pieces

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-0536-2025
Lot/product code:
1. UPC: X002FK5HCF; Best by: 05/03/2025 up to and including 12/06/2025 2. UPC:10687456216055 Best by: 08/05/2025; 10/25/2025 3. UPC: 10687456216055; Best by: 08/05/2025; 10/25/2025 4: UPC: 687456213057; Best by: 05/03/2025 up to and including 01/16/2026 and 02/01/2026 5. UPC: 687456214115; Best By: 05/10/2025; 05/11/2025; 06/13/2025; 06/28/2025; 06/29/2025; 07/01/2025; 07/05/2025; 07/06/2025; 07/07/2025; 08/04/2025; 08/05/2025; 09/09/2025; 09/10/2025; 09/22/2025; 09/232025; 10/12/2025; 10/13/2025; 12/19/2025; 12/20/2025; 12/21/2025; 12/22/2025; 01/11/2026; 01/12/2026; 01/13/2026; 02/07/2026; 02/08/2026; 02/21/2026 6. UPC: 687456215587; 05/10/2025 up to and including 02/21/2026 and 02/25/2026 7. UPC: 00687456215792 Best by: 02/01/2026 8. UPC: 687456211091 Best by: 12/12/2024 up to and including 02/21/2026 and also 02/25/2026
Recalling firm:
Riverside Natural Foods, Ltd.
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 6, 2024

Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04

CGMP Deviations: Presence of N-nitroso-duloxetine 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-0155-2025
Lot/product code:
Lot DT3023029A Exp 02/28/2025
Recalling firm:
Amerisource Health Services LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 6, 2024

Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08

CGMP Deviations: Presence of N-nitroso-duloxetine 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-0158-2025
Lot/product code:
Lots, expiry: Lot DT6022166A, exp 11/30/2024; Lot DT6023071A, exp 2/28/2025
Recalling firm:
Amerisource Health Services LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 6, 2024

Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05

CGMP Deviations: Presence of N-nitroso-duloxetine 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-0156-2025
Lot/product code:
Lot DT3023030A Exp 2/28/2025
Recalling firm:
Amerisource Health Services LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 6, 2024

Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.

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-0162-2025
Lot/product code:
Lot # 230077C, exp. date 11/2025
Recalling firm:
Breckenridge Pharmaceutical, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 6, 2024

Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. NDC: 59651-137-30

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) 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-0149-2025
Lot/product code:
Lot #: NB0224001A and NB0224001B, Exp. Date 04/2027
Recalling firm:
Aurobindo Pharma USA Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 6, 2024

Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04

CGMP Deviations: Presence of N-nitroso-duloxetine 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-0157-2025
Lot/product code:
Lot DT6023061B Exp 01/31/2025
Recalling firm:
Amerisource Health Services LLC
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 6, 2024

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.

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-0161-2025
Lot/product code:
Lot # 222205C, exp. date 11/2025
Recalling firm:
Breckenridge Pharmaceutical, Inc
View official FDA record (opens in a new tab)
Class IIModerate risk
DrugRecalled December 4, 2024

Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15.

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-0168-2025
Lot/product code:
Lot # 47101; Exp. 02/2026
Recalling firm:
AvKARE
View official FDA record (opens in a new tab)