BIGNOPE
Ko-fi

FDA food · drug · device recalls, merged

Before you eat it, take it, or plug it in — check.

Big Nope pulls three separate FDA recall feeds into one list per state, so you’re not searching three government databases to get one answer.

Just announced

Straight from FDA press releases — not yet formally classified or risk-graded

Recalls nationwide

Data last updated: September 6, 2026 at 10:21 PM UTC

19,229 recalls found
Wording
Class IIILow risk
FoodRecalled July 28, 2026

Honeyville YELLOW COLOR 1 GALLON NFI: WATER, FD&C YELLOW #5, FD&C YELLOW #6, CITRIC ACID, AND SODIUM BENZOATE. MANUFACTURED FOR: HONEYVILLE, INC. RANCHO CUCAMONGA, CA 91730

Not listed on the label Red #40.

Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
H-1225-2026
Lot/product code:
Lot: 60609-8 EXP: 06/08/28
Recalling firm:
FlavorsandColor.Com
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled July 16, 2026

Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7255-68.

Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0737-2026
Lot/product code:
Lot: 25141583, Exp. April 30, 2027.
Recalling firm:
Ascend Laboratories, LLC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled July 16, 2026

Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.

Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0738-2026
Lot/product code:
Lot: 25141585, Exp. April 30, 2027.
Recalling firm:
Ascend Laboratories, LLC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled July 16, 2026

Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Inc., Atlanta, 1750 Corp Dr. Ste 725, Norcross, GA 30093 (844) 903-6418

Incorrect Product Formulation

Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0740-2026
Lot/product code:
Lot #: 20-1535990-0-1 & 20-1535892-0-1, Exp. Date 16 July 2026
Recalling firm:
Central Admixture Pharmacy Services Inc
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled July 16, 2026

Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-04.

Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0739-2026
Lot/product code:
Lot: 25141586, Exp. April 30, 2027.
Recalling firm:
Ascend Laboratories, LLC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled July 15, 2026

Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx Only, Distributed by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-760-01.

Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0713-2026
Lot/product code:
Lot: 070126X1, Exp. 12/31/2027.
Recalling firm:
Asclemed USA Inc.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled July 6, 2026

Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-101-30.

Failed Dissolution Specifications

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0758-2026
Lot/product code:
Lot # 2075801, Exp Date: 31-Oct-2029.
Recalling firm:
Supernus Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled June 30, 2026

Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.

Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0735-2026
Lot/product code:
Lot: 25141707, Exp 4/30/2027.
Recalling firm:
Ascend Laboratories, LLC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled June 30, 2026

Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10.

Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0736-2026
Lot/product code:
Lot: 25141584, Exp 4/30/2027.
Recalling firm:
Ascend Laboratories, LLC
View official FDA record (opens in a new tab)
Class IIILow risk
FoodRecalled June 18, 2026

Kanni Delight 31/40 Fresh Frozen Vannamei White Shrimp IQF, Raw Peeled & Deveined Tail Off, Gross Weight: 5 lb., packaged in polyethylene bags, packed 6 bags per case, Product of India, Farm Raised, for food service only

Nitrofurans detected in product

Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
H-1236-2026
Lot/product code:
Batch: 6D08 Code: 6A14 and Farm Registration Number: TN000643/006 Code: 6A21 and Farm Registration Numbers: TN000643/006, TN000643/007 Code: 6A25 and Farm Registration Number: TN000603/002 Best-by/Expiration Date: April 7, 2028 Approval No. 941
Recalling firm:
CAMPO RICO FOODS LLC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled June 3, 2026

Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01

Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0585-2026
Lot/product code:
Lot AM251676, EXP 11/31/2028
Recalling firm:
Amneal Pharmaceuticals, LLC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled June 2, 2026

hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10

Presence of foreign substance

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0619-2026
Lot/product code:
Lot S25133A
Recalling firm:
ANI Pharmaceuticals, Inc.
View official FDA record (opens in a new tab)
Class IIILow risk
FoodRecalled June 2, 2026

NAUTILUS IMITATION CRAB STICKS NET WT: 1.0 LB (454.0g) UPC: 878665000235 Precooked - serve hot or cold Ingredients: Pollock and/or threadfin bream, water, potato starch, tapioca starch, corn starch, wheat starch, eggs, salt, sugar, mirin (rice wine), soybean oil, soybean protein, crab extract, artificial crab flavor, cochineal color (E-120), paprika color (E-160C). Contains: Fish (Pollock and/or threadfin bream), egg, crustacean shellfish (crab), wheat and soybean. Product of China Packed For: NAUTILUS SEAFOODS WILMINGTON, CA 90744

Not listed on the label sodium tripolyphosphate (STTP)

Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
H-1183-2026
Lot/product code:
Crab Stick: 2406182402HS, 2406262402HS, 2510092507HS, 2603062605JS.
Recalling firm:
Shandong Ling Xian Food Co.,LTD
View official FDA record (opens in a new tab)
Class IIILow risk
FoodRecalled June 2, 2026

Island Pacific IMITATION CRAB FLAKES NET WT: 1.0 LB (454g) UPC: 0000000175012 PRECOOKED SERVE HOT OR COLD INGREDIENTS: POLLOCK AND/OR THREADFIN BREAM, WATER, POTATO STARCH, TAPIOCA STARCH, CORN STARCH, SALT, SUGAR, MIRIN (RICE WINE), SOYBEAN OIL, SOYBEAN PROTEIN, CRAB EXTRACT, ARTIFICIAL CRAB FLAVOR, COLOR ADDED (CARMINE). CONTAINS: FISH (POLLACK AND/OR THREADFIN BREAM), CRUSTACEAN SHELLFISH (CRAB), AND SOYBEAN. PRODUCT OF CHINA ISLAND PACIFIC SUPERMARKET 738 Epperson Drive City of Industry CA 91748

Not listed on the label sodium tripolyphosphate (STTP)

Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
H-1184-2026
Lot/product code:
Crab Flake: 2603062605JS Expiration date for both products: 17/06/2026, 25/06/2026, 08/10/2027, 05/03/2028.
Recalling firm:
Shandong Ling Xian Food Co.,LTD
View official FDA record (opens in a new tab)
Class IIILow risk
FoodRecalled June 2, 2026

Island Pacific IMITATION CRAB STICKS NET WT: 1.0 LB (454g) UPC: 0000000175029 PRECOOKED SERVE HOT OR COLD INGREDIENTS: POLLOCK AND/OR THREADFIN BREAM, WATER, POTATO STARCH, TAPIOCA STARCH, CORN STARCH, SALT, SUGAR, MIRIN (RICE WINE), SOYBEAN OIL, SOYBEAN PROTEIN, CRAB EXTRACT, ARTIFICIAL CRAB FLAVOR, COLOR ADDED (CARMINE). CONTAINS: FISH (POLLACK AND/OR THREADFIN BREAM), CRUSTACEAN SHELLFISH (CRAB), AND SOYBEAN. PRODUCT OF CHINA ISLAND PACIFIC SUPERMARKET 738 Epperson Drive City of Industry CA 91748

Not listed on the label sodium tripolyphosphate (STTP)

Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
H-1182-2026
Lot/product code:
Crab Stick Lot No.: 2412292402HS
Recalling firm:
Shandong Ling Xian Food Co.,LTD
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled June 1, 2026

Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-561-30

Failed Impurities/Degradation Specifications

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0654-2026
Lot/product code:
Lot, expiry: Lot DNG0283A, exp 03/31/2027; Lots DNF0922A and DNF0923B, exp 10/31/2026
Recalling firm:
SUN PHARMACEUTICAL INDUSTRIES INC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled June 1, 2026

Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31

Labeling: Incorrect or Missing Lot and/or Exp Date

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0608-2026
Lot/product code:
Lot VA0099422; Exp. Date June 30, 2028
Recalling firm:
Sandoz Inc
View official FDA record (opens in a new tab)
Class IIILow risk
FoodRecalled May 19, 2026

ESTRELLA, Bebida de Parcha (Passion Fruit Drink), multiple sizes, 14 OZ.FL. (413 ML), 64 OZ.FL (1,920mL), 120 OZ.FL. (3.54LT.) 14 OZ.FL Plastic Bottles packed in cases of 25 bottles. KEEP REFRIGIRATED.

Not listed on the label FD&C Red 40

Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
H-0913-2026
Lot/product code:
May Production Lot Code:12426, 13126, 13426. 4/8/2026 Expiration Date: 4/8/2026, 5/8/2026, 6/8/2026, 11/8/2026, 11/8/2026, 14-08-2026, 14-08-2026 April Production Lot Code: 9226, 9626, 9826, 9926, 10326, 10626, 11026, 11126, 11326, 11826, 11926, 12026 Expiration Date:2/7/2026, 6/7/2026, 8/7/2026, 9/7/2026, 13-07-2026, 16-07-2026, 16-07-2026, 20-07-2026, 21-07-2026, 22-07-2026, 23-07-2026, 23-07-2026, 28-07-2026, 29-07-2026 30-07-2026 March Production Lot Code:6126, 6426, 7026, 9926, 8326, 8226, 8626, 9026 Expiration Date: 2/6/2026, 5/6/2026, 11/6/2026, 20-06-2026, 23-06-2026, 24-06-2026, 27-06-2026, 30-06-2026
Recalling firm:
Refresqueria Estrella Inc.
Resolved:
August 18, 2026
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled May 18, 2026

Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. NDC: 55150-164-02

Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0552-2026
Lot/product code:
Lot, expiry: Lot 3LC26029A, exp Feb-2029; Lot 3LC26031A, exp Mar-2029
Recalling firm:
Eugia US LLC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled May 18, 2026

PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10.

Failed Stability Specifications

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0551-2026
Lot/product code:
Lot # 402805, 407596, Exp Date: 08/2026.
Recalling firm:
AbbVie Inc.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled May 14, 2026

Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.

Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0550-2026
Lot/product code:
Lot #: 56841, Expires: 03/2028
Recalling firm:
AVEVA Drug Delivery Systems, Inc.
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled May 14, 2026

Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)

Failed Impurities/Degradations Specifications

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0581-2026
Lot/product code:
Batch # 6133313, 6133314, Exp Date: 06/2026; Batch # 6133315, Exp Date: 07/2026; Batch # 6133682, Exp Date: 09/2026; Batch # 6134812, 6134813, Exp Date: 04/2027.
Recalling firm:
Fresenius Kabi USA, LLC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled May 4, 2026

Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.

Failed Impurities/Degradation Specifications

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0539-2026
Lot/product code:
Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
Recalling firm:
Sagent Pharmaceuticals
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled May 1, 2026

Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0537-2026
Lot/product code:
Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027
Recalling firm:
Amerisource Health Services LLC
View official FDA record (opens in a new tab)
Class IIILow risk
DrugRecalled May 1, 2026

Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

ALL 50 STATES
Full report

A low-risk recall. This product is unlikely to cause any health problems, but it still doesn't meet FDA rules.

Recall #:
D-0536-2026
Lot/product code:
Lot#: 1027583, Exp 09/30/2027
Recalling firm:
Amerisource Health Services LLC
View official FDA record (opens in a new tab)