FDA enforcement

FDA recalls

Browse 86,532 U.S. Food & Drug Administration product recalls and enforcement actions, by company.

Ajanta Pharma Ltd. — Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, …Class II · 2026-04-29
Ajanta Pharma Ltd. — Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Mar…Class II · 2026-04-29
Ajanta Pharma Ltd. — Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Mar…Class II · 2026-04-29
Ajanta Pharma USA Inc — Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Aj…Class II · 2026-05-27
Ajanta Pharma USA Inc — Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured…Class II · 2026-05-28
AJC International, Inc. — Early Dawn; Whole Tilapia IQF, Gutted & Scaled, Farm Raised, 40 lbs.;…Class II · 2017-12-22
AJI MORI SAUCE CORP — AJI MORI***CHILLIMAMI SAUCE***UMAMI BOMB***NET WT. 250ml. Packaged in…Class II · 2024-02-29
Ajinomoto Foods North America Inc. — Item 5650173 Trader Joe's Japanese Style Fried Rice with Edamame, Tof…Class II · 2026-03-03
Ajinomoto Foods North America Inc. — Item 5650233 Trader Joe's Vegetable Fried Rice, net wt. 1lb per bag. …Class II · 2026-03-03
Ajinomoto Foods North America Inc. — Item 5650883 Ajinomoto Teppanyaki Style Vegetable Fried Rice - Japane…Class II · 2026-03-03
Ajinomoto Foods North America Inc. — Item 5650893 Ajinomoto Japanese-Style Vegetable Fried Rice made with …Class II · 2026-03-03
Ajinomoto Foods North America Inc. — Item 5654390 Ajinomoto Golden Tiger Vegetable Fried Rice - Long grain…Class II · 2026-03-03
Ajinomoto Foods North America Inc. — Item 81097 Ajinomoto Ling Ling Restaurant Style Fried Rice Savory Veg…Class II · 2026-03-03
Ajinomoto Foods North America Inc. — Item 81146 Ajinomoto Tai Pei Shrimp Fried Rice - Shrimp, vegetables &…Class II · 2026-03-03
Ajinomoto Foods North America Inc. — Item 81153 Kroger Chinese Inspiration Vegetable Fried Rice - Blend of…Class II · 2026-03-03
Ajinomoto Foods North America Inc. — Item 6430093 Ajinomoto Green Gyoza Vegetable & Edamame Dumplings 12ct…Class II · 2026-03-03
Ajinomoto Foods North America Inc. — Item 6430143 Ajinomoto Vegetable Gyoza Dumplings 12ct. Net wt. 8.92oz…Class II · 2026-03-03
Ajinomoto Foods North America Inc. — Item 6430153 Ajinomoto Vegetable Gyoza Dumplings. Net wt. 24.7oz. per…Class II · 2026-03-03
AJINOMOTO WINDSOR INC — Posada Hatch Green Chile & Cheese Burrito, 72/4.5 oz burritos per caseClass II · 2018-10-19
AJINOMOTO WINDSOR INC — Allsup's Hatch Green Chile & Cheese Burrito, 72/4.5 oz burritos per c…Class II · 2018-10-19
Ajinomoto Windsor Inc., Golden Tiger Plant — Molly's Kitchen Hotzzarella Cheese Sticks, 12 lbs., Item No. 582648; …Class II · 2016-07-14
Ajinomoto Windsor Inc., Golden Tiger Plant — WAHOO-BATTERED VEGGIE FRIES, 6/2 lb. bags, Product # 229650Class II · 2016-05-06
Ajinomoto Windsor Inc., Golden Tiger Plant — Battered Corn Nugget, Net Wt. 32oz (2lbs) 907g, 6/2lb bags, 4/3lb bag…Class II · 2016-05-06
Ajinomoto Windsor Inc., Golden Tiger Plant — BATTERED SWEET CORN NUGGET, 6/2 lb. bags, Product # 241550, 672685Class II · 2016-05-06
Ajinomoto Windsor Inc., Golden Tiger Plant — SPICY BREADED CORN NUGGET w/JALAPENO, 6/2 lb. bags, Product # 241720,…Class II · 2016-05-06
Ajinomoto Windsor Inc., Golden Tiger Plant — MOLLYS KITCHEN BATTERED VEGETABLE STICKS, 6/2 lb. bags, Product # 673…Class II · 2016-05-06
Ajinomoto Windsor Inc., Golden Tiger Plant — TAI PEI GARDEN VEGETABLE RICE, Net Wt. 18oz (510g), 8/18 oz. pails, P…Class II · 2016-05-06
Ajinomoto Windsor Inc., Golden Tiger Plant — TAI PEI PDQ SHRIMP FRIED RICE, Net Wt. 12 oz (340g), 9/12 oz. pails, …Class II · 2016-05-06
Ajinomoto Windsor Inc., Golden Tiger Plant — TAI PEI SHRIMP FRIED RICE, 8/12 oz. pails, Product # 7007700806Class II · 2016-05-06
Ajinomoto Windsor Inc., Golden Tiger Plant — VIP-CORN CUT, Net Wt. 32 oz (2lbs) 907g, 12/32 oz., 12/16 oz., Produc…Class II · 2016-05-06
Ajinomoto Windsor Inc., Golden Tiger Plant — VIP-QP PETITE PEAS, 12/16 oz., Product # 7007701065Class II · 2016-05-06
Ajinomoto Windsor Inc., Golden Tiger Plant — VIP-STEAMWORKS ORGANIC SWEET CORN, 6 pk./24 oz., Product # 7007706448Class II · 2016-05-06
Ajinomoto Windsor Inc., Golden Tiger Plant — VIP-STEAMWORKS ORGANIC PEAS, 6 pk./24 oz., Product # 7007706464Class II · 2016-05-06
Ajinomoto Windsor Inc., Golden Tiger Plant — VIP-STEAMWORKS ORGANIC MIXED VEGEGETABLES, 6 pk./24 oz., Product # 70…Class II · 2016-05-06
Ajinomoto Windsor Inc., Golden Tiger Plant — VIP-STEAMWORKS SWEET CUT CORN, 12 pk./12 oz., Product # 7007706548Class II · 2016-05-06
Ajinomoto Windsor Inc., Golden Tiger Plant — VIP-STEAMWORKS MIX VEGETABLES, 12 pk./12 oz., Product # 7007706576Class II · 2016-05-06
Ajinomoto Windsor Inc., Golden Tiger Plant — OLD PARK SOUTHWEST VEGETABLE SPRING ROLL, 162 ct./1.5 oz., Product # …Class II · 2016-05-06
Ajinomoto Windsor Inc., Golden Tiger Plant — 1. AJINOMOTO VEGETABLE FRIED RICE, Net Wt. 27 lb (9 ct./3 lb. bags.)…Class II · 2016-05-06
Ajinomoto Windsor Inc., Golden Tiger Plant — Toasted Onion Battered Green Beans, Net Wt. 12lb (5.44kg), 6/2 lb. ba…Class II · 2016-05-06
Ajinomoto Windsor Inc., Golden Tiger Plant — Molly's Kitchen Battered Green Beans, 6/2 lb. bags., Product # 671850Class II · 2016-05-06
AJR TRADING LLC — bio aaa Alcohol en Gel Antibacterial, Alcohol al 70% Cont. Neto 480 m…Class II · 2020-09-03
Aju Pharm Co., Ltd. — Fixone Hybrid AnchorClass II · 2025-12-17
Aju Pharm Co., Ltd. — Fixone Biocomposite AnchorClass II · 2025-12-17
Aju Pharm Co., Ltd. — Genesis Screw-In AnchorClass II · 2025-12-17
Aju Pharm Co., Ltd. — Genesis Dual Thread Screw-In AnchorClass II · 2025-12-17
Aju Pharm Co., Ltd. — Genesis Knotless AnchorClass II · 2025-12-17
Aju Pharm Co., Ltd. — Genesis Push-In Suture AnchorClass II · 2025-12-17
Aju Pharm Co., Ltd. — AlternatiV+ Max Knotless AnchorClass II · 2025-12-17
Aju Pharm Co., Ltd. — AlternatiV+ Screw-In AnchorClass II · 2025-12-17
Akcea Therapeutics, Inc. — Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solutio…Class I · 2022-05-23
Akebia Therapeutics dba Keryx Biopharmaceutials, Inc — Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only,…Class II · 2020-12-09
Akebia Therapeutics dba Keryx Biopharmaceutials, Inc — Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONL…Class III · 2021-01-29
Akita Sumitomo Bakelite Co., Ltd. — SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M…Class II · 2016-09-09
Akita Sumitomo Bakelite Co., Ltd. — SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Leng…Class II · 2016-09-09
Akorn Inc — Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bott…Class II · 2016-10-21
Akorn Inc — Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 a…Class II · 2016-11-14
Akorn Inc — Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-co…Class III · 2017-12-15
Akorn Inc — COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% …Class III · 2018-12-20
Akorn Inc — Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose…Class II · 2019-02-04
Akorn Inc — Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-27…Class III · 2019-01-25
Akorn Inc — Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg…Class II · 2017-03-13
Akorn Inc — Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bott…Class II · 2019-12-16
Akorn Inc — Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper …Class II · 2019-03-12
Akorn Inc — Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) un…Class III · 2017-07-12
Akorn Inc — Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.1…Class III · 2017-07-12
Akorn Inc — Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.1…Class III · 2017-07-12
Akorn Inc — Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules…Class III · 2019-04-23
Akorn Inc — Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules…Class III · 2020-03-25
Akorn Inc — Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of …Class III · 2019-06-07
Akorn, Inc — PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Onl…Class II · 2022-08-01
Akorn, Inc — Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dos…Class III · 2022-08-08
Akorn, Inc. — Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), …Class II · 2021-10-04
Akorn, Inc. — AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic O…Class II · 2022-10-13
Akorn, Inc. — Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8…Class II · 2022-10-13
Akorn, Inc. — Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4…Class II · 2022-10-13
Akorn, Inc. — Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), …Class II · 2022-10-13
Akorn, Inc. — Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5m…Class II · 2022-10-13
Akorn, Inc. — Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only…Class II · 2022-10-13
Akorn, Inc. — ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) …Class II · 2022-10-13
Akorn, Inc. — Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube …Class II · 2022-10-13
Akorn, Inc. — GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL…Class II · 2022-10-13
Akorn, Inc. — Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 m…Class II · 2022-10-13
Akorn, Inc. — Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Man…Class II · 2022-10-13
Akorn, Inc. — Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC…Class II · 2022-10-13
Akorn, Inc. — Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle,…Class II · 2022-10-13
Akorn, Inc. — Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Oin…Class II · 2022-10-13
Akorn, Inc. — Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Ma…Class II · 2022-10-13
Akorn, Inc. — Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bott…Class II · 2022-10-13
Akorn, Inc. — Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redn…Class II · 2022-10-13
Akorn, Inc. — Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx …Class II · 2022-10-13
Akorn, Inc. — Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per …Class II · 2022-10-13
Akorn, Inc. — Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx On…Class II · 2022-10-13
Akorn, Inc. — PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solu…Class II · 2022-10-13
Akorn, Inc. — Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per d…Class II · 2022-10-13
Akorn, Inc. — Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per b…Class II · 2022-10-13
Akorn, Inc. — Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.)…Class II · 2022-10-13
Akorn, Inc. — Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL …Class II · 2022-10-13
Akorn, Inc. — Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, R…Class II · 2022-10-13
Akorn, Inc. — Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, …Class II · 2022-10-13
Akorn, Inc. — Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx …Class II · 2020-12-28