PlainRecalls

2023 Recalls

6,617 recalls · Page 126 of 133

2023 Recall Year Insight

Federal agencies issued 6,617 product recalls indexed by PlainRecalls in calendar year 2023. That represents about 6.51% of the 101,704 total recalls we track from 1995 through the present, and averages roughly 18.1 recalls per day across the FDA, CPSC, and NHTSA combined. Year-level views are the cleanest way to see macro patterns: volume spikes often correlate with new regulatory priorities (e.g., infant-sleep products after 2021, lithium-ion batteries after 2022), supply-chain contamination events, or changes in agency enforcement intensity, while quiet years can reflect either genuine product-safety improvements or reduced agency staffing and reporting lag. With 133 pages at 50 recalls each, browsing this year end-to-end gives a statistically representative sample of what the federal recall pipeline looked like in 2023.

On this page of 50 records, severity classification shows 0 critical, 44 moderate, and 6 lower-severity recalls. The page references 14 distinct recalling firms operating in 3 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Drug (29), FDA Devices (21), which matters because each agency's recall authority, hazard framing, and remedy mechanism differ, an FDA food recall, a CPSC consumer-product recall, and a NHTSA vehicle recall are legally distinct instruments even when the underlying hazard language sounds similar. Reviewing the dominant agency for a given year is one of the fastest ways to understand where federal attention was concentrated.

Year-indexed browsing serves three practical purposes: historical research (tracking how a hazard class evolved over time), consumer action (finding whether a product purchased in 2023 was later recalled), and journalistic or regulatory context (understanding what the enforcement landscape looked like in a given period). Every record on this page links to a full detail view with the hazard, remedy, distribution, and agency-assigned recall number, always use that recall number to verify current status directly with the issuing agency before acting on time-sensitive remedies, because agencies amend, terminate, and expand recalls in the months and years after initial publication. Data on this page reflects federal agency public filings; the agency's live record remains authoritative for legal, medical, or safety decisions. Verify with FDA openFDA, CPSC, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Drug Moderate Jan 25, 2023

Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-290-10

Akorn, Inc.

FDA Drug Low Jan 25, 2023

Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by: Lannett Company, Inc.…

Lannett Company Inc.

FDA Drug Moderate Jan 25, 2023

Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-305-12

Akorn, Inc.

FDA Drug Moderate Jan 25, 2023

Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-62…

Akorn, Inc.

FDA Drug Moderate Jan 25, 2023

Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Inc…

Akorn, Inc.

FDA Drug Moderate Jan 25, 2023

Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufactured by: Akorn, Inc., Lake For…

Akorn, Inc.

FDA Drug Moderate Jan 25, 2023

Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL…

Akorn, Inc.

FDA Drug Moderate Jan 25, 2023

Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by: Akorn, Inc., Lake …

Akorn, Inc.

FDA Drug Moderate Jan 25, 2023

Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Distribute…

Akorn, Inc.

FDA Drug Moderate Jan 25, 2023

Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton ND…

Amerisource Health Services LLC

FDA Drug Moderate Jan 25, 2023

Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, Manufactured by: Akorn, INC., La…

Akorn, Inc.

FDA Drug Moderate Jan 25, 2023

PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only, Manufactured by: Akorn, Inc.…

Akorn, Inc.

FDA Drug Low Jan 25, 2023

SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menlo Park, CA 94025, NDC 10599-0…

Intersect ENT, Inc.

FDA Drug Moderate Jan 25, 2023

AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured by: Akorn, I…

Akorn, Inc.

FDA Drug Moderate Jan 25, 2023

ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 1…

Akorn, Inc.

FDA Drug Moderate Jan 25, 2023

Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles: NDC 17478-288-11; …

Akorn, Inc.

FDA Drug Moderate Jan 25, 2023

Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-291-11

Akorn, Inc.

FDA Drug Moderate Jan 25, 2023

Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-…

Akorn, Inc.

FDA Drug Moderate Jan 25, 2023

Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. …

Akorn, Inc.

FDA Drug Moderate Jan 25, 2023

Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg per mL), …

Fresenius Kabi USA, LLC

FDA Drug Moderate Jan 25, 2023

Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg per mL), 50 …

Fresenius Kabi USA, LLC

FDA Drug Moderate Jan 25, 2023

Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn, Inc., Lake …

Akorn, Inc.

FDA Drug Moderate Jan 25, 2023

Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC…

Akorn, Inc.

FDA Drug Moderate Jan 25, 2023

Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: Akorn, Lake Forest, IL 60045. NDC: 17478-519-19

Akorn, Inc.

FDA Drug Low Jan 25, 2023

Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540; Manufactured by: Macleo…

MACLEODS PHARMA USA, INC

FDA Drug Moderate Jan 25, 2023

Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, Inc., Lake …

Akorn, Inc.

FDA Drug Moderate Jan 25, 2023

Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 67877-260-30; Manufactured by Alkem Laboratories Ltd., India; Distributed b…

Ascend Laboratories, LLC

FDA Drug Moderate Jan 25, 2023

Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL…

Akorn, Inc.

FDA Drug Low Jan 25, 2023

Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by: Lannett Company, Inc., Philadel…

Lannett Company Inc.

FDA Devices Moderate Jan 25, 2023

ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292

Cardinal Health 200, LLC

FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2189

Cardinal Health 200, LLC

FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2233

Cardinal Health 200, LLC

FDA Devices Moderate Jan 25, 2023

Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max

Siemens Medical Solutions USA, Inc

FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2217

Cardinal Health 200, LLC

FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2223

Cardinal Health 200, LLC

FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2227

Cardinal Health 200, LLC

FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2212

Cardinal Health 200, LLC

FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2225

Cardinal Health 200, LLC

FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2190

Cardinal Health 200, LLC

FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187

Cardinal Health 200, LLC

FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2214

Cardinal Health 200, LLC

FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186

Cardinal Health 200, LLC

FDA Devices Low Jan 25, 2023

Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels

Abbott Laboratories

FDA Devices Low Jan 25, 2023

R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N; (2) CBC-3D TRI PACK Hemat…

R & D Systems, Inc.

FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2230

Cardinal Health 200, LLC

FDA Devices Moderate Jan 25, 2023

RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX

Bolton Medical Inc.

FDA Devices Moderate Jan 25, 2023

MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.

Mobius Imaging, LLC

FDA Devices Moderate Jan 25, 2023

RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX

Bolton Medical Inc.

FDA Devices Moderate Jan 25, 2023

Vasoshield Syringe Packs, Model VH-5001

Maquet Cardiovascular, LLC

Nearby Recall Years

Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.

Compare 2023 with 2022 →

Data Sources

  • Source: FDA openFDA Enforcement API - calendar-year recall filings for food, drugs, and devices
  • Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2023

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Figures cover calendar year 2023 across the FDA, CPSC and NHTSA federal recall feeds. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.