PlainRecalls

2021 Recall Year Insight

Federal agencies issued 5,231 product recalls indexed by PlainRecalls in calendar year 2021. That represents about 5.01% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 14.3 recalls per day across the FDA, CPSC, USDA FSIS, 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 105 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 2021.

On this page of 50 records, severity classification shows 1 critical, 49 moderate, and 0 lower-severity recalls. The page references 2 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 (50), 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 2021 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, USDA FSIS, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Drug Critical Jun 2, 2021

NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-330-01

Acella Pharmaceuticals, LLC

FDA Drug Moderate Jun 2, 2021

AcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets Rx only NDC 23155-287-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Corgard (nadolol tablets, USP) 40 mg 100 Tablets Rx only NDC 27505-101-01 Distributed by US WorldMeds, LLC, Louisville, KY 40241

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only NDC 47781-306-01 Manufactured by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 Distributed by: Alvogen, Inc. Parsippany, NJ 07054 U.S.A.

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

PHENTERMINE HCL 30MG 100 C4; NDC/UPC 10702002801; RX; CAPSULES

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Nadolol Tablets, USP 40 mg 100 Tablets Rx Only NDC 69097-868-07 Manufactured for: Cipla USA Inc. 9100 S. Dadeland Blvd., Suite 1599 Miami, FL 33156

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Enalapril Maleate Tablets, USP 2.5 mg 100 tablets Rx only Distributed by: Cardinal Health, NDC 64679-923-02

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Meloxicam Tablets, USP 7.5 mg 100 Tablets Rx Only NDC 69097-158-07 Manufactured for: Cipla USA, Inc. 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

ENOXAPARIN DOFIUM INJRVYION, UPD 150MG/1ML 10X1ML SINGLE DOSE SYRINGES; NDC/UPC 60505-0798-4; RX; SYRINGES

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Steglatro (ertugliflozin) tablets 15 mg 30 Tablets Rx only NDC 0006-5364-03 Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL OINTMENT 28GM ; NDC/UPC 0536-1211-95; OTC; OINTMENT

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

VIMPAT(lacosamide) Tablets ,100 mg, 60-count bottle; Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Narcan (naloxone HCl) Nasal Spray 4 mg Two Pack This box contains two (2) 4-mg doses of naloxone HCl in 0.1 mL of nasal spray. 0.1 mL intranasal spray per unit For use in the nose only Rx only NDC 69547-353-02 Distributed by Adapt Pharma, Inc. Radnor, PA 19087 USA

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) 100 mcg/62.5 mcg/25 mcg; 1 ELLIPTA Inhaler containing 30 doses (60 blisters total) Rx Only NDC 0173-0887-10 GlaxoSmithKline Research Triangle Park, NC 27709

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Auryxia (ferric citrate) tablets 210 mg* 200 Tablets Rx Only NDC 59922-631-01 Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc. 750 Lexington Avenue, 20th Floor New York, NY 10022 USA

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Benztropine Mesylate Tablets, USP in all pack sizes, styles and strengths Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Levalbuterol tartrate HFA Inhalation Aerosol 45 mcg/actuation 200 Metered Inhalations Net Contents: 15 g Rx Only NDC 0591-2927-54 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-025-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612 USA

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Sulindac Tablets, USP, 200mg 100-count bottles, Rx Only, Manufactured by: Epic Pharma, LLC, Laurelton, NY 11413, NDC 42806-011-01

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

VITAMIN D3 25MCG 180 TABLETS; NDC/UPC 880681168011; OTC; TABLETS

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Rectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only 30 g Rx Only NDC 58914-301-80 Mfd. by: Pharbil Waltrop GmbH, Im Wirrigen 25, 45731 Waltrop, Germany Distributed by: Aptalis Pharma US, Inc. Birmingham, AL 35242

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

INVEGA SUSTENNA 156MG/1ML; NDC/UPC 50458056301; RX; SYRINGES

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Lamotrigine Extended-Release Tablets 250 mg 30 Tablets Rx Only NDC 49884-604-11 Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Zhejiang 317024 China For Par Pharmaceutical Companes, Inc. Spring Valley, NY 10977 U.S.A.

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Norvir Ritonavir Tablets 100 mg 30 Tablets Rx only NDC 0074-3333-30 Abbott Laboratories North Chicago, IL 60064, U.S.A.

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only ; Rx only Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY ,10017NDC 0069-0469-56

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser (sodium sulfacetamide 9.8% and sulfur 4.8%) Net Wt. 10 oz. (285 g) Rx Only NDC 50096-502-10 Manufactured for: Rosemar Labs, LLC 2100 West Loop South Suite 900 Houston, TX 77027

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Arnuity Ellipta (fluticasone furoate inhalation powder) 200 mcg 1 Ellipta Inhaler containing 1 Foil Strip of 30 Blisters Rx Only NDC 0173-0876-10 GlaxoSmithKline Research Triangle Park, NC 27709

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

IBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML ; NDC/UPC 59651-032-12; RX; SUSPENSION (NO DROPS)

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

SILADRYL 12.5/5ML 118ML SF AF; NDC/UPC 354838135404; OTC; LIQUID

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Hydrocortisone Ointment USP 1% Maximum Strength Net Wt. 1 oz (28 g) NDC 0472-0345-56 Manufactured by: Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28902

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

CYANOCOBAL Injection 1000MCG/ML 25X1ML; NDC/UPC 69680-112-25; RX; MULTI DOSE VIAL

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

TIROSINT(levothyroxine sodium) capsules 175MCG 3 blisters X10 capsules; NDC/UPC 71858-0055-4; RX; CAPSULES

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Benzoyl Peroxide 2.5% Aqueous Base, Acne Treatment Gel Net Wt. 2.1 oz (60 g) NDC 45802-101-96 Distributed By Perrigo Allegan, MI 49010

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

NAT B VIT D3 2000U 100; NDC/UPC 079854041125; OTC; TABLETS

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

RESTASIS 0.05%30X 0.4ML OPTH PF; NDC/UPC 23916330; RX; DROPS/Restasis 0.05% 60x0.4 mL OPTH PF; NDC/UPC 23916330; RX

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Children's Loratadine Oral Solution USP, 5 mg/5 mL (Antihistamine) Allergy Grape Flavor 4 FL OZ (120 mL) NDC 51672-2131-8 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Banzel (rufinamide) tablets 200 mg 120 tablets Rx only NDC 62856-582-52 Manufactured by Eisai Co., Ltd. Marketed by Eisai Inc. Woodcliff Lake, NJ 07677

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

PHENTERMINE HCL 37.5MG 100 C4; NDC/UPC 10702002901; RX; CAPSULES

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Polyethylene Glycol 3350 Powder for Solution, Laxative Net Wt 4.1 oz (119 g) 7 Once-Daily Doses NDC 45802-868-01 Distributed by Perrigo Allegan, MI 49010

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 100 Capsules NDC 75834-020-01 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

OFLOXACIN 0.3% 5ML OPTH; NDC/UPC 17478071310; RX; DROPS

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Colcrys (colchicine, USP) tablets 0.6 mg 30 tablets Rx only Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015,NDC 64764-119-07

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 12 Capsules NDC 75834-020-12 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827 USA

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

ESZOPICLONE 3MG 100 C4; NDC/UPC 65862096901; RX; TABLETS

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Valsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC 59746-360-30 Manufactured by: Jubilant Generics Ltd. Roorkee-247661, India

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Collagenase Santyl Ointment 250 units/g 30 grams Rx Only Marketed by Smith & Nephew, Inc., Fort Worth, TX 76107, NDC 50484-010-30

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Benzoyl Peroxide 10% Acne Medication Wash Net Wt 5 oz (142 g) Distributed By Perrigo Allegan, MI 49010, NDC 45802-318-01

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

LYRICA (pregabalin) capsules, 200mg 90-count bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, MADE IN SINGAPORE

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules 1 A Day Nutritional Supplement NDC 52747-200-30 Marketed by US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036

Cardinal Health Inc.

FDA Drug Moderate Jun 2, 2021

VITAMIN D3 50MCG 100 CALC; NDC/UPC 880681170007; OTC; TABLETS

Cardinal Health Inc.

Nearby Recall Years

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

Compare 2021 with 2020 →

Data Sources

  • Source: FDA openFDA Enforcement API - calendar-year recall filings for food, drugs, and devices
  • Source: USDA FSIS Recalls - calendar-year meat, poultry, and processed egg product recall filings
  • Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2021

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS and NHTSA recall records; no number is typed in by an editor. Figures cover calendar year 2021 across the FDA, CPSC, USDA FSIS 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 September 2026.