PlainRecalls

2021 Recalls

Compiled from official public sources by the editorial team.

5,168 recalls · Page 10 of 104

2021 Recall Year Insight

Federal agencies issued 5,168 product recalls indexed by PlainRecalls in calendar year 2021. That represents about 5.08% of the 101,704 total recalls we track from 1995 through the present, and averages roughly 14.2 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 104 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 8 critical, 41 moderate, and 1 lower-severity recalls. The page references 15 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 Devices (29), FDA Drug (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 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, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Drug Moderate Nov 24, 2021

Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523-4162-1, Product of Finland 8…

Bayer Healthcare Pharmaceuticals Inc.

FDA Drug Critical Nov 24, 2021

LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product o…

Bayer Healthcare Pharmaceuticals Inc.

FDA Drug Moderate Nov 24, 2021

LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Sp…

Bayer Healthcare Pharmaceuticals Inc.

FDA Drug Critical Nov 24, 2021

Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Pro…

Bayer Healthcare Pharmaceuticals Inc.

FDA Drug Moderate Nov 24, 2021

LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Prod…

Bayer Healthcare Pharmaceuticals Inc.

FDA Drug Critical Nov 24, 2021

LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of S…

Bayer Healthcare Pharmaceuticals Inc.

FDA Drug Moderate Nov 24, 2021

LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, packaged as (a) single pack, UPC 0 41100 58720 6, NDC …

Bayer Healthcare Pharmaceuticals Inc.

FDA Drug Critical Nov 24, 2021

Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41000 4, NDC…

Bayer Healthcare Pharmaceuticals Inc.

FDA Drug Moderate Nov 24, 2021

LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Sp…

Bayer Healthcare Pharmaceuticals Inc.

FDA Drug Moderate Nov 24, 2021

LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 58720 6, NDC 11523-0010-2; Dist by: Bayer …

Bayer Healthcare Pharmaceuticals Inc.

FDA Drug Moderate Nov 24, 2021

Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65…

Amneal Pharmaceuticals of New York, LLC

FDA Drug Moderate Nov 24, 2021

Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, (c) Pr…

Bayer Healthcare Pharmaceuticals Inc.

FDA Drug Critical Nov 24, 2021

Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland 200661…

Bayer Healthcare Pharmaceuticals Inc.

FDA Drug Moderate Nov 24, 2021

Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx Only, 90 capsules, labelled as (a) Manufactured By: Teva Pharmaceutical…

Teva Pharmaceuticals USA

FDA Drug Moderate Nov 24, 2021

LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 11523-0544-2 UPC 3 11017 41025 7; (b) 3 …

Bayer Healthcare Pharmaceuticals Inc.

FDA Drug Moderate Nov 24, 2021

Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100 40788 7, NDC 11523-4327-1; (b) 3…

Bayer Healthcare Pharmaceuticals Inc.

FDA Drug Moderate Nov 24, 2021

Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Product of Finland 20006106, (c) Prod…

Bayer Healthcare Pharmaceuticals Inc.

FDA Drug Low Nov 24, 2021

Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT Inc., Salt Lake City, UT, Dist…

Teva Pharmaceuticals USA

FDA Drug Moderate Nov 24, 2021

Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Ireland 869519…

Bayer Healthcare Pharmaceuticals Inc.

FDA Drug Critical Nov 24, 2021

LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, ND…

Bayer Healthcare Pharmaceuticals Inc.

FDA Drug Moderate Nov 24, 2021

Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 6…

Amneal Pharmaceuticals of New York, LLC

FDA Devices Moderate Nov 24, 2021

BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the …

Bio-Rad Laboratories, Inc.

FDA Devices Moderate Nov 24, 2021

SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary …

Cordis Corporation

FDA Devices Moderate Nov 24, 2021

Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075

CooperSurgical, Inc.

FDA Devices Moderate Nov 24, 2021

REGARD Vitrectomy Tray

ROi CPS LLC

FDA Devices Moderate Nov 24, 2021

REGARD Ear Tray

ROi CPS LLC

FDA Devices Moderate Nov 24, 2021

Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes …

Fujifilm Irvine Scientific, Inc.

FDA Devices Moderate Nov 24, 2021

Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of the cobas u 601 urine analyzer…

Roche Diagnostics Operations, Inc.

FDA Devices Moderate Nov 24, 2021

LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220

CooperSurgical, Inc.

FDA Devices Moderate Nov 24, 2021

Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W

CooperSurgical, Inc.

FDA Devices Moderate Nov 24, 2021

LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220

CooperSurgical, Inc.

FDA Devices Moderate Nov 24, 2021

REGARD Basic Cataract tray

ROi CPS LLC

FDA Devices Moderate Nov 24, 2021

SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary …

Cordis Corporation

FDA Devices Moderate Nov 24, 2021

Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434

Medicalplastic S.R.L.

FDA Devices Moderate Nov 24, 2021

Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and…

Cook Inc.

FDA Devices Moderate Nov 24, 2021

bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a com…

Beaver Visitec International, Inc.

FDA Devices Moderate Nov 24, 2021

Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: 373809

Beaver Visitec International, Inc.

FDA Devices Moderate Nov 24, 2021

BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay…

Bio-Rad Laboratories, Inc.

FDA Devices Moderate Nov 24, 2021

LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120

CooperSurgical, Inc.

FDA Devices Moderate Nov 24, 2021

REGARD Newborn Tray

ROi CPS LLC

FDA Devices Moderate Nov 24, 2021

SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary…

Cordis Corporation

FDA Devices Moderate Nov 24, 2021

OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replac…

OmniLife Science

FDA Devices Moderate Nov 24, 2021

bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component-non-sterile sample for eval…

Beaver Visitec International, Inc.

FDA Devices Moderate Nov 24, 2021

REGARD Core Biopsy Tray

ROi CPS LLC

FDA Devices Moderate Nov 24, 2021

REGARD Ultrasound Tray

ROi CPS LLC

FDA Devices Moderate Nov 24, 2021

SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tr…

Cordis Corporation

FDA Devices Critical Nov 24, 2021

Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue

Scrip Inc

FDA Devices Critical Nov 24, 2021

Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous Thrombolytic…

Arrow International Inc

FDA Devices Moderate Nov 24, 2021

REGARD Stereotactic Tray

ROi CPS LLC

FDA Devices Moderate Nov 24, 2021

SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tr…

Cordis Corporation

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: CPSC + NHTSA - consumer product and vehicle recall feeds for 2021

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 2021 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 July 2026.