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, 47 moderate, and 2 lower-severity recalls. The page references 22 distinct recalling firms operating in 4 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, 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 Moderate Aug 25, 2021

Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-022-85 ; packaged in tubes.

Teligent Pharma, Inc.

FDA Drug Moderate Aug 25, 2021

Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01

Teva Pharmaceuticals USA

FDA Drug Moderate Aug 25, 2021

Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.

Teva Pharmaceuticals USA

FDA Drug Moderate Aug 25, 2021

Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11

Teva Pharmaceuticals USA

FDA Drug Moderate Aug 25, 2021

Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-0525-2; b) 8 Systems NDC 68968-0525-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186

Noven Pharmaceuticals Inc

FDA Drug Moderate Aug 25, 2021

Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-5145-91

Teva Pharmaceuticals USA

FDA Drug Moderate Aug 25, 2021

Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3311-01

Teva Pharmaceuticals USA

FDA Drug Moderate Aug 25, 2021

Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3301-01

Teva Pharmaceuticals USA

FDA Drug Moderate Aug 25, 2021

GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, USA Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-060-19

Novel Laboratories, Inc. d.b.a LUPIN

FDA Drug Moderate Aug 25, 2021

Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7133-01), Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454.

Teva Pharmaceuticals USA

FDA Drug Moderate Aug 25, 2021

Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5140-01

Teva Pharmaceuticals USA

FDA Drug Moderate Aug 25, 2021

Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR 72716, NDC 79903-052-10

Spirit Pharmaceuticals

FDA Drug Moderate Aug 25, 2021

Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in the USA for: NorthStar Rx LLC Memphis, TN 38141, NDC 16714-180-01

Teva Pharmaceuticals USA

FDA Drug Low Aug 25, 2021

Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711

DuPont Nutrition USA, Inc

FDA Drug Moderate Aug 25, 2021

Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0703-9040-01

Teva Pharmaceuticals USA

FDA Drug Moderate Aug 25, 2021

Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC 0703-1501-02), Rx only, Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Vial NDC 0703-1501-01

Teva Pharmaceuticals USA

FDA Drug Moderate Aug 25, 2021

Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-4502-01

Teva Pharmaceuticals USA

FDA Drug Moderate Aug 25, 2021

Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01

Teva Pharmaceuticals USA

FDA Drug Moderate Aug 25, 2021

Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx only, Manufactured by: Teva Pharmaceuticals USA Inc. Parsippany, NJ 07054, NDC 0703-8776-01

Teva Pharmaceuticals USA

FDA Drug Moderate Aug 25, 2021

Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05

Zydus Pharmaceuticals (USA) Inc

FDA Drug Moderate Aug 25, 2021

Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle, Manufactured by: High Performance Formulas, L.L.C. (HPF, L.L.C.) P.O. Box 1311, Morrisville, PA 19067, UPC 640485-10093-4

High Performance Formulas, L.L.C. (HPF, L.L.C.)

FDA Devices Moderate Aug 25, 2021

CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,

Ortho8, Inc.

FDA Devices Moderate Aug 25, 2021

NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units

Delta Med SpA

FDA Devices Moderate Aug 25, 2021

Trilogy Evo Universal, Product number DS2000X11B

Philips Respironics, Inc.

FDA Devices Moderate Aug 25, 2021

Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B

Philips Respironics, Inc.

FDA Devices Moderate Aug 25, 2021

TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)

Boston Scientific Corporation

FDA Devices Moderate Aug 25, 2021

Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT050010 UDI: (01)00733132606320 HPT050010A UDI: (01)00733132606337

W L Gore & Associates, Inc.

FDA Devices Moderate Aug 25, 2021

728333 Spectral CT 7500 -Computed Tomography X-ray system

Philips North America Llc

FDA Devices Moderate Aug 25, 2021

728332 IQon Spectral CT-Computed Tomography X-ray system

Philips North America Llc

FDA Devices Moderate Aug 25, 2021

NEO DELTA Self Safe, I.V. Catheter REF 3738222

Delta Med SpA

FDA Devices Moderate Aug 25, 2021

728327 Ingenuity CT Upgrades-Computed Tomography X-ray system

Philips North America Llc

FDA Devices Moderate Aug 25, 2021

NEO DELTA SELFSAFE PUR T, I.V. Catheter:

Delta Med SpA

FDA Devices Moderate Aug 25, 2021

728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades

Philips North America Llc

FDA Devices Moderate Aug 25, 2021

RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095

Teleflex Medical Europe Ltd

FDA Devices Moderate Aug 25, 2021

NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile

Epimed International

FDA Devices Moderate Aug 25, 2021

OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004

OPTI Medical Systems, Inc

FDA Devices Moderate Aug 25, 2021

RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF numbers: a) 112082050 b) 112082055 c) 112082060 d) 112082065 e) 112082070 f) 112082075 g) 112082080 h) 112082085 i) 112082090 j) 112082095 k) 112082100

Teleflex Medical Europe Ltd

FDA Devices Critical Aug 25, 2021

Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201

Cardinal Health 200, LLC

FDA Devices Moderate Aug 25, 2021

NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522

Delta Med SpA

FDA Devices Moderate Aug 25, 2021

DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572

Delta Med SpA

FDA Devices Moderate Aug 25, 2021

NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822

Delta Med SpA

FDA Devices Moderate Aug 25, 2021

WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W

Delta Med SpA

FDA Devices Moderate Aug 25, 2021

Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)

Cytocell Ltd.

FDA Devices Moderate Aug 25, 2021

The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 mm Height 14 mm Eccentric LOW (1.5) Material PyC/CoCr, b) Catalog # DWH041 - Diameter 41 m m Height 15 mm Eccentric LOW (1.5) Material PyC/CoCr, c) Catalog # DWH043 - Diameter 43 mm Height 16 mm Eccentric LOW (1.5) Material PyC/CoCr, d) Catalog # DWH046 - Diameter 46 mm Height 17 mm Eccentric LOW (1.5) Material PyC/CoCr, e) Catalog # DWH048 - Diameter 48 mm Height 18 mm

Tornier S.A.S.

FDA Devices Low Aug 25, 2021

Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16

Cell Marque Corporation

FDA Devices Moderate Aug 25, 2021

RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF numbers: a) 112080050 b) 112080055 c) 112080060 d) 112080065 e) 112080070 f) 112080075 g) 112080080 h) 112080085 i) 112080090 j) 112080095 k) 112080100

Teleflex Medical Europe Ltd

FDA Devices Moderate Aug 25, 2021

Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT060015 UDI: (01)00733132606368 HPT060015A UDI: (01)00733132606375

W L Gore & Associates, Inc.

FDA Devices Moderate Aug 25, 2021

Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B

Philips Respironics, Inc.

FDA Devices Moderate Aug 25, 2021

Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures

Hitachi Healthcare Americas Corporation

FDA Devices Moderate Aug 25, 2021

NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile

Epimed International

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.