PlainRecalls

2019 Recalls

7,396 recalls · Page 117 of 148

2019 Recall Year Insight

Federal agencies issued 7,396 product recalls indexed by PlainRecalls in calendar year 2019. That represents about 8.81% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 20.3 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 148 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 2019.

On this page of 50 records, severity classification shows 0 critical, 43 moderate, and 7 lower-severity recalls. The page references 22 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 (26), FDA Drug (24), 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 2019 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 Mar 27, 2019

Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile single use syringe, For IV or IM use, NDC: 42852-828-22 Avella of Houst…

Advanced Pharma Inc.

FDA Drug Moderate Mar 27, 2019

Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-570-30

Aurobindo Pharma USA Inc.

FDA Drug Moderate Mar 27, 2019

Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobind…

Aurobindo Pharma USA Inc.

FDA Drug Moderate Mar 27, 2019

2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile single use syringe, NDC: 42852-011-67 Avella of Houston 9265 Kirby Dr.,…

Advanced Pharma Inc.

FDA Drug Moderate Mar 27, 2019

Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution, 800 mcg/10 mL (80 mcg per mL), 10mL Sterile single use syringe, ND…

Advanced Pharma Inc.

FDA Drug Moderate Mar 27, 2019

Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HCl 0.9% Sodium Chloride, QS, Sterile single use bag, NDC: 42852-401-0…

Advanced Pharma Inc.

FDA Drug Moderate Mar 27, 2019

Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 500 mcg/5 mL (100 mcg per mL), 5mL Sterile single use syringe, NDC: 4…

Advanced Pharma Inc.

FDA Drug Moderate Mar 27, 2019

Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90

Aurobindo Pharma USA Inc.

FDA Drug Moderate Mar 27, 2019

Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectable Solution, Dwell, 10mL Sterile single use syringe, NDC: 42852-725-61 Av…

Advanced Pharma Inc.

FDA Drug Moderate Mar 27, 2019

HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-289-67 …

Advanced Pharma Inc.

FDA Drug Moderate Mar 27, 2019

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulas…

AVKARE Inc.

FDA Drug Moderate Mar 27, 2019

Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only, Manufactured for: Heritage Pharmaceuticals Inc. Made in India, NDC 2315…

Heritage Pharmaceuticals, Inc.

FDA Drug Low Mar 27, 2019

Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets (10 blister cards of 10 tablets each), Rx only, Manufactured in Israel…

Teva Pharmaceuticals USA

FDA Drug Moderate Mar 27, 2019

Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-788…

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

FDA Drug Moderate Mar 27, 2019

Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmac…

Legacy Pharmaceutical Packaging LLC

FDA Drug Moderate Mar 27, 2019

Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC 50268-517-15

AVKARE Inc.

FDA Drug Moderate Mar 27, 2019

Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Phar…

Rising Pharmaceuticals, Inc.

FDA Drug Moderate Mar 27, 2019

Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1,200 mcg/10 mL (120 mcg per mL), Sterile single use syringe, NDC:…

Advanced Pharma Inc.

FDA Drug Moderate Mar 27, 2019

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plains…

Macleods Pharma Usa Inc

FDA Drug Moderate Mar 27, 2019

Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-573-90

Aurobindo Pharma USA Inc.

FDA Drug Moderate Mar 27, 2019

Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile single use syringe, For IV use only, NDC: 42852-829-67 Avella of Hou…

Advanced Pharma Inc.

FDA Drug Moderate Mar 27, 2019

Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90

Aurobindo Pharma USA Inc.

FDA Drug Moderate Mar 27, 2019

Valsartan Tablets 160 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Phar…

Rising Pharmaceuticals, Inc.

FDA Drug Moderate Mar 27, 2019

Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulask…

AVKARE Inc.

FDA Devices Low Mar 27, 2019

Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-C ELECT-PT Product Usage: The Co…

Cook Medical Incorporated

FDA Devices Low Mar 27, 2019

Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog Number GTCFS-65-1-JUG-CELECT-PT Product Usage: The Cook Celect Plat…

Cook Medical Incorporated

FDA Devices Moderate Mar 27, 2019

smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM, REF 713552511

Smith & Nephew, Inc.

FDA Devices Moderate Mar 27, 2019

Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implanta…

ACell, Inc

FDA Devices Moderate Mar 27, 2019

Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters ar…

ConvaTec, Inc

FDA Devices Moderate Mar 27, 2019

CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050

CTL Medical Corporation

FDA Devices Moderate Mar 27, 2019

smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510

Smith & Nephew, Inc.

FDA Devices Moderate Mar 27, 2019

Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical c…

Randox Laboratories Ltd.

FDA Devices Moderate Mar 27, 2019

Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implanta…

ACell, Inc

FDA Devices Moderate Mar 27, 2019

Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duodenal and St…

ConvaTec, Inc

FDA Devices Low Mar 27, 2019

Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-TULIP Product Usage: The Gunther Tulip …

Cook Medical Incorporated

FDA Devices Moderate Mar 27, 2019

Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical c…

Randox Laboratories Ltd.

FDA Devices Moderate Mar 27, 2019

aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates a…

AAP Implantate Ag

FDA Devices Low Mar 27, 2019

Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP Product Usage: The Gunther Tulip Filter impl…

Cook Medical Incorporated

FDA Devices Moderate Mar 27, 2019

Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical c…

Randox Laboratories Ltd.

FDA Devices Moderate Mar 27, 2019

Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-…

Covidien, PLC

FDA Devices Moderate Mar 27, 2019

FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designed for orthopedic surgery and combines suctioning f…

ConvaTec, Inc

FDA Devices Moderate Mar 27, 2019

Dimension Vista 1500, Analyzer, chemistry Model no. 10444801

Siemens Healthcare Diagnostics, Inc.

FDA Devices Low Mar 27, 2019

PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coating …

Agfa N.V.

FDA Devices Low Mar 27, 2019

Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-CELECT-PT Product Usage: The Cook Celect Pla…

Cook Medical Incorporated

FDA Devices Moderate Mar 27, 2019

Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patient…

Fujifilm Medical Systems U.S.A., Inc.

FDA Devices Moderate Mar 27, 2019

Dimension Vista 500, Analyzer, chemistry Model no. 10284473

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Mar 27, 2019

SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general …

Shimadzu Medical Systems Usa Com

FDA Devices Moderate Mar 27, 2019

CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050

CTL Medical Corporation

FDA Devices Moderate Mar 27, 2019

Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are sterile disposable devices intended for use during clini…

ConvaTec, Inc

FDA Devices Moderate Mar 27, 2019

Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general…

CP Medical Inc

Nearby Recall Years

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

Compare 2019 with 2018 →

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 2019