PlainRecalls

2018 Recall Year Insight

Federal agencies issued 7,928 product recalls indexed by PlainRecalls in calendar year 2018. That represents about 7.59% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 21.7 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 159 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 2018.

On this page of 50 records, severity classification shows 1 critical, 47 moderate, and 2 lower-severity recalls. The page references 20 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 Drug (24), FDA Devices (15), FDA Food (11), 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 2018 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 Food Moderate Oct 31, 2018

Fire-Roasted Pineapple Tidbits; Sold in 25 lb. containers. Brand Name: Jon-Lin¿

McCain Foods USA

FDA Food Moderate Oct 31, 2018

Fire-Roasted Rubio's Elote Corn Blend; Sold in 2 lb. containers. Brand Name: Chef Sensations¿

McCain Foods USA

FDA Food Moderate Oct 31, 2018

Fire Roasted 1/2" Diced Poblano Chiles; Sold in 25 lb. containers. Brand Name:Jon-Lin¿

McCain Foods USA

FDA Food Moderate Oct 31, 2018

Fire Roasted 1/2" Diced Red Peppers; Sold in 2 lb. and 25 lb. containers Brand name: Jon-Lin¿

McCain Foods USA

FDA Food Moderate Oct 31, 2018

Fire Roasted 1/2" Diced Yellow Peppers: Sold in 25 lb. Brand Name: Jon-Lin¿

McCain Foods USA

FDA Food Moderate Oct 31, 2018

Lutosa Foodservice Quality Plain Mashed Produced in Belgium 2.5 kg/5.5 lb

Lutosa S.A.

FDA Food Moderate Oct 31, 2018

Fire Roasted Red Pepper Strips: Sold in 20 lb. Brand Name: Jon-Lin¿

McCain Foods USA

FDA Food Moderate Oct 31, 2018

Fire Roasted 1/2" Diced Green Zucchini ; Sold in 25 lb. containers. Brand Name: Jon-Lin¿

McCain Foods USA

FDA Food Moderate Oct 31, 2018

Fire-Roasted Red Jalapeno Slices; Sold in 2 lb. containers. Brand Name: Jon-Lin¿

McCain Foods USA

FDA Food Moderate Oct 31, 2018

Dark Caramelized 3/8" Diced Sweet Onions; Sold in 20 lb. containers. Brand Name:Jon-Lin¿

McCain Foods USA

FDA Food Moderate Oct 31, 2018

Fire Roasted 1/2" Diced Button Mushrooms: Sold in 25 lb. containers. Brand Name: Jon-Lin¿

McCain Foods USA

FDA Drug Low Oct 31, 2018

Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-943-11

Lupin Pharmaceuticals Inc.

FDA Drug Moderate Oct 31, 2018

Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-069-60

LUPIN SOMERSET

FDA Drug Moderate Oct 31, 2018

Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottle, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875518028

Valeant Pharmaceuticals North America LLC

FDA Drug Moderate Oct 31, 2018

Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc., Lake Forest, IL 60045, USA. NDC carton: 0409-3506-01; NDC vial: 0409-3506-11

Pfizer Inc.

FDA Drug Moderate Oct 31, 2018

Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawadi, Pune, India, Mfg for: Heritage Pharmaceuticals Inc. UPC 323155216388, NDC 23155-216-31

Heritage Pharmaceuticals, Inc.

FDA Drug Moderate Oct 31, 2018

Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial, Rx only, 340 West State Street, Unit 9, Athens, OH 45701. NDC 7073197450

RXQ Compounding LLC

FDA Drug Moderate Oct 31, 2018

Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-2776-92

Westlab Pharmacy, Inc. dba Westlab Pharmacy

FDA Drug Moderate Oct 31, 2018

Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0591-3695-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054

Teva Pharmaceuticals USA

FDA Drug Moderate Oct 31, 2018

Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875521011

Valeant Pharmaceuticals North America LLC

FDA Drug Moderate Oct 31, 2018

Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01

Teva Pharmaceuticals USA

FDA Drug Moderate Oct 31, 2018

ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tropicamide 0.0735%, Moxiflox 0.0294%, Ketorolac 0.0147%) 1x 1cc syringe, Westlab Pharmacy, Inc., Gainesville, FL 32607 --- NDC 10002-2579-05

Westlab Pharmacy, Inc. dba Westlab Pharmacy

FDA Drug Moderate Oct 31, 2018

Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 00591-2411-01

Teva Pharmaceuticals USA

FDA Drug Moderate Oct 31, 2018

Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00

RemedyRepack Inc.

FDA Drug Moderate Oct 31, 2018

Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054

Teva Pharmaceuticals USA

FDA Drug Moderate Oct 31, 2018

HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by Lannett Company, Inc., Philadelphia, PA 19154, NDC 54838-502-80.

Lannett Company, Inc.

FDA Drug Moderate Oct 31, 2018

Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00

Westlab Pharmacy, Inc. dba Westlab Pharmacy

FDA Drug Moderate Oct 31, 2018

Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Shionogi Inc., Florham Park, NJ 07932, NDC 59630-575-60

Teva Pharmaceuticals USA

FDA Drug Moderate Oct 31, 2018

Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2720-60

Teva Pharmaceuticals USA

FDA Drug Moderate Oct 31, 2018

Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11

Upsher Smith Laboratories, Inc.

FDA Drug Moderate Oct 31, 2018

PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR (Pioglitazone and metformin HCl extended -release) tablets, 15 mg/1000 mg, packaged in a fiber drum, Application Holder Takeda Pharmaceuticals, U.S.A. Inc. One Takeda Parkway, Deerfield, IL 60015

Teva Pharmaceuticals USA

FDA Drug Low Oct 31, 2018

Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684

Promise Pharmacy LLC

FDA Drug Moderate Oct 31, 2018

Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11

Upsher Smith Laboratories, Inc.

FDA Drug Moderate Oct 31, 2018

Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875519155

Valeant Pharmaceuticals North America LLC

FDA Drug Moderate Oct 31, 2018

Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2412-19

Teva Pharmaceuticals USA

FDA Devices Moderate Oct 31, 2018

3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and nonunions of small bones and small bone fragments.

Synthes (USA) Products LLC

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 ) Product Number:-D36-14623

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.

Nakanishi Inc.

FDA Devices Moderate Oct 31, 2018

APTIO 15000 REFRIGERATED STORAGE MODULE

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number Bl70000027 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.

Medtronic Navigation, Inc.-Littleton

FDA Devices Moderate Oct 31, 2018

APTIO RACK INPUT MODULE

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number:R1112B

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.

Nakanishi Inc.

FDA Devices Moderate Oct 31, 2018

STREAMLAB CORE UNIT / LYNX WITH IOM

Siemens Healthcare Diagnostics, Inc.

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number: -ZZ-0664

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl70000027R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.

Medtronic Navigation, Inc.-Littleton

FDA Devices Critical Oct 31, 2018

CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.

Alcon Research, LTD.

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B

Custom Healthcare Systems, Inc.

FDA Devices Moderate Oct 31, 2018

CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C

Custom Healthcare Systems, Inc.

Nearby Recall Years

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

Compare 2018 with 2017 →

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 2018

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 2018 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.