PlainRecalls

2016 Recalls

6,806 recalls · Page 90 of 137

2016 Recall Year Insight

Federal agencies issued 6,806 product recalls indexed by PlainRecalls in calendar year 2016. That represents about 8.11% of the 83,949 total recalls we track from 1995 through the present, and averages roughly 18.6 recalls per day across the FDA, CPSC, NHTSA, and USDA FSIS 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 137 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 2016.

On this page of 50 records, severity classification shows 27 critical, 23 moderate, and 0 lower-severity recalls. The page references 18 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 (33), FDA Devices (17), 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 2016 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, NHTSA, or USDA FSIS for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Drug Critical Jun 1, 2016

Pink Bikini Strong Formula capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlingt…

Lucy's Weight Loss (dba. Waisted With Lucy)

FDA Drug Critical Jun 1, 2016

Shorts on the Beach capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System…

Lucy's Weight Loss (dba. Waisted With Lucy)

FDA Drug Critical Jun 1, 2016

Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0024-5831-02) and (b) 1 prefilled auto inj…

Sanofi-Aventis U.S. LLC

FDA Drug Moderate Jun 1, 2016

ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for DENTSPLY Professional, York,…

Akorn, Inc.

FDA Drug Critical Jun 1, 2016

African Superman, packaged in BIG BOX (6 small boxes / 8 capsules per box / 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

R Thomas Marketing, LLC

FDA Drug Critical Jun 1, 2016

Tiger King, packaged in BIG BOX (10 small bottles / 10 capsules per bottle / 100 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

R Thomas Marketing, LLC

FDA Drug Critical Jun 1, 2016

LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Productos Naturales Corp., BROOKLYN, NY 11238, www.lipoesculturatreatment.com

Lipo Escultura Corp.

FDA Drug Moderate Jun 1, 2016

OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL …

Fresenius Kabi USA, LLC

FDA Drug Critical Jun 1, 2016

0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerf…

Baxter Healthcare Corp.

FDA Drug Critical Jun 1, 2016

Zhen Gong Fu, packaged in BIG BOX (16 small boxes / 2 capsules per box / 32 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

R Thomas Marketing, LLC

FDA Drug Critical Jun 1, 2016

Black Storm, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

R Thomas Marketing, LLC

FDA Drug Moderate Jun 1, 2016

0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerf…

Baxter Healthcare Corp.

FDA Drug Moderate Jun 1, 2016

Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administration, 4 g Canister, Rx Only, Distributed by: Bryan Corporation, Woburn,…

Lymol Medical

FDA Drug Critical Jun 1, 2016

Avastin (Bevacizumab) 2 mg/0.08 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.

Pacifico National, Inc. dba AmEx Pharmacy

FDA Drug Moderate Jun 1, 2016

OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL …

Fresenius Kabi USA, LLC

FDA Drug Critical Jun 1, 2016

Weekend Prince, packaged in 24 individual cards / 2 capsules per card/ 48 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

R Thomas Marketing, LLC

FDA Drug Critical Jun 1, 2016

Real Skill, packaged in 20 small boxes / 4 capsules per box / 80 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

R Thomas Marketing, LLC

FDA Drug Critical Jun 1, 2016

Mojo Risen, packaged in BIG BOX (24 individual cards / 2 capsules per card/ 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

R Thomas Marketing, LLC

FDA Drug Moderate Jun 1, 2016

Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY 10017, NDC 0049-4910-30.

Pfizer Inc.

FDA Drug Critical Jun 1, 2016

Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.

Pacifico National, Inc. dba AmEx Pharmacy

FDA Drug Critical Jun 1, 2016

Shorts on The Beach Golden Edition by Pink Bikini, 800 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss S…

Lucy's Weight Loss (dba. Waisted With Lucy)

FDA Drug Critical Jun 1, 2016

CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injection Port Chamber 30% Dextrose In…

Baxter Healthcare Corp.

FDA Drug Critical Jun 1, 2016

Black Ant, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

R Thomas Marketing, LLC

FDA Drug Critical Jun 1, 2016

Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compounded drug, CII, IV Use, syringe, Pharm…

Pharmakon Pharmaceuticals

FDA Drug Critical Jun 1, 2016

Germany Niubian, packaged in BIG BOX (10 small boxes / 24 capsules per box / 240 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

R Thomas Marketing, LLC

FDA Drug Critical Jun 1, 2016

Herb Viagra, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

R Thomas Marketing, LLC

FDA Drug Critical Jun 1, 2016

Bigger Longer More Time More Sperms, packaged in BIG BOX (6 small boxes / 6 capsules per small box / 36 capsules), Distributed by: R Thomas Marketing…

R Thomas Marketing, LLC

FDA Drug Critical Jun 1, 2016

Super Hard, packaged in BIG BOX (20 small boxes / 6 capsules per box / 120 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

R Thomas Marketing, LLC

FDA Drug Critical Jun 1, 2016

African Black Ant, packaged in 8 small boxes / 6 capsules per box / 48 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

R Thomas Marketing, LLC

FDA Drug Critical Jun 1, 2016

Bull's Genital, packaged in CASE (10 Cans / 10 capsules per can / 100 capsules),Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

R Thomas Marketing, LLC

FDA Drug Critical Jun 1, 2016

Hard Ten Days, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

R Thomas Marketing, LLC

FDA Drug Critical Jun 1, 2016

Smart Lipo Dietary Supplement capsules, 900 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011

Centro Naturista

FDA Drug Critical Jun 1, 2016

Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011

Centro Naturista

FDA Devices Moderate Jun 1, 2016

American Surgical Cotton Balls-Strung 1/2" Ref Number: 30-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

American Surgical Company

FDA Devices Moderate Jun 1, 2016

Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.

Biomet, Inc.

FDA Devices Moderate Jun 1, 2016

Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.

Accriva Diagnostics Inc., dba ITC, dba Accumetrics

FDA Devices Moderate Jun 1, 2016

American Surgical Policot 1/2" x 1/2" Ref Number: 90-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

American Surgical Company

FDA Devices Moderate Jun 1, 2016

American Surgical Ultracot 15 mm x 15 mm (Glassine) Ref Number: 23-12G Product Usage: Neurosurgical and Nonneurosurgical Sponges

American Surgical Company

FDA Devices Moderate Jun 1, 2016

iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.

Elekta, Inc.

FDA Devices Moderate Jun 1, 2016

American Surgical Ray-Cot 1/2" x 3" Ref Number: 60-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

American Surgical Company

FDA Devices Moderate Jun 1, 2016

PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.

Biomet, Inc.

FDA Devices Moderate Jun 1, 2016

American Surgical Ultracot 70 mm x 10090 mm Ref Number: 23-24 Product Usage: Neurosurgical and Nonneurosurgical Sponges

American Surgical Company

FDA Devices Moderate Jun 1, 2016

American Surgical Americot Blue 1/2" x 1/2" Ref Number: 20-04S Product Usage: Neurosurgical and Nonneurosurgical Sponges

American Surgical Company

FDA Devices Moderate Jun 1, 2016

3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instruments that c…

Synthes (USA) Products LLC

FDA Devices Moderate Jun 1, 2016

American Surgical Americot Blue 3/8" x 2" Ref Number: 20-26S Product Usage: Neurosurgical and Nonneurosurgical Sponges

American Surgical Company

FDA Devices Moderate Jun 1, 2016

Various trauma and sports medicine instruments and implants. Spinal interlaminal fixation orthosis.

Biomet, Inc.

FDA Devices Moderate Jun 1, 2016

Various trauma and sports medicine instruments and implants. Screw, fixation, bone.

Biomet, Inc.

FDA Devices Moderate Jun 1, 2016

American Surgical Uniqcot 1/2" x 1/2" Ref Number: 67-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

American Surgical Company

FDA Devices Moderate Jun 1, 2016

Various trauma and sports medicine instruments and implants. Arthroscope.

Biomet, Inc.

FDA Devices Moderate Jun 1, 2016

Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, …

Stryker Sustainability Solutions

Nearby Recall Years

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

Compare 2016 with 2015 →

Data Sources

  • Source: FDA openFDA Enforcement API — calendar-year recall filings for food, drugs, and devices
  • Source: CPSC + NHTSA + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2016