PlainRecalls

2016 Recall Year Insight

Federal agencies issued 8,349 product recalls indexed by PlainRecalls in calendar year 2016. That represents about 8.00% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 22.9 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 167 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 3 critical, 46 moderate, and 1 lower-severity recalls. The page references 8 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 (50), 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, 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 Oct 19, 2016

lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume, Product code 2R3441, NDC 61553-441-80

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174.

Pharmedium Services, LLC

FDA Drug Critical Oct 19, 2016

Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85

The Harvard Drug Group

FDA Drug Moderate Oct 19, 2016

fentaNYL Citrate, 5 mcg per mL, 15 mcg per 3mL, in 0.9% Sodium chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3318.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

succinylcholine Chloride Injection, 20 mg per mL, 100 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3357.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

midazolam HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3196.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

lidocaine HCl, 1%, 10 mg per mL (50 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3106.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

glycopyrrolate, 0.2 mg per mL, 0.6 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3217.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

lidocaine HCl, 1%, 10 mg per 1 mL, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3102.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3119.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

midazolam HCl, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3356.

Pharmedium Services, LLC

FDA Drug Critical Oct 19, 2016

Oasis Dietary Supplement Capsules, 500 mg, 45 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA

Bee Xtreme

FDA Drug Moderate Oct 19, 2016

morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 2 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3259.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA

Leiter's Compounding

FDA Drug Moderate Oct 19, 2016

morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 1 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3017.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials).

Teva Pharmaceuticals USA

FDA Drug Low Oct 19, 2016

Paricalcitol Capsules, 1 mcg, packaged in 30 Capsules (5 x 6) per carton (NDC 60687-106-25); each blister card containing 6 individually blistered capsules (NDC 60687-106-95), Rx only, Distributed by: American Health Packaging, Columbus, OH, 43217.

Amerisource Health Services

FDA Drug Moderate Oct 19, 2016

Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-011-39

Leiter's Compounding

FDA Drug Moderate Oct 19, 2016

lidocaine HCl, 2%, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3110.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, Total Dose 25.005 mcg/1.5 mL Fentanyl Citrate, Content Volume 1.5 mL in 3 mL BD Syringe, Intended for Epidural Use, Rx only, PharMEDium, Product code 2T6228.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

neostigmine Methylsulfate, 1 mg per mL, 2 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3550.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

Brilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-008-35

Leiter's Compounding

FDA Drug Moderate Oct 19, 2016

fentaNYL Citrate, 25 mcg per mL in 0.9% Sodium chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3236.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

labetalol HCl, 5 mg per mL, 20 mg per 4 mL, 4 mL total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3117.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

lidocaine HCl, 0.5%, 5 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3140.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

remifentanil HCl, 50 mcg per mL, 100 mcg per 2 mL, in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3300.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 1 mL in a syringe, Rx only, PharMEDium, Product code 2R3345.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

methadone HCl, 10 mg per mL, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6149.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

HYDROmorphone HCl, 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3352.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1587-50.

Hospira Inc., A Pfizer Company

FDA Drug Moderate Oct 19, 2016

lidocaine HCl, 2%, Preservative Free, Total Volume 2mL, Product code 2R3323, NDC 61553-323-79

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

lidocaine HCl, 1%, 30 mg per 3 mL, 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3104.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

lidocaine HCl, 2%, 40 mg per 2 mL, 2 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3112.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-003-35

Leiter's Compounding

FDA Drug Moderate Oct 19, 2016

fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL, 5mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3306.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Product code 2R3118, NDC 61553-118-40

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3346.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

atropine Sulfate Injection, 0.4 mg per mL, 0.8 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3335.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

ketamine HCl Injection, 50 mg per mL, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3348.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3109.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-007-35

Leiter's Compounding

FDA Drug Moderate Oct 19, 2016

ketamine HCl Injection, 50 mg per mL (100 mg per 2 mL), 2 mL Total Volume in a syringe, Rx only, PharMEDium, For IV Use, Product code 2R3500.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 3 mL in a syringe, Rx only, PharMEDium, Product code 2R3343.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

fentaNYL Citrate, 5 mcg per mL, 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3479.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3301.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3450.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

HEPARIN Sodium Inj. USP, 15,000 USP Heparin Units per 3 mL Injection 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2K1210.

Pharmedium Services, LLC

FDA Drug Moderate Oct 19, 2016

fentaNYL Citrate, 10 mcg per mL (25 mcg per 2.5 mL), in 0.9% Sodium Chloride, 2.5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3424.

Pharmedium Services, LLC

FDA Drug Critical Oct 19, 2016

5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32

B. Braun Medical Inc

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: USDA FSIS Recalls - calendar-year meat, poultry, and processed egg product recall filings
  • Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2016

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 2016 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.