PlainRecalls

2016 Recalls

6,806 recalls · Page 69 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 0 critical, 48 moderate, and 2 lower-severity recalls. The page references 6 distinct recalling firms operating in 2 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, 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 Moderate Jul 20, 2016

Lidocaine 2%, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0946-70

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manuf…

Noven Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

MAGNESIUM CHL 200MG/ML (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY

Medaus, Inc.

FDA Drug Moderate Jul 20, 2016

Epinephrine (PF) 10mcg/mL in 0.9% Sodium Chloride, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-…

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

METHYL B12 1000MCG/ML IN NACL 0.9% (PF), 2ML Vials, MEDAUS PHARMACY

Medaus, Inc.

FDA Drug Moderate Jul 20, 2016

HYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals…

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

Epinephrine HCI 5 mcg/mL in 0.9% Sodium Chloride, 10mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-08…

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

LIPO-INJECTION W/LIDOCAINE W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 PO4-5MG, B-3-50MG, B5-5MG, B6-5MG, CYANO B12-100MCG, METHIONIN…

Medaus, Inc.

FDA Drug Moderate Jul 20, 2016

Promethazine 6.25 mg added to 0.9% Sodium Chloride 50 mL in 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN…

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32

Hospira Inc.

FDA Drug Moderate Jul 20, 2016

Morphine Sulfate (PF) 0.5mg/mL in 0.9% Sodium Chloride 1mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN…

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9 hours (1.6 mg/hr), packaged in 30-count patches per box, Rx only, Manuf…

Noven Pharmaceuticals, Inc.

FDA Drug Low Jul 20, 2016

Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for …

Apotex Scientific, Inc

FDA Drug Moderate Jul 20, 2016

FARSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The Peoples Republic of China, remaining labeling contains Chinese characters.

Murray International Trading Co., Inc.

FDA Drug Moderate Jul 20, 2016

Midazolam (PF) 5mg/ml 25 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0138-67

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

B-COMPLEX 50 IN NACL 0.9% W/PRES., (BENZYL ETOH 2%), B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-50MG/ML, 10ML Vials, MEDAUS PHARMACY

Medaus, Inc.

FDA Drug Moderate Jul 20, 2016

MINOXIDIL 0.5% W/PRES. (BENZYL ETOH 2%), 10ML Vials, MEDAUS PHARMACY

Medaus, Inc.

FDA Drug Moderate Jul 20, 2016

HYDROmorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD syringe;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, …

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

Midazolam HCl 1mg/mL in 0.9% Sodium Chloride, 50 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-…

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

Rocuronium 10mg/ml 10ml fill in a 10ml BD syringe; Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0971-72

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

Ephedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0…

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

Hydromorphone HCI 1 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN…

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

Vancomycin HCL 1.25 GM added to 5% Dextrose in a 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45…

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

PYRIDOXAL 50 MG/THIAMINE 50 MG/LIDOCAINE 1% NS (PF), 2ML Vials, MEDAUS PHARMACY

Medaus, Inc.

FDA Drug Moderate Jul 20, 2016

Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 500mL lntravia bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-…

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

Fentanyl Citrate injection, 50 mcg/mL, 50 mL lntravia IV Bag Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0118-…

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

Bupivacaine 1mg/mL injection in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0…

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride 100 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Nobles…

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

Midazolam HCI 1mg/mL in 0.9% Sodium Chloride ,2 mL fill in a 3 mL syringe; Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-…

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

Fentanyl Citrate 50 mcg/ml injection, 2mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183…

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

ARGININE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY

Medaus, Inc.

FDA Drug Moderate Jul 20, 2016

Morphine Sulfate 1mg/mL in 0.9% Sodium Chloride 50 mL fill in a 50 mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesv…

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

Morphine Sulfate 1mg/mL (Preserved) in 0.9% Sodium Chloride, 50 mL lntravia bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC…

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

Phenylephrine HCI100mcg/mL in 0.9% sodium Chloride 10ml fill in a 10mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN …

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

MANGANESE SO4 0.1MG/ML (PF), In a) 2MLVials and b) 10ML Vials, MEDAUS PHARMACY

Medaus, Inc.

FDA Drug Moderate Jul 20, 2016

LIPO #4 W/METHYL B12 500 MCG/ML/NO METHIONINE W/PRES (BENZYL ETOH 2%) ASCORBIC ACID 50MG; B1-50MG;B2-5-P04-5MG;B3-30MG; B5-5MG;B6-5MG;METHYL B12 500…

Medaus, Inc.

FDA Drug Moderate Jul 20, 2016

Fentanyl Citrate 2.5 mcg/mL & Bupivacaine 0.075% in 0.9% Sodium Chloride, 60 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Nobles…

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

Fentanyl Citrate 50 mcg/mL, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0964-70

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

FOLIC ACID 10MG/ML W/PRES. (METHYLPARABEN 0.05%, PROPYLPARABEN 0.025% IN NACL, 10ML Vials, MEDAUS PHARMACY

Medaus, Inc.

FDA Drug Moderate Jul 20, 2016

Atropine Sulfate 0.4mg/mL 2.5 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0867-71

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

HYDROXY B12 5MG/ML IN NACL 0.9% (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY

Medaus, Inc.

FDA Drug Moderate Jul 20, 2016

HYDROXY B12 1000MCG/ML IN NACL 0.9% (PF), 1ML Vials, MEDAUS PHARMACY

Medaus, Inc.

FDA Drug Moderate Jul 20, 2016

LIPO-BOOST W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-52MG, METHYL, B12-500MCG, CARNITINE 50 MG, METHIONINE 12.5MG, INOSITO…

Medaus, Inc.

FDA Drug Low Jul 20, 2016

PYRIDOXINE HCL 100MG/ML W/PRES (BENZYL ETOH 0.02%), 5ML Vials, MEDAUS PHARMACY

Medaus, Inc.

FDA Drug Moderate Jul 20, 2016

NANDROLONE DEC 200MG/ML W/PRES. (BENZYL ETOH 10%), In a) 2ML Vials, b) 4ML Vials, and c) 5ML Vials, MEDAUS PHARMACY

Medaus, Inc.

FDA Drug Moderate Jul 20, 2016

HYDROXY B12 5MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY

Medaus, Inc.

FDA Drug Moderate Jul 20, 2016

EDTA DISODIUM 15% (150MG/ML), 20ML Vials, MEDAUS PHARMACY

Medaus, Inc.

FDA Drug Moderate Jul 20, 2016

HCL 2MG/ML (PF), 5ML Vials, MEDAUS PHARMACY

Medaus, Inc.

FDA Drug Moderate Jul 20, 2016

HYDROmorphone HCI 0.2mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45…

Pharmakon Pharmaceuticals, Inc.

FDA Drug Moderate Jul 20, 2016

Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection in 0.9% Sodium Chloride, 100 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Nob…

Pharmakon Pharmaceuticals, 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: CPSC + NHTSA + USDA FSIS — consumer product, vehicle, and meat/poultry recall feeds for 2016