Hydrocodone Acetaminophen Recalls

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There have been five major recalls of hydrocodone acetaminophen since 2012. Each has affected over 4,000 bottles of the generic drug, with the biggest involving 897,379 bottles made for Vintage Pharmaceuticals, doing business as Qualitest.

Uncovering data for any given hydrocodone acetaminophen recall can be a tough task, especially since the FDA displays its information in a somewhat convoluted manner. In the list below, we serve up a simple summary of all recalls of this common generic, including dates, number of affected bottles, manufacturer names, reasons for each recall, and lot numbers.

Hydrocodone Acetaminophen Recalls

There have been 11 Hydrocodone Acetaminophen recalls from 2012 through 2017. They were issued either voluntarily by the manufacturer or else mandated by the FDA.

The affected businesses were Qualitest, Mallinckrodt, VistaPharm, Watson Laboratories, Mylan Institutional, and Aidapak Services.

A few of the recalls were small in scope. For example, in one case, Aidapak Services made a labeling error on a run of 100 tablets. However, the Vintage Pharmaceuticals/Qualitest recall of late 2012 involved nearly 900,000 bottles in a Class I event, the most urgent and life-threatening FDA recall possible.

See the complete list of all Hydrocodone Acetaminophen recalls from through 2017 below.

Hydrocodone Acetaminophen Facts

Via: NIH.gov

Hydrocodone acetaminophen is a mix of narcotic and non-narcotic pain relievers. Acetaminophen is added to increase the pain-relief effects from hydrocodone. It goes by many brand names, including Vicodin, Lortab, Zydone, Liquicet, and Polygesic.

Serious side effects of hydrocodone acetaminophen include slow heartbeat, shallow breathing, seizures, stomach pain, fainting, confusion, and jaundice. It can conflict with several different drugs and medical conditions, so thorough research is encouraged before prescribing.

Major Hydrocodone Acetaminophen Recalls

There were five major recalls of hydrocodone acetaminophen from 2012 through 2017. Each one affected more than 4,000 bottles of the popular generic drug. They stemmed from six manufacturers and/or suppliers, including Vintage Pharmaceuticals (or Qualitest), Mallinckrodt, VistaPharm, Watson Laboratories, Mylan Institutional, and Aidapak Services.

Some of these recalls were quite large and urgent, with one affecting nearly 900,000 bottles and another spanning two separate recall orders.

Below, we show the biggest six recalls by year and by company. For details on all 11 hydrocodone acetaminophen recalls to date, see the sections further down in this article.

  • 2017 Hydrocodone Acetaminophen recall: Approx. 32,000 bottles, VistaPharm.
  • 2012 Hydrocodone Acetaminophen recall: Approx. 14,000 bottles, Qualitest/Vintage Pharmaceuticals.
  • 2012 Hydrocodone Acetaminophen recall: Approx. 5,000 bottles, Watson Laboratories.
  • 2012 Hydrocodone Acetaminophen recall: Approx. 900,000 bottles, Qualitest/Vintage Pharmaceuticals.
  • 2012 Hydrocodone Acetaminophen recall: Approx. 85,000 bottles, Mallinckrodt.
Via: NIH.gov

Hydrocodone Acetaminophen Manufacturers

Dozens of companies make Lisinopril. There’s a partial list below.

  • Mallinckrodt
  • Caraco
  • Marin Pharm
  • Pharmaceutical Associates
  • Forest Pharmaceuticals
  • Tris Pharma
  • Rhodes Pharmaceuticals
  • Amneal Pharmaceuticals
  • Mayne Pharma
  • Mikart

Full List of All Hydrocodone Acetaminophen Recalls

Here’s the full list of all 11 official FDA hydrocodone acetaminophen recalls as of 6/12/17. Two of the recalls are effectively the same event, issued on the same date, but separated into two separate orders by severity and affecting over 40,000 bottles each.

Several of the recalls are relatively small and aren’t included in our master list of major events, above.

What’s the Difference Between the FDA’s Class I, II, and III Recalls?

Hydrocodone acetaminophen recalls are defined by their FDA class numbers. We’ve included a short description of each class below for your reference.

Class I Recall. Urgent, with serious danger of immediate death or severe injury. This is a rare recall type. Four of the 11 H.A. recalls so far are Class I.

Class II Recall. Serious, with danger of death or severe injury, but not as immediate as Class I. Five of the H.A. recalls fall into this category.

Class III Recall. This is the least serious of the recall types, with no immediate danger. They generally arise from superficial violations of FDA regulations. Two of the hydrocodone acetaminophen recalls to date are Class III.

About the List Below

When the FDA creates a recall (whether or not it originated voluntarily from the manufacturer), the event is shown below as the issue date. The FDA later classifies each recall as Class I, II, or III on the classification date. If the recall is then terminated, it’s assigned a termination date. We’ve listed all hydrocodone acetaminophen recalls below by the date they were classified. The first bullet point for each entry is then the issue date.

Via: NIH.gov

2/2/2017 Hydrocodone Acetaminophen Recall, Class II

  • Recall issued 1/18/2017.
  • 325 mg per 15ml Hydrocodone Acetaminophen Oral Solution, 120 ml bottle, 473 ml bottle and 15 ml unit dose cups.
  • Manufacturer: VistaPharm, Inc.
  • Reason: CGMP Deviations, possibly contaminated with Burkholderia cepacia.
  • 32,027 bottles and 16,310 unit dose cups.
  • Lot # 419000, 419800, 429100, 418200, 430100, 423800, 413100, 410700

1/30/2014 Hydrocodone Acetaminophen Recall, Class II

  • Recall issued 1/15/2014.
  • 660 mg Hydrocodone Acetaminophen Tablets, 100-count bottles.
  • Manufacturer: Watson Laboratories, Inc.
  • Reason: Contains broken tablets.
  • 717 bottles.
  • Lot # 697316A.

1/16/2014 Hydrocodone Acetaminophen Recall, Class II

  • Recall issued 7/2/2013.
  • 325 mg Hydrocodone Acetaminophen Tablets.
  • Manufacturer: AidaPak Service, LLC.
  • Reason: Label Mixup, possibly mislabelled as Melatonin Tablets.
  • 100 tablets.
  • Pedigree: W004005.

9/17/2013 Hydrocodone Acetaminophen Recall, Class III

  • Recall issued 8/30/2013.
  • 650 mg Hydrocodone Acetaminophen Tablets, 500-count bottle.
  • Manufacturer: Watson Laboratories, Inc.
  • Reason: Bottles might not have tamper-evident seals correctly seated.
  • 875 bottles.
  • Lot # 706224A, 706225A.

11/16/2012 Hydrocodone Acetaminophen Recall, Class I

  • Recall issued 9/10/2012.
  • 500 mg Hydrocodone Acetaminophen Tablets, 100-count bottle.
  • Manufactured for Qualitest Pharmaceuticals.
  • Reason: Superpotent Drug.
  • 14,445 bottles.
  • Lot # C1440512A.
Via: NIH.gov

11/16/2012 Hydrocodone Acetaminophen Recall, Class I

  • Recall issued 9/21/2012.
  • 500 mg Hydrocodone Acetaminophen Tablets, 500-count bottle.
  • Manufacturer: Watson Laboratories, Inc.
  • Reason: Superpotent Drug.
  • 4,874 bottles.
  • Lot # 519406A, 521759A.

1/30/2013 Hydrocodone Acetaminophen Recall, Class I

  • Recall issued 12/6/2012.
  • 500 mg Hydrocodone Acetaminophen Tablets, 30-count bottle, 60-count bottle, 90-count bottle, 100-count bottle, 120-count bottle, 150-count bottle, 180 count bottle, 500-count bottle and 1000-count bottle.
  • Manufactured for Qualitest Pharmaceuticals.
  • Reason: Superpotent Drug.
  • 897,379 bottles.
  • Lot #: All that begin with the letter “C” – C1160712C, C0930812A, C1110412A, C1141012B, C1160712A, C0950812B, C1110412B, C1151012B, C1160712B, C1530512A, C0540212A, C0550212A, C0560212A, C0710312A, C0720312A, C0730112B, C0730312A, C0740112B, C0740312A, C0750112A, C0760112A, C0770112C, C0780112C, C0790112C, C0860812A, C0870812A, C0880812A, C0890812A, C0900812A, C0910812A, C0920812A, C0950412A, C0950812D, C0960412A, C0970412A, C0980412A, C1030412A, C1040412A, C1050412A, C1060412A, C1061012A, C1070412A, C1071012A, C1081012A, C1101012A, C1111012A, C1120412A, C1121012A, C1130412A, C1131012A, C1140412A, C1141012A, C1160712D, C1440512A, C1450512A, C1460512A, C1470512A, C1510512A, C1520512A, C1530512B, C1540512A, C1550512A, C1560512A, C1570512A, C0670312A, C0680312A, C0930812B, C0950812C, C1160712E, C0950812A, C1110412C, C0630212B, C0640212B, C0690312A, C0700312A, C0720112B,C0940812A, C0941112A, C0960812A, C1010412B, C1020412B, C1080412A, C1090412A, C1100412A, C1170712A, C1180712A, C1480512A, C1490512A, C1500512A, C0570212B, C0580212B, C0590212B, C0600212A, C0610212A, C0620212A, C0750312A, C0760312A, C0930812C, C0970812A, C0990412A, C1000412A.

2/15/2013 Hydrocodone Acetaminophen Recall, Class I

  • Recall issued 12/14/2012.
  • 500 mg Hydrocodone Acetaminophen Tablets, 100 tablet carton.
  • Manufactured for Qualitest Pharmaceuticals.
  • Reason: Superpotent Drug.
  • 3,407 cartons. (Each carton contained 20 blister tablets).
  • Lot # 3037841, 3040859, 3042573

7/31/2012 Hydrocodone Acetaminophen Recall, Class II

  • Recall issued 5/25/2012.
  • 500 mg per 15mL Hydrocodone Acetaminophen Oral Solution, 473mL bottle.
  • Manufacturer: Mallinckrodt Inc.
  • Reason: CGMP Deviations – expired flavoring used.
  • 44,330 bottles.
  • Lot # 0375P76192, 0375T80512, 0375T81209.

7/12/2012 Hydrocodone Acetaminophen Recall, Class II

  • Recall issued 5/30/2012.
  • 325 mg per 15mL Hydrocodone Acetaminophen Oral Solution, 50-unit dose cups per case, 473 mL bottle.
  • Manufacturer: VistaPharm Inc.
  • Reason: Impurities/degradation.
  • 949 cases and 188 bottles. (Cases contained 50 dose cups each)
  • Lot # 251400, 251500.

7/31/2012 Hydrocodone Acetaminophen Recall, Class III

  • Recall Issued 5/25/2012.
  • 500 mg per 15 mL Hydrocodone Acetaminophen Oral Solution, 473 mL bottle.
  • Manufacturer: Mallinckrodt Inc.
  • Reason: Subpotent Drug.
  • 41,100 bottles.
  • Lot # 0375T79384, 0375T81348, 0375U82277.

Conclusion

The list above gives an easy reference for the five major (and six other) hydrocodone acetaminophen recalls as of 6/12/17. The biggest of the 11 total recalls was the 2012 Class I recall against Vintage Pharmaceuticals AKA Qualitest, involving 897,379 bottles. That recall originated from a superpotent drug issue.

A second large-scale recall affected over 85,000 bottles of the drug, and stemmed from the use of expired inactive ingredients and a lower-than-spec dosage of the active ingredient.

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Disclosure: The images in this article are for illustrative purposes only and don’t necessarily reflect recalled examples.

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