Posted on June 26, 2017

There have been six major Azithromycin recall events from 2012 through 2017, as of 6/26/17. The biggest involved about 400,000 bottles of the popular antibiotic from Wockhardt USA.

It’s somewhat daunting to find cleanly presented data on all Azithromycin recalls to date, due to somewhat convoluted FDA data presentation. Below, we’ve simplified all Azithromycin recall facts, with manufacturer names, dates, numbers of bottles or cartons, reasons for the recalls, and lot numbers.

Azithromycin Recalls

There have been 11 total recalls of Azithromycin from 2012-2017. The recall orders were either mandated by the FDA or voluntarily initiated by the manufacturers.

The businesses involved are PD-Rx Pharmaceuticals, Wockhardt USA, Attix Pharmaceuticals, Health Innovations Pharmacy, American Health Packaging, and Pfizer.

The smallest Azithromycin recall was a 5,000-carton event from American Health Packaging. That recall occurred because of a failure by the business to thoroughly investigate complaints made by customers.

The full list of all Azithromycin recalls from 2012 through 2017 is below.

Azithromycin Facts

Via: Wikimedia Commons

Azithromycin is a popular generic antibiotic that goes by the brand names Zithromax and Zmax. It’s used in the treatment of various bacterial infections, including skin infections, respiratory infections, STDs, and ear infections.

Serious side effects can include severe allergic reactions that present as hives, swelling, and/or difficulty breathing, or in rare cases, severe and even fatal skin reactions. More common side effects are nausea, headache, and diarrhea.

Major Azithromycin Recalls

The five major Azithromycin recalls from 2012 through 2017 each involved over 5,000 cartons, bottles, vials, or grams of the medication. Most are made up of multiple distinct FDA recall orders.

Below is the top-line view of all Azithromycin recalls so far. For a more involved view, scroll down.

  • 2016 Azithromycin recall: Approx. 62,000 bottles, PD_Rx Pharmaceuticals.
  • 2015 Azithromycin recall: Approx. 30 kilos, Attix Pharmaceuticals.
  • 2015 Azithromycin recall: All lots, Health Innovations Pharmacy.
  • 2015 Azithromycin recall: Approx. 400,000 bottles, Wockhardt USA.
  • 2015 Azithromycin recall: Approx. 5,000 cartons, American Health Packaging
  • 2014 Azithromycin recall: Approx. 101,000 bottles, Pfizer.

Azithromycin Manufacturers

Azithromycin is one of the World Health Organization’s essential medicines. Since it’s been a heavily prescribed antibiotic for decades, dozens of manufacturers make it. There’s a partial list of Azithromycin makers below.

  • BOC Sciences
  • Wockhardt
  • Sun Pharmaceuticals
  • Triochem Products
  • Pfizer
  • Attix Pharmaceuticals
  • PD-Rx Pharmaceuticals
  • Sandoz
  • Betterway Pharmaceutical Group
  • Alembic

Full List of All Azithromycin Recalls

Here’s the full list of all 11 FDA Azithromycin recall orders since 2012. It includes many FDA recall orders for the major recalls listed above.

Class I, II, and III Recalls

Azithromycin recalls are grouped into either Class II or Class III FDA categories. The classifications are defined as follows:

Class I Recall. Urgent risk of death/injury. None of the Azithromycin recalls in this article are Class I.

Class II Recall. Non-immediate risk of death/injury. 10 of the 11 recalls below are Class II.

Class III Recall. This recall type is for non life-threatening FDA violations. One of the 11 Azithromycin recalls below is Class III.

About the Recall Dates Below

We’ve listed each Azithromycin recall below in reverse order for the date it was classified. The issue date for each recall is shown in the first bullet point.

Via: Wikimedia Commons

1/5/2016 Azithromycin Recall, Class II

  • Recall issued 4/29/2015.
  • 250 mg Azithromycin Tablets, 2-count bottle and 4-count bottle.
  • Manufactured for PD-RX Pharmaceuticals, Inc.
  • Reason: CGMP Deviations – inadequate investigation of customer concerns by firm.
  • 45,022 bottles.
  • Lot # J12A48, L12A23, A13G04, A13H14, B13E97, C13B55, J13F75, L13C93, A14F78, A14H17, B14A6, I13D47, I13G28, J13D73, J13D93, K13E18, A14H06, C14A49, C14D01, A14B95.

1/5/2016 Azithromycin Recall, Class II

  • Recall issued 4/29/2015.
  • 500 mg Azithromycin Tablets, 1-count bottle, 2-count bottle, 3-count bottle and 7-count bottle.
  • Manufactured for PD-RX Pharmaceuticals, Inc.
  • Reason: CGMP Deviations – inadequate investigation of customer concerns by firm.
  • 17,533 bottles.
  • Lot # J12C03, J12D19, L12B52, L12E79, L12G92, A13G14, A13H49, B13G53, D13A66, E13E35, F13A58, F13D85, F13F17, F13F27, G13D37, G13E57, H13A65, H13A74, H13C13, H13G01, I13C02, I13G98, J13C53, J13G90, K13A65, K13B73, K13C98, K13E61, L13C59, L13F49, A14C27, A14D09, A14F11.

4/20/2015 Azithromycin Recall, Class II

  • Recall issued 11/14/2014.
  • Azithromycin Dihydrate packaged in bags or drums.
  • Manufacturer: Attix Pharmaceuticals.
  • Reason: Penicillin Cross Contamination.
  • 30,316 grams.
  • All lots repackaged and distributed between 01/05/12 to 02/12/15.

5/8/2015 Azithromycin Recall, Class II

  • Recall issued 2/12/2015.
  • 100 mg Azithromycin rectal suppository.
  • Manufactured for Health Innovations Pharmacy, Inc.
  • Reason: Lack of Assurance of Sterility and Stability.
  • All lots.

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7/17/2015 Azithromycin Recall, Class II

  • Recall issued 4/22/2015.
  • 250 mg Azithromycin Tablets, 30-count bottle, 3,500-count pouches and 3×6 cartons.
  • Manufactured for Wockhardt Usa Inc.
  • Reason: CGMP Deviations – no adequate investigation of customer complaints.
  • 280,520 bottles, 571 pouches and 1,629,253 cartons.
  • Lot numbers: Too many to list. See full recall report here.

7/17/2015 Azithromycin Recall, Class II

  • Recall issued 4/22/2015.
  • 500 mg Azithromycin Tablets, 30-count bottle and 3×3 cartons.
  • Manufactured for Wockhardt Usa Inc.
  • Reason: CGMP Deviations – no adequate investigation of customer complaints.
  • 112,120 bottles, 178,580 cartons.
  • Lot numbers: Too many to list. See full recall report here.

7/17/2015 Azithromycin Recall, Class II

  • Recall issued 4/22/2015.
  • 600 mg Azithromycin Tablets, 30-count bottle.
  • Manufactured for Wockhardt Usa Inc.
  • Reason: CGMP Deviations – no adequate investigation of customer complaints.
  • 7,584 bottles.
  • Lot # LN10991, LN11381.

7/8/2015 Azithromycin Recall, Class II

  • Recall issued 6/1/2015.
  • 500 mg Azithromycin tablets, 10×3 cartons.
  • Manufactured for Wockhardt, USA, LLC.
  • Reason: CGMP Deviations – no adequate investigation of customer complaints.
  • 2,558 cartons.
  • Lot # 134419A, 193441B, 133684B.

7/8/2015 Azithromycin Recall, Class II

  • Recall issued 6/1/2015.
  • 600 mg Azithromycin tablets, 10×3 cartons.
  • Manufactured for Wockhardt, USA, LLC.
  • Reason: CGMP Deviations – no adequate investigation of customer complaints.
  • 838 cartons.
  • Lot # 134420, 142540.

7/8/2015 Azithromycin Recall, Class II

  • Recall issued 6/1/2015.
  • 250 mg Azithromycin tablets, 10×10 cartons.
  • Manufactured for Wockhardt, USA, LLC.
  • Reason: CGMP Deviations – no adequate investigation of customer complaints.
  • 2,068 cartons.
  • Lot # 134392.

1/16/2014 Azithromycin Recall, Class III

  • Recall issued 1/2//2014.
  • 500 mg Azithromycin per vial.
  • Manufactured by Pfizer Inc.
  • Reason: Failed Impurities/Degradation Specifications.
  • 101,681 Vials.
  • Lot # G81845, 0B0CJ, G44710, G65241, G80003, G82722, G93028, G95309, G97641.

Conclusion

This list makes it easy to find any of the six major Azithromycin recalls as of 6/26/17, encompassing 11 total FDA recall orders. The biggest recall in 2015 came from Wockhardt Pharmaceuticals and affected over 400,000 bottles of the popular antibiotic. The next biggest was a Pfizer recall in 2014 that hit over 101,000 vials.

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