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Unrated Drug recall · FDA · Published March 19, 2019

Allergan Recalls Combigan Eye Drops Due to cGMP Deviations

Allergan Sales, LLC is recalling specific lots of Combigan ophthalmic solution due to current Good Manufacturing Practice deviations. Check your bottle's lot number.

🇺🇸 FDA recall #D-1056-2019DrugAllergan ›
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Recalling firmAllergan Sales, LLC8301 Mars Dr · Waco, TX 76712-6578
✎ GovInfoNow plain-language explainer

What happened, in plain English

Allergan Sales, LLC has recalled Combigan (brimonidine tartrate/timolol maleate) ophthalmic solution in 5 mL bottles due to deviations from current Good Manufacturing Practices (cGMP). The recall affects only 72 bottles distributed exclusively in Tennessee. The record does not specify the exact nature of the cGMP deviation or any associated health risks. Read more at govinfonow.com/recall/39078-allergan-recalls-combigan-eye-drops-due-to-cgmp-deviations.

Source Summary by GovInfoNow · govinfonow.com/recall/39078-allergan-recalls-combigan-eye-drops-due-to-cgmp-deviations · Updated October 11, 2026 · FDA enforcement record: FDA #D-1056-2019

Cite this page

“Allergan Recalls Combigan Eye Drops Due to cGMP Deviations.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/39078-allergan-recalls-combigan-eye-drops-due-to-cgmp-deviations. Based on FDA recall #D-1056-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1056-2019%22&limit=1).

Why it’s dangerous

The hazard is classified as cGMP deviations, which means manufacturing processes did not meet federal quality standards. The record does not describe what these deviations were or how they might impact the safety or efficacy of the medication.

Who’s affected

Patients in Tennessee who were prescribed Combigan eye drops and possess bottles with the specific lot number and expiration date listed below are affected by this recall.

How to tell if you have this one

Check your eye drop bottle for the following details: Product name Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, NDC 0023-9211-05, Lot# 99946, and Expiration date January 16, 2021.

  • Brand
    Allergan
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Your Bottle

    Verify if your Combigan bottle matches the recalled lot number (99946) and expiration date (January 16, 2021).

  2. Contact Your Pharmacist

    If you have the recalled product, contact your pharmacist or healthcare provider for instructions on what to do next.

Where it went and when

Where it was distributed

Distributed in Tennessee.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: yesTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “TN only” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Tennessee.

Recall timeline

FDA terminated this recall 13 months after the firm started it.

1. Firm started the recall: Mar 19, 201912. FDA classified it Class II: Mar 22, 201923. Published in FDA’s Enforcement Report: Apr 3, 201934. FDA terminated the recall: Apr 29, 2020420192020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-1056-2019 (March 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1056-2019 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA