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Lower risk Drug recall · FDA · Published December 8, 2021

Teva Brinzolamide Ophthalmic Suspension 1% Recall: Cap Notch May Block Dropper

Teva Pharmaceuticals recalls Brinzolamide Ophthalmic Suspension 1% dropper bottles due to a cap notch that may break off and block the dropper, preventing product dispensing.

🇺🇸 FDA recall #D-0373-2022DrugTeva Pharmaceuticals ›
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Recalling firmTeva Pharmaceuticals USA400 Interpace Pkwy · Parsippany, NJ 07054-1120
✎ GovInfoNow plain-language explainer

Teva Pharmaceuticals is recalling Brinzolamide Ophthalmic Suspension 1% dropper bottles because the cap's notch could break off and block the dropper, potentially preventing the medication from dispensing. This could lead to incomplete treatment if the medication isn't properly administered. Read more at govinfonow.com/recall/35424-teva-brinzolamide-ophthalmic-suspension-1-recall-cap-notch-may-block.

Source Summary by GovInfoNow · govinfonow.com/recall/35424-teva-brinzolamide-ophthalmic-suspension-1-recall-cap-notch-may-block · Updated August 18, 2026 · FDA enforcement record: FDA #D-0373-2022

Cite this page

“Teva Brinzolamide Ophthalmic Suspension 1% Recall: Cap Notch May Block Dropper.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35424-teva-brinzolamide-ophthalmic-suspension-1-recall-cap-notch-may-block. Based on FDA recall #D-0373-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0373-2022%22&limit=1).

The FDA announced on Dec. 8, 2021, that Teva Pharmaceuticals USA is recalling Brinzolamide Ophthalmic Suspension, USP 1%, due to defective containers that may block the dropper. The recall affects specific lots of 10 ml and 15 ml bottles distributed nationwide.

How to tell if you have it

  • Brand: Teva Pharmaceuticals
  • Product: Brinzolamide Ophthalmic Suspension, USP 1%
  • NDC 0591-2127-79 (10 ml dropper bottles)
  • NDC 0591-2127-12 (15 ml dropper bottles)
  • Lots: BCB1LB2, BCB2LB2, BCB7LB2 (Exp. 11/2022)
  • Lots: BCB11AC2, BCB12AC2, BCB3AC2, BCB4AC2, BCB5AC2, BCB6AC2, BCB10AC2 (Exp. 12/2022)
  • Lots: BCB4LB2, BCB5LB2 (Exp. 11/2022)
  • Lots: BCB1AC2, BCB2AC2 (Exp. 12/2022)
  • Lots: BCB1DC2, BCB2DC2 (Exp. 03/2023)

The hazard

According to the FDA, the notch in the cap that fits into the nozzle of the dropper could break off and block the dropper, possibly resulting in the product not dispensing.

Context

GovInfoNow's records show Teva Pharmaceuticals USA has 97 other recalls on record since Oct. 11, 2013. Other recent recalls of similar products include Teva Doxylamine Succinate Tablets Recall (Jan. 18, 2022), Teva Tretinoin Capsules 10mg Recall (Jan. 10, 2022), and Teva Mimvey Tablets Recall (Jan. 7, 2022). Other recent recalls of similar products include Micro Labs Dorzolamide/Timolol Eye Drops Recall (July 22, 2026) and Teva Clonidine Transdermal System Recall (March 19, 2026).

How to tell if you have this one

Check for Brinzolamide Ophthalmic Suspension 1% dropper bottles with NDC 0591-2127-79 (10 ml) or NDC 0591-2127-12 (15 ml). The product was manufactured in India by Indoco Remedies Limited and distributed by Teva Pharmaceuticals USA.

  • Brand
    Teva Pharmaceuticals
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for NDC codes 0591-2127-79 (10 ml) or 0591-2127-12 (15 ml) on the bottle.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 18 months after the firm started it.

1. Firm started the recall: Dec 8, 202112. FDA classified it Class II: Jan 14, 202223. Published in FDA’s Enforcement Report: Jan 26, 202234. FDA terminated the recall: Jun 1, 2023420212023
  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.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall is for potential blockage of the dropper, but the product is generally safe if the cap notch does not break off.

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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-0373-2022 (December 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0373-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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