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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Brinzolamide Ophthalmic Suspension Recalled for Dropper Blockage Risk

Agency Publication Date: January 14, 2022
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Summary

Teva Pharmaceuticals USA is voluntarily recalling approximately 87,342 bottles of Brinzolamide Ophthalmic Suspension, USP 1% (a generic eye medication) due to a defect in the dropper container. A piece of the cap notch can break off and block the nozzle, which may prevent the medicine from being dispensed correctly. The recall affects 10 ml and 15 ml dropper bottles with various lot numbers and expiration dates ranging from November 2022 to March 2023.

Risk

If the dropper nozzle is blocked, patients may be unable to dispense their medication, leading to missed doses and potential health complications like increased eye pressure. No injuries or incidents have been reported to date.

What You Should Do

  1. This recall affects Teva Brinzolamide Ophthalmic Suspension, USP 1% packaged in 10 ml dropper bottles (NDC 0591-2127-79) and 15 ml dropper bottles (NDC 0591-2127-12). See the Affected Products section below for the full list of affected codes.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Teva Pharmaceuticals USA for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Brinzolamide Ophthalmic Suspension, USP 1% (10 ml)
Variants: 10 ml dropper bottle
Lot Numbers:
BCB1LB2 (Exp. 11/2022)
BCB2LB2 (Exp. 11/2022)
BCB7LB2 (Exp. 11/2022)
BCB11AC2 (Exp. 12/2022)
BCB12AC2 (Exp. 12/2022)
BCB3AC2 (Exp. 12/2022)
BCB4AC2 (Exp. 12/2022)
BCB5AC2 (Exp. 12/2022)
BCB6AC2 (Exp. 12/2022)
BCB10AC2 (Exp. 12/2022)
NDC:
0591-2127-79

Rx Only

Product: Brinzolamide Ophthalmic Suspension, USP 1% (15 ml)
Variants: 15 ml dropper bottle
Lot Numbers:
BCB4LB2 (Exp. 11/2022)
BCB5LB2 (Exp. 11/2022)
BCB1AC2 (Exp. 12/2022)
BCB2AC2 (Exp. 12/2022)
BCB1DC2 (Exp. 03/2023)
BCB2DC2 (Exp. 03/2023)
NDC:
0591-2127-12

Rx Only

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89192
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: a) 66,099 dropper bottles; b) 21,243 dropper bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.