Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
0 Class I (most serious) drug recalls reported in the last 30 days.
8 recalls
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Class II Ongoing
BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 – Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India – 380014, Email:info@omnilens.in, Manufac…
Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lots, distribution and details
- Product
- BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 – Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India – 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11.
- Lots / codes
- All lots
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 184,320 containers
- Recall started
- December 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0352-2026
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Class II Ongoing
Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 – Samruddhi, Opp. Sakar – III, Navrangpura, Ahmedabad – 380014, India, Email:info@omnilens.in, Manufactured for &…
Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lots, distribution and details
- Product
- Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 – Samruddhi, Opp. Sakar – III, Navrangpura, Ahmedabad – 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.
- Lots / codes
- All lots
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 50,400 Boxes
- Recall started
- December 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0351-2026
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Class II Ongoing
CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bh…
Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Lots, distribution and details
- Product
- CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,
- Lots / codes
- All lots
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 10,080 boxes
- Recall started
- December 31, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0350-2026
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Class III Ongoing
Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496
Reason: Subpotent Drug
Lots, distribution and details
- Lots / codes
- 06092025@23 BUD 09/09/2025
- Distribution
- U.S. Nationwide
- Quantity
- 8 vials
- Recall started
- July 9, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0607-2025
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Class II Ongoing
FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-404-01.
Reason: Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Lots, distribution and details
- Lots / codes
- Lot #: 14776, Exp. 05/31/2024.
- Distribution
- Nationwide in the USA
- Quantity
- 15,444 cartons
- Recall started
- April 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0465-2024
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Class II Ongoing
FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-403-03.
Reason: Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Lots, distribution and details
- Lots / codes
- Lot 14842, Exp. 6/30/2024
- Distribution
- Nationwide in the USA
- Quantity
- 4648 cartons
- Recall started
- April 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0464-2024
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Class II Ongoing
GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx Only, 100 Sterile Strips per carton, Nomax, Inc., St. Louis, MO 63123, NDC 51801-009-40.
Reason: Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Lots, distribution and details
- Lots / codes
- Lot #: 14708, Exp. 04/30/2024.
- Distribution
- Nationwide in the USA
- Quantity
- 6,960 cartons
- Recall started
- April 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0463-2024
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Class II Ongoing
GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC 51801-003-40; b) 300 strips per carton, NDC 51801-003-50, Nomax, Inc., St. Louis, MO 63123.
Reason: Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Lots, distribution and details
- Lots / codes
- Lot #s: a) 14904, Exp. 06/30/2024; Lot 14938, Exp. 07/31/2024; b) Lot 14931, Exp. 06/30/2024
- Distribution
- Nationwide in the USA
- Quantity
- 15,056 cartons
- Recall started
- April 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0462-2024
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.