Altaire Ciprofloxacin Ophthalmic Solution Recalled for Sterility Concerns
Altaire Pharmaceuticals is recalling Ciprofloxacin HCL Ophthalmic Solution due to a lack of assurance of sterility. The recall affects 3,060 units distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for serious injury or hospitalization (implied by sterility failure in an ophthalmic product) fall under the Severe category.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling 3,060 units of Ciprofloxacin HCL Ophthalmic Solution, USP, 0.3%, 2.5 mL. The product is a prescription ophthalmic solution manufactured by Altaire Pharmaceuticals, Inc. in Aquebogue, NY.
The recall was initiated due to a lack of assurance of sterility. The affected product has the code 18164 7/20 and NDC 59390-217-02. The recall is classified as FDA Class II.
The product was distributed nationwide in the U.S.A. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- CIPROFLOXACIN HCL OPHTHALMIC (CIPROFLOXACIN HYDROCHLORIDE)
- Brand
- CIPROFLOXACIN HCL OPHTHALMIC
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 3,060
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 18164 7/20
UPCs (1)
- 4776638217054
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 134 recalled by Altaire Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 134 products in this recall →Related recalls
Same brand · CIPROFLOXACIN HCL OPHTHALMIC
- SevereAltaire Ciprofloxacin Ophthalmic Solution Recalled for Sterility Assurance Issues
FDA (Drugs) · 2019-11-27
- SevereAltaire Recalls Ciprofloxacin Ophthalmic Solution Due to Sterility Concerns
FDA (Drugs) · 2019-11-27
Same manufacturer · Altaire Pharmaceuticals, Inc.
See all →- SevereCVS Health Dry Eye Relief Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2019-11-27
- SevereCVS Health Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2019-11-27
- SevereCVS Health Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2019-11-27
- SevereAltaire Recalls Equate Support Advanced Twin Pack Due to Sterility Concerns
FDA (Drugs) · 2019-11-27
- SevereAltaire Recalls OCuSOFT Ophthalmic Ointment Due to Sterility Concerns
FDA (Drugs) · 2019-11-27
Same hazard · lack of sterility
See all →- HighRohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighRohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-07-29
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15