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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 6,841–6,860 of 17,964 drug recalls

Drug Recall Completed Historical recordClass II

Altaire Homatropaire Homatropine Hyrdobromide Opthalmic Solution, USP, 5 %, 5 mL, Sterile, Rx only, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-192-05

by Altaire Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
July 2, 2019
Reported by FDA
November 27, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Completed Historical recordClass II

CVS Health Extra Strength Lubricant Gel Drops Twin Pack, Item#: 258587, Product Size: 2 x 15 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

by Altaire Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
July 2, 2019
Reported by FDA
November 27, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Completed Historical recordClass II

OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Ophthalmic Ointment, 0.5 fl oz. (15mL), Distributed by OCuSOFT, Inc. Rosenberg, TX 77471 USA

by Altaire Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
July 2, 2019
Reported by FDA
November 27, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Completed Historical recordClass II

OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Opthalmic Ointment, Net. wt. 1/8 oz (3.5 g), Sterile, Distributed by OCuSOFT, Inc. Rosenberg, TX 77471 USA

by Altaire Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
July 2, 2019
Reported by FDA
November 27, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Completed Historical recordClass II

OCuSOFT Tears Again Sterile Lubricant Eye Drops, Net Wt 30mL (1 fl oz), Manufactured for OCuSOFT Inc., Rosenberg, TX 77471 USA, NDC 54799-904-30

by Altaire Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
July 2, 2019
Reported by FDA
November 27, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Completed Historical recordClass II

OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactured for OCuSOFT Inc. Rosenberg, TX 77471 USA, NDC 54799-904-15

by Altaire Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
July 2, 2019
Reported by FDA
November 27, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Completed Historical recordClass II

OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution, USP (Sterile) 5 mL Rx only, Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-507-21

by Altaire Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
July 2, 2019
Reported by FDA
November 27, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Completed Historical recordClass II

OCuSOFT Eye Wash Sterile Isotonic, 4 FL OZ (118 mL), Manufactured for OCuSOFT, INC Richmond, TX 7406-0429 Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 Made in USA, NDC 54799-565-59

by Altaire Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
July 2, 2019
Reported by FDA
November 27, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Completed Historical recordClass II

OCuSOFT Eye Wash Sterile Isotonic Buffered Solution, 1 FL OZ (30 mL), Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-565-01

by Altaire Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
July 2, 2019
Reported by FDA
November 27, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Completed Historical recordClass II

OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic, 5 mL, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 Made in USA, NDC 54799-505-05

by Altaire Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
July 2, 2019
Reported by FDA
November 27, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Completed Historical recordClass II

OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 mL, Mfd. For OCuSOFT, Inc. Rosenberg, TX 77471 Mfg. By: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 54799-504-05

by Altaire Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
July 2, 2019
Reported by FDA
November 27, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Completed Historical recordClass II

OCuSOFT Tetravisc Forte (Tetracaine HCl) 0.5% Sterile Anesthetic, 0.6 mL Single Dose (12/CT), Rx only, OCuSOFT, Inc. PO Box 492 Richmond TX 77406-0429 800-233-5469 Made in USA, Mfg. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 54799-504-01

by Altaire Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
July 2, 2019
Reported by FDA
November 27, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Completed Historical recordClass II

OCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution, Net Wt. 0.5 fl oz (15 mL), Mfd. for: OCuSOFT Inc. PO Box 429 Richmond, TX 77406-0429, NDC 54799-503-15

by Altaire Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
July 2, 2019
Reported by FDA
November 27, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Completed Historical recordClass II

Tetcaine (Tetracaine Hydrochloride) Ophthalmic Solution USP, 0. 5 fl oz (15 mL), Rx only, Manufactured for OCuSOFT, Inc. Rosenberg, TX 77471 USA, NDC 54799-502-15

by Altaire Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
July 2, 2019
Reported by FDA
November 27, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Completed Historical recordClass II

OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenberg, TX 77471, Mfd. by Altaire Pharmaceuticals, Inc, Aquebogue, NY 11931 NDC 54799-431-05

by Altaire Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
July 2, 2019
Reported by FDA
November 27, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Completed Historical recordClass II

ActivEyes Lubricant Eye Ointment Preservative Free, Product Size: 3.5 gram, Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931,NDC 59390-189-50

by Altaire Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
July 2, 2019
Reported by FDA
November 27, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Completed Historical recordClass II

ActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF Sterile, 0.25 FL OZ (7.5 mL), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-146-52

by Altaire Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
July 2, 2019
Reported by FDA
November 27, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Completed Historical recordClass II

ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops Long Lasting PF Sterile, 0.25 FL OZ (7.5 mL), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-148-52

by Altaire Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
July 2, 2019
Reported by FDA
November 27, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Completed Historical recordClass II

Ofloxacin Ophthalmic Solution, USP, 0.3%, 5 mL, Rx only, Altaire Pharmaceuticals, Inc., NDC 59390-140-05

by Altaire Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
July 2, 2019
Reported by FDA
November 27, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Completed Historical recordClass II

iSolutions Nano Tears XP Clear Emollient Lubricant Gel Drops Moderate Sterile, 1/3 FL OZ (10 mL), Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-143-10

by Altaire Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
July 2, 2019
Reported by FDA
November 27, 2019
Distribution
U.S.A. Nationwide

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.