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Recall totals

All FDA and USDA recalls in Public Health Trace, June 2012 to September 2026.

37,115

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,793

Class I recallsReasonable probability of serious health consequences

24,343

Class II recallsTemporary or medically reversible health consequences

2,887

Class III recallsNot likely to cause adverse health consequences

Quick insights

A snapshot of the most notable patterns across all recorded FDA and USDA recalls.

Most recalled product100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap. 53 recalls

Most common hazardLack of Assurance of Sterility 2,072 recalls

Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/so-delicious-dairy-freer-issues-voluntary-recall-salted-caramel-cluster-non-dairy-frozen-dessertPublished September 15, 2026

Most affected stateHawaii 200 recalls mention this state

State: AS ×
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Recalls announced by month (Year to date)

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Source: FDA and USDA public dataLast updated September 16, 2026 ET

Summary (Year to date)

1,527 recalls have been announced year to date.
Aug 2026 was 24% lower than the previous complete period (Jul 2026: 240).
The highest complete period was Jun 2026 (297).
Sep 2026 is incomplete and not included in the figures above.

Complete data
Incomplete

Recalls by class

Recalls by class
Class	Recalls
Class II	24,343
Class I	9,793
Class III	2,887
Not Yet Classified	1

Recalls by class
Class	Recalls
Class II	24,343
Class I	9,793
Class III	2,887
Not Yet Classified	1

FDA Recall Completed Historical recordClass II

Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for: Accutome Inc 3222 Phoenixville Pike Malvern, PA 19355 USA, Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 63448-411-04

by Altaire Pharmaceuticals, Inc.

Reason: Lack of Assurance of Sterility
Published: November 27, 2019
Distribution: Nationwide

View recall →

FDA Recall Completed Historical recordClass II

CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, Product Size: 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

by Altaire Pharmaceuticals, Inc.

Reason: Lack of Assurance of Sterility
Published: November 27, 2019
Distribution: Nationwide

View recall →

FDA 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
Published: November 27, 2019
Distribution: Nationwide

View recall →

FDA 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
Published: November 27, 2019
Distribution: Nationwide

View recall →

FDA 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
Published: November 27, 2019
Distribution: Nationwide

View recall →

FDA 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
Published: November 27, 2019
Distribution: Nationwide

View recall →

FDA 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
Published: November 27, 2019
Distribution: Nationwide

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FDA 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
Published: November 27, 2019
Distribution: Nationwide

View recall →

FDA 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
Published: November 27, 2019
Distribution: Nationwide

View recall →

FDA 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
Published: November 27, 2019
Distribution: Nationwide

View recall →

FDA 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
Published: November 27, 2019
Distribution: Nationwide

View recall →

FDA 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
Published: November 27, 2019
Distribution: Nationwide

View recall →

FDA 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
Published: November 27, 2019
Distribution: Nationwide

View recall →

FDA 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
Published: November 27, 2019
Distribution: Nationwide

View recall →

FDA 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
Published: November 27, 2019
Distribution: Nationwide

View recall →

FDA 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
Published: November 27, 2019
Distribution: Nationwide

View recall →

FDA 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
Published: November 27, 2019
Distribution: Nationwide

View recall →

FDA 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
Published: November 27, 2019
Distribution: Nationwide

View recall →

FDA 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
Published: November 27, 2019
Distribution: Nationwide

View recall →

FDA 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
Published: November 27, 2019
Distribution: Nationwide

View recall →

Data last updated: September 16, 2026 ET

Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions. Read the full medical disclaimer.