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Recall totals

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

36,949

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,732

Class I recallsReasonable probability of serious health consequences

24,263

Class II recallsTemporary or medically reversible health consequences

2,873

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 2,071 recalls

Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/foods-alive-recalls-organic-moringa-leaf-powder-because-possible-health-riskPublished September 4, 2026

Most affected stateHawaii 200 recalls mention this state

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

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Source: FDA and USDA public dataLast updated September 5, 2026 ET

Summary (Year to date)

1,458 recalls have been announced year to date.
Aug 2026 was 53% 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	24,263
Class I	9,732
Class III	2,873
Not Yet Classified	1

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Recalls by class
Class	Recalls
Class II	24,263
Class I	9,732
Class III	2,873
Not Yet Classified	1

FDA Recall Ongoing 2026 recordClass II

Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case).

by Precision Dose Inc.

Reason: Failed Impurities/Degradation Specifications
Published: July 29, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass III

Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10.

by Ascend Laboratories, LLC

Reason: Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Published: July 29, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass III

Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.

by Ascend Laboratories, LLC

Reason: Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Published: July 29, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass I

Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-401-10.

by JB Chemicals and Pharmaceuticals Ltd

Reason: Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
Published: July 29, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03

by Fresenius Kabi USA, LLC

Reason: Presence of Particulate Matter: Hair was found in products
Published: July 29, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01

by Fresenius Kabi USA, LLC

Reason: Presence of Particulate Matter: Hair was found in products
Published: July 29, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05

by Fresenius Kabi USA, LLC

Reason: Presence of Particulate Matter: Hair was found in products
Published: July 29, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-208-01

by Fresenius Kabi USA, LLC

Reason: Presence of Particulate Matter: Hair was found in products
Published: July 29, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07

by Fresenius Kabi USA, LLC

Reason: Presence of Particulate Matter: Hair was found in product
Published: July 29, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ, Manufactured by: Lyne Laboratories, Inc., Brockton, MA. NDC 64980-504-48.

by Rising Pharma Holding, Inc.

Reason: Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Published: July 29, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1

by Rohto-Mentholatum (Vietnam) Co., Ltd.

Reason: Lack of Assurance of Sterility
Published: July 29, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2

by Rohto-Mentholatum (Vietnam) Co., Ltd.

Reason: Lack of Assurance of Sterility
Published: July 29, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135, NDC 10742-8162-1

by Rohto-Mentholatum (Vietnam) Co., Ltd.

Reason: Lack of Assurance of Sterility
Published: July 29, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1

by Rohto-Mentholatum (Vietnam) Co., Ltd.

Reason: Lack of Assurance of Sterility
Published: July 29, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010916, NDC 10742-8160-1

by Rohto-Mentholatum (Vietnam) Co., Ltd.

Reason: Lack of Assurance of Sterility
Published: July 29, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2

by Rohto-Mentholatum (Vietnam) Co., Ltd.

Reason: Lack of Assurance of Sterility
Published: July 29, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1

by Rohto-Mentholatum (Vietnam) Co., Ltd.

Reason: Lack of Assurance of Sterility
Published: July 29, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam UPC 310742010862, NDC 10742-8146-1

by Rohto-Mentholatum (Vietnam) Co., Ltd.

Reason: Lack of Assurance of Sterility
Published: July 29, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500-30

by Ascend Laboratories, LLC

Reason: Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Published: July 29, 2026
Distribution: Nationwide

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FDA Recall Ongoing 2026 recordClass II

Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3563-0; NDC Blister: 0904-6956-61

by MAJOR PHARMACEUTICALS

Reason: Subpotent Drug
Published: July 29, 2026
Distribution: Nationwide

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Data last updated: September 5, 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.