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Recall totals

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

37,066

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,786

Class I recallsReasonable probability of serious health consequences

24,313

Class II recallsTemporary or medically reversible health consequences

2,876

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/whole-foods-market-issues-allergy-alert-undeclared-egg-cabricharme-cheesePublished September 11, 2026

Most affected stateHawaii 200 recalls mention this state

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

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Source: FDA and USDA public dataLast updated September 13, 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	24,313
Class I	9,786
Class III	2,876
Not Yet Classified	2

Recalls by class
Class	Recalls
Class II	24,313
Class I	9,786
Class III	2,876
Not Yet Classified	2

FDA Recall Terminated Historical recordClass II

Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.

by CIPLA

Reason: Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Published: September 14, 2022
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50.

by CIPLA

Reason: Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Published: September 14, 2022
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35

by Akorn, Inc.

Reason: cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Published: September 14, 2022
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31

by Akorn, Inc.

Reason: cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Published: September 14, 2022
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorphan 5 mg per 5 mL) 2.04FL. OZ (60mL), packaged in 12-5 individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-321-05 UPC 8 60003 67146 7

by Plastikon Healthcare LLC

Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Published: September 14, 2022
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packaged in 12-5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-311-05 UPC 8 60003 67145 0

by Plastikon Healthcare LLC

Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Published: September 14, 2022
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL), 2.04 FL. OZ (60 mL) packaged in 12- 5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-302-05 UPC 8 60003 67144 3

by Plastikon Healthcare LLC

Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Published: September 14, 2022
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6980-72

by Plastikon Healthcare LLC

Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Published: September 14, 2022
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152. NDC 0904-6844-70

by Plastikon Healthcare LLC

Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Published: September 14, 2022
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6741-72

by Plastikon Healthcare LLC

Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Published: September 14, 2022
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6740-70

by Plastikon Healthcare LLC

Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Published: September 14, 2022
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cups per tray, 4 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-7098-94

by Plastikon Healthcare LLC

Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Published: September 14, 2022
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6820-76

by Plastikon Healthcare LLC

Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Published: September 14, 2022
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6739-71

by Plastikon Healthcare LLC

Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Published: September 14, 2022
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6738-70

by Plastikon Healthcare LLC

Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Published: September 14, 2022
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6839-73

by Plastikon Healthcare LLC

Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Published: September 14, 2022
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6838-73

by Plastikon Healthcare LLC

Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Published: September 14, 2022
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6840-72.

by Plastikon Healthcare LLC

Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Published: September 14, 2022
Distribution: Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6846-73.

by Plastikon Healthcare LLC

Reason: CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Published: September 14, 2022
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6839-73

by Plastikon Healthcare LLC

Reason: Microbial Contamination of Non-Sterile Products.
Published: September 14, 2022
Distribution: Nationwide

View recall →

Data last updated: September 13, 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.