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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: UT ×
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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 Terminated Historical recordClass III

PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161, Mfg. for Respond Industries First Aid, Mason, OH 45040 (Shipping Label)

by Ultra Seal Corporation

Reason: Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Published: November 3, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister packs, Manufactured by: Ohm Laboratories Inc., 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 63981-724-15

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Failed Moisture Limits
Published: November 3, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister packs, Distributed By Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-5833-15

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Failed Moisture Limits
Published: November 3, 2021
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Published: November 3, 2021
Distribution: 494 patients/consumers received prescrip…

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FDA Recall Terminated Historical recordClass II

PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Published: November 3, 2021
Distribution: 494 patients/consumers received prescrip…

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FDA Recall Terminated Historical recordClass II

MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Published: November 3, 2021
Distribution: 494 patients/consumers received prescrip…

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FDA Recall Terminated Historical recordClass II

MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Published: November 3, 2021
Distribution: 494 patients/consumers received prescrip…

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FDA Recall Terminated Historical recordClass II

MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Published: November 3, 2021
Distribution: 494 patients/consumers received prescrip…

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FDA Recall Terminated Historical recordClass II

MIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Published: November 3, 2021
Distribution: 494 patients/consumers received prescrip…

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FDA Recall Terminated Historical recordClass II

METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Published: November 3, 2021
Distribution: 494 patients/consumers received prescrip…

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FDA Recall Terminated Historical recordClass II

METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Published: November 3, 2021
Distribution: 494 patients/consumers received prescrip…

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FDA Recall Terminated Historical recordClass II

METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Published: November 3, 2021
Distribution: 494 patients/consumers received prescrip…

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FDA Recall Terminated Historical recordClass II

METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Published: November 3, 2021
Distribution: 494 patients/consumers received prescrip…

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FDA Recall Terminated Historical recordClass II

FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Published: November 3, 2021
Distribution: 494 patients/consumers received prescrip…

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FDA Recall Terminated Historical recordClass II

CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Published: November 3, 2021
Distribution: 494 patients/consumers received prescrip…

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FDA Recall Terminated Historical recordClass II

BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Published: November 3, 2021
Distribution: 494 patients/consumers received prescrip…

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FDA Recall Terminated Historical recordClass II

ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Published: November 3, 2021
Distribution: 494 patients/consumers received prescrip…

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FDA Recall Terminated Historical recordClass II

ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Published: November 3, 2021
Distribution: 494 patients/consumers received prescrip…

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FDA Recall Terminated Historical recordClass II

VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Published: November 3, 2021
Distribution: 494 patients/consumers received prescrip…

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FDA Recall Terminated Historical recordClass II

VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx

by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Published: November 3, 2021
Distribution: 494 patients/consumers received prescrip…

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.