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Recall totals

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

37,448
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,872
Class I recallsReasonable probability of serious health consequences
24,509
Class II recallsTemporary or medically reversible health consequences
2,932
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 2,096 recalls
Most affected stateHawaii 200 recalls mention this state

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Download matching recalls as CSV

CSV exports include up to 5,000 matching rows (applying your current filters), not the full dataset if it's larger.

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Recalls announced by month (Year to date)

A chart of recalls grouped by month.

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Source: FDA and USDA public dataLast updated

Summary (Year to date)

  • 1,956 recalls have been announced year to date.
  • Oct 2026 was 4% higher than the previous complete period (Sep 2026: 209).
  • The highest complete period was Jun 2026 (300).
  • Nov 2026 is incomplete and not included in the figures above.
  • Complete data
  • Incomplete
Recalls by class

A bar chart of the total number of recalls in this dataset by recall class.

Recalls by class
ClassRecalls
Class II24,509
Class I9,872
Class III2,932
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,509
Class I9,872
Class III2,932
Not Yet Classified2

Showing 6,221–6,240 of 18,373 recalls

FDA Recall United States TerminatedTerminated: March 3, 2022Historical recordClass II

Pepsico Inc

Product
Starbucks Doubleshot Espresso, Espresso & Salted Caramel Cre…
Reason
An issue with adequate sealing of canned coffee products potentially lead to premature spoilage.
Published
November 10, 2021
Distribution
Nationwide

View recall →

FDA Recall United States TerminatedTerminated: March 3, 2022Historical recordClass II

Pepsico Inc

Product
Starbucks Doubleshot Espresso, Espresso & Light Cream, 6.5 F…
Reason
An issue with adequate sealing of canned coffee products potentially lead to premature spoilage.
Published
November 10, 2021
Distribution
Nationwide

View recall →

FDA Recall United States TerminatedTerminated: March 3, 2022Historical recordClass II

Pepsico Inc

Product
Starbucks Doubleshot Espresso, Espresso & Cream, 6.5 FL OZ U…
Reason
An issue with adequate sealing of canned coffee products potentially lead to premature spoilage.
Published
November 10, 2021
Distribution
Nationwide

View recall →

FDA Recall TerminatedTerminated: August 23, 2022Historical recordClass III

Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.

by Lupin Pharmaceuticals Inc.

Reason
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Published
November 3, 2021
Distribution
Nationwide

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FDA Recall TerminatedTerminated: April 24, 2024Historical recordClass III

Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-094-41

by MACLEODS PHARMA USA, INC

Reason
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Published
November 3, 2021
Distribution
Nationwide

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FDA Recall TerminatedTerminated: April 24, 2024Historical recordClass III

Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-093-41

by MACLEODS PHARMA USA, INC

Reason
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Published
November 3, 2021
Distribution
Nationwide

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FDA Recall TerminatedTerminated: April 24, 2024Historical recordClass III

Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18 Tablets (3 x 6 Unit-Dose Tablets, NDC 33342-088-41) Rx only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536l Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA

by MACLEODS PHARMA USA, INC

Reason
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Published
November 3, 2021
Distribution
Nationwide

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FDA Recall TerminatedTerminated: March 28, 2022Historical recordClass III

Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, PO# 19540, Mfg. for: Afassco Minden, NV 89423 (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 TerminatedTerminated: March 28, 2022Historical recordClass III

Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, 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 TerminatedTerminated: March 28, 2022Historical recordClass III

Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (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 TerminatedTerminated: March 28, 2022Historical recordClass III

North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) tablets, 2 tablets per packet, Packaged in 5,000 Packets/Case, PO# B121242, Item# 853500-01, Dist. By Honeywell Safety Products USA, Smithfield, RI 02917

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 TerminatedTerminated: March 28, 2022Historical recordClass III

AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000 Packets/Case, PO# 11938, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989 (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 TerminatedTerminated: March 28, 2022Historical recordClass III

ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC 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 TerminatedTerminated: March 28, 2022Historical recordClass III

Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets/pk, packaged in 10,000 packets, PO# 8967, Mfg. for Tellus/The Provision First Aid Line (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 TerminatedTerminated: March 28, 2022Historical 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 TerminatedTerminated: August 31, 2023Historical 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 TerminatedTerminated: August 31, 2023Historical 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 TerminatedTerminated: March 13, 2023Historical recordClass II

Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 UNited States. Manufactured by: Lupin Limited, Pithampur, (M.P.) 454 775 India NDC# 68180-316-06

by Lupin Pharmaceuticals Inc.

Reason
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Published
October 27, 2021
Distribution
Nationwide

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FDA Recall TerminatedTerminated: December 6, 2022Historical recordClass II

Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC 70000-0232-1

by Dr. Reddy's Laboratories, Inc.

Reason
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Published
October 27, 2021
Distribution
Nationwide

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FDA Recall TerminatedTerminated: February 16, 2023Historical recordClass II

AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-136-06

by Teva Pharmaceuticals USA

Reason
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Published
October 27, 2021
Distribution
Nationwide

View recall →

Data last updated:

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.

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