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Research historical outbreak investigations and the full recall archive, with charts, trends, and advanced filters. Looking for what's happening right now instead? See current Health Alerts.

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

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)

  • 1,527 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

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

Recalls by class
ClassRecalls
Class II24,313
Class I9,786
Class III2,876
Not Yet Classified2
Download CSV
Recalls by class
ClassRecalls
Class II24,313
Class I9,786
Class III2,876
Not Yet Classified2

Showing 5,441–5,460 of 17,299 recalls

FDA Recall Terminated Historical 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

View recall →

FDA Recall Terminated Historical 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

View recall →

FDA Recall Terminated Historical 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

View recall →

FDA Recall Terminated Historical 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

View recall →

FDA Recall Terminated Historical 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

View recall →

FDA Recall Terminated Historical 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

View recall →

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

View recall →

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

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 Terminated Historical 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 Terminated Historical 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

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FDA Recall Terminated Historical recordClass II

AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-129-06.

by Teva Pharmaceuticals USA

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

View recall →

FDA Recall Terminated Historical recordClass II

AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA 19355, Manufactured in Ireland, NDC 59310-111-06

by Teva Pharmaceuticals USA

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

View recall →

FDA Recall Terminated Historical recordClass II

AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-530-08.

by Teva Pharmaceuticals USA

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

View recall →

FDA Recall Terminated Historical recordClass II

AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC , Frazer, PA 19355, Manufactured in Ireland, NDC 59310-520-08

by Teva Pharmaceuticals USA

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

View recall →

FDA Recall Terminated Historical recordClass II

GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx only, Manufactured by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054. Carton NDC#: 68084-295-21 (Individual Dose NDC: 68084-295-11)

by American Health Packaging

Reason
Failed Dissolution Specifications: results were above specification.
Published
October 27, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial, Rx only, Manufactured for: Piramal Critical Care, Bethlehem, PA 18017, USA, Manufactured by: Sanovel Ilac, San. Ve Tic. A.S. Istanbul, Turkey, NDC 66794-0228-41

by Piramal Critical Care, Inc.

Reason
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
Published
October 27, 2021
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7

by Beiersdorf Inc

Reason
cGMP Deviations
Published
October 27, 2021
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4

by Beiersdorf Inc

Reason
cGMP Deviations
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.