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Recall totals

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

37,142
Total recall recordsAll FDA and USDA recalls in Public Health Trace
9,799
Class I recallsReasonable probability of serious health consequences
24,349
Class II recallsTemporary or medically reversible health consequences
2,891
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
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 II24,349
Class I9,799
Class III2,891
Not Yet Classified1
Download CSV
Recalls by class
ClassRecalls
Class II24,349
Class I9,799
Class III2,891
Not Yet Classified1

Showing 15,141–15,160 of 17,335 recalls

FDA Recall Terminated Historical recordClass II

Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121

by Prometheus Laboratories Inc.

Reason
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Published
November 26, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Assured Naproxen Sodium Tablets, USP 220 mg., 15 count bottle, Repackaged by Contract Packaging Resources, Inc 8009 Industrial Village Road Greensboro, NC 27409 Distributed by Greenbrier International, Inc Chesapeake, VA 23320

by Contract Packaging Resources Inc.

Reason
Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were packaged into cartons of Assured Naproxen Sodium Tablets, USP
Published
November 19, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01

by Fresenius Kabi USA LLC

Reason
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
Published
November 19, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0135-15 (15 g) and NDC 0168-0135-60 (60 g)

by Fougera Pharmaceuticals Inc.

Reason
Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.
Published
November 19, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-3621-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326

by Apotex Inc.

Reason
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Published
November 12, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326

by Apotex Inc.

Reason
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Published
November 12, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3619-3

by Apotex Inc.

Reason
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Published
November 12, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3618-3

by Apotex Inc.

Reason
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Published
November 12, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-4788-10

by Pharmaceutical Associates Inc

Reason
Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified impurity at the 12 month stability test point.
Published
November 12, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Loratadine 24 HR-OTC,10 mg, 30-count bottle, Manufactured by Novartis Consumer Health, Parsippany, NJ 07054, Distributed by Physicians Total Care, Tulsa OK 74146, NDC 54868-5268-00

by Physicians Total Care, Inc.

Reason
Failed Tablet/Capsule Specifications: Affected lot numbers may contain chipped or broken tablets.
Published
November 12, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles and 90-count bottles, RX only, Manufactured for Sun Pharma Global Inc. Dubai, United Arab Emirates by Sun Pharmaceutical Industries Limited, Halol, India

by Sun Pharma Global Inc.

Reason
Failed Dissolution Specifications; 12 month stability time point
Published
November 12, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL and 1 vial of 2.2 mL DILUENT per carton, Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101; Diluent  MADE IN ITALY; NDC 0008-1179-01.

by Pfizer Inc.

Reason
Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. The TORISEL vials are not affected by this issue.
Published
November 12, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Obagi Nu-Derm Clear, AM PM 3, Skin Bleaching and Corrector Cream, Hydroquinone USP, 4%, Rx Only, Net Wt. 2 OZ. (57 g) bottle, Dist by OMP Inc, Long Beach CA 90802, Made in USA, NDC 62032-101-36

by Obagi Medical Products

Reason
Labeling: Label Mix-Up; Containers of the Obagi Nu-Derm Clear pre-labeled bottles were inadvertently introduced into the Obagi Exfoderm Forte packaging line. Therefore customers which ordered Clear RX actually had contents of Exfoderm forte.
Published
November 12, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Vancomycin Hydrochloride Capsule, USP, 250 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc. Parsippany, NJ 07054 USA, Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA ---- NDC 0591-3561-15 UPC 3-3-0591356115-1

by Actavis Inc

Reason
Subpotent Drug
Published
November 5, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc. Parsippany, NJ 07054 USA, Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA ---- NDC 0591-3560-15 UPC Code 3-0591356015-4

by Actavis Inc

Reason
Subpotent Drug
Published
November 5, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

All products, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613

by Specialty Compounding, LLC

Reason
Lack of Assurance of Sterility
Published
November 5, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

CALCIUM GLUCONATE 2 gm (PF) PRESERVATIVE FREE in 100 mL Sodium Chloride 0.9% for Injection, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613

by Specialty Compounding, LLC

Reason
Non Sterility: Microbial contamination
Published
November 5, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

CUBICIN (daptomycin for injection) 500 mg, For Intravenous Use Only, Rx Only, Single use Vial, Manufactured for: Cubist Pharmaceuticals Inc., Lexington, MA 02421, USA, NDC 67919-011-01

by Cubist Pharmaceuticals, Inc.

Reason
Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at the bottom of the vial following reconstitution.
Published
November 5, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Fentanyl/bupivacaine 3000 mcg/30 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

by Martin Avenue Pharmacy, Inc.

Reason
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Published
November 5, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Voriconazole 10 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

by Martin Avenue Pharmacy, Inc.

Reason
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Published
November 5, 2014
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.