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Recall totals

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

37,118

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/gf-blends-recalls-truly-aip-all-purpose-flour-and-bread-mix-and-eat-gangster-flat-bread-pizza-mixPublished September 18, 2026

Most affected stateHawaii 200 recalls mention this state

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

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Source: FDA and USDA public dataLast updated September 20, 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

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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

Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-05

by Mylan Pharmaceuticals Inc.

Reason: Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Published: September 19, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01

by Mylan Pharmaceuticals Inc.

Reason: Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Published: September 19, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11

by Par Pharmaceutical, Inc.

Reason: Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
Published: September 19, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01

by Pfizer Inc.

Reason: Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Published: September 19, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 30062. Mfg By: Swiss Caps AG, Kirchberg, Switzerland. NDC: 61748-025-01

by Akorn, Inc.

Reason: Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
Published: September 12, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-888-90

by Avkare Incorporated

Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Published: September 12, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-886-90

by Avkare Incorporated

Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Published: September 12, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-887-90

by Avkare Incorporated

Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Published: September 12, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-885-90

by Avkare Incorporated

Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Published: September 12, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-884-90

by Avkare Incorporated

Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Published: September 12, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in boxes of 20 cups), Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977 Dist. By: McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd. Concord, NC 28027, NDC 63739-549-51

by MCKESSON CORPORATION

Reason: Supterpotent Drug
Published: September 12, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Parsippany, NJ 07054 USA, NDC 30698-911-15

by Validus Pharmaceuticals, Inc.

Reason: Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Published: September 5, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59

by Validus Pharmaceuticals, Inc.

Reason: Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Published: September 5, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ (120 ml) bottle, Pfizer, Madison, NJ 07940 USA, NDC 0573-0207-30, UPC 3-0573-0207-30-0

by Pfizer Global Supply

Reason: Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.
Published: September 5, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-718-10

by Akorn, Inc.

Reason: Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Published: September 5, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Methyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

by Auro Pharmacies, Inc.

Reason: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Published: September 5, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Folic Acid injectable, 10 mg/ml, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

by Auro Pharmacies, Inc.

Reason: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Published: September 5, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

by Auro Pharmacies, Inc.

Reason: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Published: September 5, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in a) 5 mL and 8 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

by Auro Pharmacies, Inc.

Reason: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Published: September 5, 2018
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

by Auro Pharmacies, Inc.

Reason: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Published: September 5, 2018
Distribution: Nationwide

View recall →

Data last updated: September 20, 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.