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Recall totals

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

37,143

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

Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sierra-nevada-cheese-company-recalls-graziers-raw-milk-cheese-because-possible-health-riskPublished September 28, 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 29, 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	24,349
Class I	9,799
Class III	2,891
Not Yet Classified	1

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Recalls by class
Class	Recalls
Class II	24,349
Class I	9,799
Class III	2,891
Not Yet Classified	1

FDA Recall Terminated Historical recordClass III

LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22.5 mg, 16 fl oz. (473 mL), Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC: 50991-515-16.

by Poly Pharmaceuticals, Inc

Reason: Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Published: July 23, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate 4 mg, Codeine Phosphate 10 mg, Phenylephrine HCl 7.5 mg, 16 fl oz. (473 mL) Bottle, Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC: 50991-713-16.

by Poly Pharmaceuticals, Inc

Reason: Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Published: July 23, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD, Jerusalem, Israel, NDC 0093-7442-56

by Teva Pharmaceuticals USA

Reason: Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.
Published: July 16, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-10

by Fresenius Kabi USA, LLC

Reason: Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Published: July 16, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-02

by Fresenius Kabi USA, LLC

Reason: Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Published: July 16, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.

by Boehringer Ingelheim Roxane Inc

Reason: Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
Published: July 16, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054 ---- NDC 55566-6500-3

by Ferring Pharmaceuticals Inc

Reason: Discoloration; due to prolonged heat exposure.
Published: July 16, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 USP Heparin Units/mL), 250 mL, Single-Dose Container, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7793-62

by Hospira Inc.

Reason: Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.
Published: July 16, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial, packaged 50/20 mL glass vials/carton, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-2267-20

by Hospira Inc.

Reason: Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
Published: July 16, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India. 30-Count Bottle NDC: 41616-758-83, 90-Count Bottle: NDC 41616-758-81.

by Caraco Pharmaceutical Laboratories, Ltd.

Reason: Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
Published: July 9, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; c) 30-count bottles, NDC 61748-013-30, d) 100-count bottles, NDC 61748-013-01, e) 1000-count bottles, NDC 61748-013-10, Mfd. for: VersaPharm Incorporated, Marietta, GA 30062; Mfd. by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.

by West-Ward Pharmaceutical Corp.

Reason: Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.
Published: July 9, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL (10 mg/mL), 250 mL Single Use IntraVia container, packaged in 10 x 250 mL Single Use IntraVia containers per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1415, NDC 10019-055-61.

by Baxter Healthcare Corp.

Reason: Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Published: July 9, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, Rx Only. Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, Missouri 63045. NDC 0456-1420-07.

by Forest Pharmaceuticals Inc

Reason: Failed Dissolution Specifications: Drug failed stage III dissolution testing.
Published: July 9, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube per carton, Distributed by Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-5315-38, UPC 3 09045 31538 5.

by Bausch & Lomb, Inc.

Reason: Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
Published: July 2, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in a) 1 g tube per carton, professional sample, NDC 24208-385-01, UPC 3 24208-385-01 2; b) 1/8 oz. (3.5 g) tube per carton, NDC 24208-385-55, UPC 3 24208-385-55 5; and c) 1/4 oz. (7 g) Twin Pack, Two 1/8 oz. (3.5 g) tubes per carton, NDC 24208-385-56, UPC 3 24208-385-56 3; Bausch & Lomb Incorporated, Tampa, FL 33637.

by Bausch & Lomb, Inc.

Reason: Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
Published: July 2, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx only, Distributed by Wyeth Pharmaceuticals, Inc., NDC 0008-1211-30

by Pfizer Us Pharmaceutical Group

Reason: Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.
Published: July 2, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02.

by Teva Pharmaceuticals USA

Reason: Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.
Published: July 2, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

PYRIDOXINE HCL, Pyridoxine HCl 100mg, Also Contans: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234

by John W Hollis Inc

Reason: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Published: June 25, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

LIPOTROPIC GOLD, Each mL contains: Levocarnitine 5 mg, Thiamine 50 mg, Riboflavin-5 phosphate 5mg, Niacinimide 50mg, Calcium Pantothenate 5 mg, Cyanocobalamin 1mg, Methionine 12.5mg, Choline 25mg, Inositol 25 mg, Sterile Water For injection, JOHN HOLLIS Pharmacist, Inc,110 20th Avenue N, Nashville, TN 37203, 615-327-3234

by John W Hollis Inc

Reason: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Published: June 25, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 10 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203 615-327-3234

by John W Hollis Inc

Reason: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Published: June 25, 2014
Distribution: Nationwide

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Data last updated: September 29, 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.