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Recall totals

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

37,204

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,841

Class I recallsReasonable probability of serious health consequences

24,366

Class II recallsTemporary or medically reversible health consequences

2,892

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 2,073 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: AS ×
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Recalls announced by month (Year to date)

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Source: FDA and USDA public dataLast updated September 30, 2026 ET

Summary (Year to date)

1,714 recalls have been announced year to date.
Sep 2026 was 3% higher than the previous complete period (Aug 2026: 182).
The highest complete period was Jun 2026 (297).

Recalls by class

Recalls by class
Class	Recalls
Class II	24,366
Class I	9,841
Class III	2,892
Not Yet Classified	2

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Recalls by class
Class	Recalls
Class II	24,366
Class I	9,841
Class III	2,892
Not Yet Classified	2

FDA Recall Terminated Historical recordClass III

G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx Only, Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080

by G & W Laboratories Inc

Reason: Failed Content Uniformity Specifications; at the 18 month time point.
Published: January 8, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc. Amityville, NY 11701. NDC 50383-810-16.

by Hi-Tech Pharmacal Co., Inc.

Reason: Failed Stability Specification; product viscosity and or pH are below specification.
Published: January 1, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-Dose Syringe Cartridges for use with sumatriptan Autoinjector Pen, Manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 for Sandoz Inc., Princeton, NJ 08540, Made in Singapore, NDC 0781-3173-07.

by GlaxoSmithKline, LLC.

Reason: Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Published: January 1, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each containing 6 mg of sumatriptan for subcutaneous injection only, 1 imitrex STATdose Pen, 1 carrying case, Rx only, 6 mg, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in Singapore, NDC 0173-0479-00

by GlaxoSmithKline, LLC.

Reason: Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Published: January 1, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules 15mg, 90 count bottle, Rx only, Manufactured by Catalent Pharma Solutions Winchester, KY 40391 for Amedra Pharmaceuticals, LLC Middlesex, NJ 08846, NDC 52054-514-09

by Amedra Pharmaceuticals LLC

Reason: Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.
Published: January 1, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ NDC 0781-2102-01

by Sandoz Incorporated

Reason: Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
Published: January 1, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

Qnasl (beclomethasone dipropionate) Nasal Aerosol, 80 mcg per spray, 120 metered sprays, 8.7 g inhaler, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Delivery Systems, Northridge, CA 91324, NDC 59310-210-12, UPC 3 59310 21012 9.

by Teva Pharmaceuticals USA

Reason: Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves.
Published: January 1, 2014
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1165-02

by Hospira Inc.

Reason: Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Published: December 25, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1159-02

by Hospira Inc.

Reason: Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Published: December 25, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals, LLC; Schaumburg, IL 60173 NDC 63323-184-11

by Fresenius Kabi USA, LLC

Reason: Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
Published: December 25, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL) bottle, sold under the following labels: (a) CVS pharmacy brand LUBRICANT EYE DROPS FOR MILD TO MODERATE DRY EYE, Distributed by CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 053357 7 and UPC 0 50428 27364 7; (b) equate brand Lubricant Eye Drops, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, UPC 6 81131 03420 3; and (c) up & up brand lubricant eye drops, Dist. by Target Corporation, Minneapolis, MN 55403, UPC 8 58961 79102 0.

by Altaire Pharmaceuticals, Inc.

Reason: Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact that the preservative used in the lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution may not be effective through expiry.
Published: December 25, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear seed, spirulina, starch, kola nut) capsules, 400 mg, 30-count bottles, Distributed by: Bethel, Inc., Tel: (212) 568-5330, UPC 1 60126 41750 9.

by Bethel Nutritional Consulting, Inc

Reason: Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-di-Desmethylsibutramine, and trace amounts of sibutramine and N-Desmethylsibutramine. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.
Published: December 25, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

Quick Thin (citrus aurantium extract, sweet potato fiber, cyamopsis gum powder, alfalfa, mulberry leaf, guarana, spirulina) capsules, 400 mg, 30-count bottle, Distributed by: Bethel, Inc., Tel: (212) 568-5330.

by Bethel Nutritional Consulting, Inc

Reason: Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine, N-Desmethylsibutramine and phenolphthalein. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.
Published: December 25, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 7 9357304140 1

by Zi Xiu Tang Success, LLC

Reason: Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety reasons, making these products unapproved new drugs.
Published: December 25, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass I

Classic Zi Xiu Tang, Bee Pollen Capsule, Net Wt. 250 mg x 60 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 6 937000 700019

by Zi Xiu Tang Success, LLC

Reason: Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety reasons, making these products unapproved new drugs.
Published: December 25, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for Direct Infusion, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. NDC: 0338-0644-06.

by Baxter Healthcare Corp.

Reason: Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured
Published: December 25, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass II

Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mfd by: Shasun Chemicals and Drugs Limited, Unit II, R. S. Na 32, 33, 743 PIMS Rd, Periyakalepet, Pondicherry. 605014 INDIA. NDC 0143-9749-10.

by West-Ward Pharmaceutical Corp.

Reason: Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing
Published: December 25, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

BFF's are COOL! Justice, CHERRY SCENT ANTI BAC, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5

by Tween Brands Inc

Reason: Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Published: December 25, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

yum yum bubble gum Justice, BUBBLEGUM SCENT ANTI BAC, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5

by Tween Brands Inc

Reason: Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Published: December 25, 2013
Distribution: Nationwide

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FDA Recall Terminated Historical recordClass III

YOU CANT HANDLE THIS Justice, GRAPE SCENT ANTI BAC, Ethyl Alcohol Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5

by Tween Brands Inc

Reason: Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%.
Published: December 25, 2013
Distribution: Nationwide

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Data last updated: September 30, 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.