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Recall totals

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

36,950

Total recall recordsAll FDA and USDA recalls in Public Health Trace

9,732

Class I recallsReasonable probability of serious health consequences

24,263

Class II recallsTemporary or medically reversible health consequences

2,873

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 2,071 recalls

Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/made-fresh-salads-inc-recalls-ready-eat-deli-style-salads-and-cream-cheese-because-possible-healthPublished September 6, 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 7, 2026 ET

Summary (Year to date)

1,458 recalls have been announced year to date.
Aug 2026 was 53% 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	24,263
Class I	9,732
Class III	2,873
Not Yet Classified	1

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Recalls by class
Class	Recalls
Class II	24,263
Class I	9,732
Class III	2,873
Not Yet Classified	1

FDA Recall Ongoing Historical recordClass II

Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10

by Golden State Medical Supply Inc.

Reason: Presence of Foreign Tablets/Capsules
Published: December 24, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Rx only, Made in Canada by Novocol Pharmaceutical of Canada, Inc., Distributed by Septodont, Inc., Louisville, Co, 80027, NDC 0362-0101-10

by Novocol Pharmaceutical of Canada, Inc.

Reason: Defective container: cracked/broken cartridges
Published: December 24, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Single-Dose Cartridges, 1.7 mL, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0753-05.

by Novocol Pharmaceutical of Canada, Inc.

Reason: Defective container: cracked/broken cartridges
Published: December 24, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distributed by Benco Dental 295 Center Point Blvd, Pittston, PA 18640, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66975-406-51.

by Novocol Pharmaceutical of Canada, Inc.

Reason: Defective container: cracked/broken cartridges
Published: December 24, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66467-9760-5.

by Novocol Pharmaceutical of Canada, Inc.

Reason: Defective container: cracked/broken cartridges
Published: December 24, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-441-16.

by Novocol Pharmaceutical of Canada, Inc.

Reason: Defective container: cracked/broken cartridges
Published: December 24, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Patterson Dental Supply, Inc., 1031 Mendota Heights Road, Saint Paul, MN55120, Manufactured by: Novocol Pharmaceutical of Canada, Inc., NDC 50227-1030-5.

by Novocol Pharmaceutical of Canada, Inc.

Reason: Defective container: cracked/broken cartridges
Published: December 24, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-176-16.

by Novocol Pharmaceutical of Canada, Inc.

Reason: Defective container: cracked/broken cartridges
Published: December 24, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.

by Lupin Pharmaceuticals Inc.

Reason: Defective container - seal not adhering to bottles
Published: December 17, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02

by Cipla USA, Inc.

Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Published: December 17, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02

by Cipla USA, Inc.

Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Published: December 17, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02

by Cipla USA, Inc.

Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Published: December 17, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, Winder, GA 30680. NDC: 75826-131-01

by Winder Laboratories, LLC

Reason: Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Published: December 17, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 38478, Product of Italy, NDC 42291-874-90.

by Glenmark Pharmaceuticals Inc., USA

Reason: Cross Contamination with Other Products
Published: December 17, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67226. NDC: 71266-8240-01

by Fagron Compounding Services

Reason: Incorrect Product Formulation
Published: December 17, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56

by Dr. Reddy's Laboratories, Inc.

Reason: Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Published: December 17, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33422, Carton NDC 76282-478-90; Bottle NDC 76282-478-13.

by Cipla USA, Inc.

Reason: Failed stability specifications: Out of specification for hardness test
Published: December 17, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-936-98.

by Cipla USA, Inc.

Reason: Failed stability specifications: Out of specification for hardness test
Published: December 17, 2025
Distribution: Nationwide

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FDA Recall United States Ongoing Historical recordClass I

ByHeart, INC.

Product: 1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 gra…
Reason: Contaminated with Clostridium botulinum
Published: December 17, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.

by Breckenridge Pharmaceutical, Inc.

Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Published: December 10, 2025
Distribution: Nationwide

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Data last updated: September 7, 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.