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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: RI ×
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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

Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-050-88.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Published: November 5, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-049-88.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Published: November 5, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-047-88.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Published: November 5, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-046-88.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Published: November 5, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37

by Otsuka ICU Medical LLC

Reason: Lack of Assurance of Sterility: Potential for flexible container leaks.
Published: November 5, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-119-91

by ENDO USA, Inc.

Reason: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Published: November 5, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-128-91

by ENDO USA, Inc.

Reason: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Published: November 5, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91

by ENDO USA, Inc.

Reason: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Published: November 5, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass III

Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-125-91

by ENDO USA, Inc.

Reason: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Published: November 5, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Testosterone / Triamcinolone Acetonide Pellet (200MG/40MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0364-01

by FARMAKEIO OUTSOURCING LLC

Reason: CGMP Deviations: Potential presence of metal particulate matter
Published: November 5, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0367-01

by FARMAKEIO OUTSOURCING LLC

Reason: CGMP Deviations: Potential presence of metal particulate matter
Published: November 5, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Testosterone / Triamcinolone Acetonide 87.5MG/17.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0382-01

by FARMAKEIO OUTSOURCING LLC

Reason: CGMP Deviations: Potential presence of metal particulate matter
Published: November 5, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0366-01

by FARMAKEIO OUTSOURCING LLC

Reason: CGMP Deviations: Potential presence of metal particulate matter
Published: November 5, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0365-01

by FARMAKEIO OUTSOURCING LLC

Reason: CGMP Deviations: Potential presence of metal particulate matter
Published: November 5, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Testosterone / Triamcinolone Acetonide Pellet (37.5MG/7.5MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0380-01

by FARMAKEIO OUTSOURCING LLC

Reason: CGMP Deviations: Potential presence of metal particulate matter
Published: November 5, 2025
Distribution: Nationwide

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FDA Recall Ongoing Historical recordClass II

Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0379-01

by FARMAKEIO OUTSOURCING LLC

Reason: CGMP Deviations: Potential presence of metal particulate matter
Published: November 5, 2025
Distribution: Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0363-01

by FARMAKEIO OUTSOURCING LLC

Reason: CGMP Deviations: Potential presence of metal particulate matter
Published: November 5, 2025
Distribution: Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0402-01

by FARMAKEIO OUTSOURCING LLC

Reason: CGMP Deviations: Potential presence of metal particulate matter
Published: November 5, 2025
Distribution: Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Testosterone Regular Release 50 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0401-01

by FARMAKEIO OUTSOURCING LLC

Reason: CGMP Deviations: Potential presence of metal particulate matter
Published: November 5, 2025
Distribution: Nationwide

View recall →

FDA Recall Ongoing Historical recordClass II

Testosterone 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0381-01

by FARMAKEIO OUTSOURCING LLC

Reason: CGMP Deviations: Potential presence of metal particulate matter
Published: November 5, 2025
Distribution: Nationwide

View recall →

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.