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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 621–640 of 17,898 drug recalls

Drug Recall Ongoing Historical recordClass II

Lisdexamfetamine Dimesylate Capsules, 60 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 57664-051-88.

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.
Recall initiated
October 28, 2025
Reported by FDA
November 5, 2025
Distribution
U.S Nationwide.

View recall →

Drug 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.
Recall initiated
October 28, 2025
Reported by FDA
November 5, 2025
Distribution
U.S Nationwide.

View recall →

Drug 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.
Recall initiated
October 28, 2025
Reported by FDA
November 5, 2025
Distribution
U.S Nationwide.

View recall →

Drug 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.
Recall initiated
October 28, 2025
Reported by FDA
November 5, 2025
Distribution
U.S Nationwide.

View recall →

Drug 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.
Recall initiated
October 28, 2025
Reported by FDA
November 5, 2025
Distribution
U.S Nationwide.

View recall →

Drug 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.
Recall initiated
October 27, 2025
Reported by FDA
November 5, 2025
Distribution
Distributed Nationwide in the USA.

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Drug 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.
Recall initiated
October 10, 2025
Reported by FDA
November 5, 2025
Distribution
Nationwide within the United States

View recall →

Drug 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.
Recall initiated
October 10, 2025
Reported by FDA
November 5, 2025
Distribution
Nationwide within the United States

View recall →

Drug 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.
Recall initiated
October 10, 2025
Reported by FDA
November 5, 2025
Distribution
Nationwide within the United States

View recall →

Drug 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.
Recall initiated
October 10, 2025
Reported by FDA
November 5, 2025
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing Historical recordClass III

Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604

by Letco Medical LLC

Reason
Labeling: Not Elsewhere Classified
Recall initiated
September 12, 2025
Reported by FDA
November 5, 2025
Distribution
Product was distributed to: Letco Medical, LLC 1316 Commerce Drive Decatur, AL 35601 Product was further distributed to 44 compounding pharmacies and 2 distributors.

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Drug 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
Recall initiated
October 14, 2025
Reported by FDA
November 5, 2025
Distribution
Nationwide in the USA and Antigua

View recall →

Drug 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
Recall initiated
October 14, 2025
Reported by FDA
November 5, 2025
Distribution
Nationwide in the USA and Antigua

View recall →

Drug 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
Recall initiated
October 14, 2025
Reported by FDA
November 5, 2025
Distribution
Nationwide in the USA and Antigua

View recall →

Drug 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
Recall initiated
October 14, 2025
Reported by FDA
November 5, 2025
Distribution
Nationwide in the USA and Antigua

View recall →

Drug 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
Recall initiated
October 14, 2025
Reported by FDA
November 5, 2025
Distribution
Nationwide in the USA and Antigua

View recall →

Drug 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
Recall initiated
October 14, 2025
Reported by FDA
November 5, 2025
Distribution
Nationwide in the USA and Antigua

View recall →

Drug 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
Recall initiated
October 14, 2025
Reported by FDA
November 5, 2025
Distribution
Nationwide in the USA and Antigua

View recall →

Drug 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
Recall initiated
October 14, 2025
Reported by FDA
November 5, 2025
Distribution
Nationwide in the USA and Antigua

View recall →

Drug 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
Recall initiated
October 14, 2025
Reported by FDA
November 5, 2025
Distribution
Nationwide in the USA and Antigua

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.