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Public Health Trace collects, organizes, connects, and explains official recall, outbreak, surveillance, travel-health, and air-quality records from CDC, FDA, USDA, WHO, EPA, and other public sources. It also publishes original educational guides to help readers understand these records. Every imported record remains attributed and linked to its official source. It is an independent information service, not a medical provider, and not a substitute for professional medical advice or your local public health department's own guidance.

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Policy version 2026-07-21, effective July 21, 2026.

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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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Drug Recall Ongoing Historical recordClass III

Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30

by Alembic Pharmaceuticals Limited

Reason: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Recall initiated: October 10, 2025
Reported by FDA: November 26, 2025
Distribution: Nationwide in the USA.

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Drug Recall Ongoing Historical recordClass II

Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for AERO HEALTHCARE US, Valley-Cottage, NY, 10989, NDC 55305-135-01

by Aero Healthcare

Reason: Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
Recall initiated: October 17, 2025
Reported by FDA: November 12, 2025
Distribution: US Nationwide.

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Drug Recall Ongoing Historical recordClass II

clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India.

by Zydus Pharmaceuticals (USA) Inc

Reason: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Recall initiated: October 22, 2025
Reported by FDA: November 12, 2025
Distribution: Nationwide in the US

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Drug Recall Ongoing Historical recordClass II

clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India

by Zydus Pharmaceuticals (USA) Inc

Reason: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Recall initiated: October 22, 2025
Reported by FDA: November 12, 2025
Distribution: Nationwide in the US

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Drug Recall Ongoing Historical recordClass II

clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India

by Zydus Pharmaceuticals (USA) Inc

Reason: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Recall initiated: October 22, 2025
Reported by FDA: November 12, 2025
Distribution: Nationwide in the US

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Drug Recall Ongoing Historical recordClass II

Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-2277-7.

by Teva Pharmaceuticals USA, Inc

Reason: Subpotent drug; Clavulanate Potassium component
Recall initiated: October 13, 2025
Reported by FDA: November 12, 2025
Distribution: Distributed in three (3) States: MS, OH, CA.

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Drug Recall Ongoing Historical recordClass II

Lisdexamfetamine Dimesylate Capsules, 30 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 57664-048-88.

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.

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Drug Recall Ongoing Historical recordClass II

Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.

by Heritage Pharmaceuticals Inc

Reason: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Recall initiated: October 6, 2025
Reported by FDA: November 5, 2025
Distribution: U.S. Nationwide.

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Drug Recall Ongoing Historical recordClass II

Lisdexamfetamine Dimesylate Capsules, 70 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 57664-052-88.

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.

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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.

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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.

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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.

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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.

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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.

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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

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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

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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

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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

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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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Data last updated: October 30, 2026 ET

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.