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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 II

Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 801 Broad St Ste 200, Chattanooga, TN 37402. NDC 71687-0011-1

by Denison Pharmaceuticals, LLC

Reason: Chemical Contamination: Presence of benzene.
Recall initiated: February 24, 2025
Reported by FDA: March 19, 2025
Distribution: Nationwide within the USA

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Drug Recall Ongoing Historical recordClass I

PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, 855-275-2270, NDC 71285-6092-1.

by Central Admixture Pharmacy Services, Inc.

Reason: Presence of Particulate Matter
Recall initiated: February 20, 2025
Reported by FDA: March 19, 2025
Distribution: Product was distributed nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05

by Breckenridge Pharmaceutical, Inc.

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Recall initiated: February 28, 2025
Reported by FDA: March 19, 2025
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10

by Breckenridge Pharmaceutical, Inc.

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Recall initiated: February 28, 2025
Reported by FDA: March 19, 2025
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass II

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

by Breckenridge Pharmaceutical, Inc.

Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Recall initiated: February 28, 2025
Reported by FDA: March 19, 2025
Distribution: Nationwide

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Drug Recall Ongoing Historical recordClass I

POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269

by ICU Medical, Inc.

Reason: Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
Recall initiated: February 13, 2025
Reported by FDA: March 19, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass I

POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266; Case (01)30309907075267

by ICU Medical, Inc.

Reason: Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
Recall initiated: February 13, 2025
Reported by FDA: March 19, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured by Adare Pharmaceuticals, Inc., Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409, UPC # 0 41167 0014 0

by Chattem Inc

Reason: CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Recall initiated: March 4, 2025
Reported by FDA: March 19, 2025
Distribution: Nationwide in the USA.

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Drug Recall Ongoing Historical recordClass II

Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.

by Aspen Biopharma Labs Pvt., Ltd.

Reason: CGMP Deviations
Recall initiated: February 7, 2025
Reported by FDA: March 19, 2025
Distribution: Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)

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Drug Recall Ongoing Historical recordClass II

Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle

by Aspen Biopharma Labs Pvt., Ltd.

Reason: CGMP Deviations
Recall initiated: February 7, 2025
Reported by FDA: March 19, 2025
Distribution: Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)

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Drug Recall Ongoing Historical recordClass II

Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.

by Aspen Biopharma Labs Pvt., Ltd.

Reason: CGMP Deviations
Recall initiated: February 7, 2025
Reported by FDA: March 19, 2025
Distribution: Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)

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Drug Recall Ongoing Historical recordClass II

Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.

by Aspen Biopharma Labs Pvt., Ltd.

Reason: CGMP Deviations
Recall initiated: February 7, 2025
Reported by FDA: March 19, 2025
Distribution: Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)

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Drug Recall Ongoing Historical recordClass II

Alprostadil Container Description: Amber color bottle

by Aspen Biopharma Labs Pvt., Ltd.

Reason: CGMP Deviations
Recall initiated: February 7, 2025
Reported by FDA: March 19, 2025
Distribution: Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)

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Drug Recall Ongoing Historical recordClass II

Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.

by Aspen Biopharma Labs Pvt., Ltd.

Reason: CGMP Deviations
Recall initiated: February 7, 2025
Reported by FDA: March 19, 2025
Distribution: Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)

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Drug Recall Ongoing Historical recordClass I

BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31.

by CareFusion 213, LLC

Reason: Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Recall initiated: February 14, 2025
Reported by FDA: March 19, 2025
Distribution: Nationwide and Canada

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Drug Recall Completed Historical recordClass III

Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd, Nagoya, 462-0024 Japan, Marketed by Kowa Pharmaceuticals: Kowa Pharmaceuticals America Inc., Montgomery, AL 36117 USA NDC 66869-404-90 HDPE Bottle, congregated into a shrink wrapped 6-pack further congregated into 24 6-packs in a cardboard case

by Kowa Pharmaceuticals America

Reason: Presence of foreign tablets/capsules
Recall initiated: February 24, 2025
Reported by FDA: March 19, 2025
Distribution: PA, OH, and TX

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Drug Recall Terminated Historical recordClass II

Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50

by Nephron Sterile Compounding Center LLC

Reason: Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Recall initiated: February 10, 2025
Reported by FDA: March 19, 2025
Distribution: US Nationwide.

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Drug Recall Ongoing Historical recordClass II

Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1839-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ

by Zydus Pharmaceuticals (USA) Inc

Reason: Failed Impurities/Degradation Specifications
Recall initiated: February 13, 2025
Reported by FDA: March 12, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1726-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ

by Zydus Pharmaceuticals (USA) Inc

Reason: Failed Impurities/Degradation Specifications
Recall initiated: February 13, 2025
Reported by FDA: March 12, 2025
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054051750.

by Safecor Health, LLC

Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Recall initiated: February 17, 2025
Reported by FDA: March 12, 2025
Distribution: Nationwide in the USA

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Data last updated: October 31, 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.