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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 1,221–1,240 of 18,047 drug recalls

Drug Recall Terminated Historical recordClass II

Kingskin, Elimina Las Verrugas, For the removal of common warts, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-409-15

by Pharmadel, LLC

Reason
cGMP deviations
Recall initiated
April 15, 2025
Reported by FDA
April 30, 2025
Distribution
DE

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Drug Recall Terminated Historical recordClass II

DoloDent Maximum Strength Toothache Drops, Homeopathic Oral Drops, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-400-15

by Pharmadel, LLC

Reason
cGMP deviations
Recall initiated
April 15, 2025
Reported by FDA
April 30, 2025
Distribution
DE

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Drug Recall Ongoing Historical recordClass II

Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2%, Net Wt. 0.7 oz (20g) tubes, Manufactured by: Apipharma d.o.o, Croatia, Distributed by: Apipharma, LLC, Tempe, AZ UPC 3 858882 103534 and UPC 3 858882 101318

by Apipharma

Reason
CGMP Deviations
Recall initiated
April 9, 2025
Reported by FDA
April 30, 2025
Distribution
AZ

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Drug Recall Ongoing Historical recordClass II

Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11

by Denver Solutions, LLC DBA Leiters Health

Reason
Lack of Assurance of Sterility: Leaking/damaged syringes.
Recall initiated
March 31, 2025
Reported by FDA
April 30, 2025
Distribution
Nationwide in the U.S.A

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Drug Recall Ongoing Historical recordClass II

Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-581-48.

by Amerisource Health Services LLC

Reason
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Recall initiated
April 2, 2025
Reported by FDA
April 30, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for BluePoint Laboratories, NDC 68001-581-41.

by Amerisource Health Services LLC

Reason
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Recall initiated
April 2, 2025
Reported by FDA
April 30, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-580-41.

by Amerisource Health Services LLC

Reason
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Recall initiated
April 2, 2025
Reported by FDA
April 30, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Recall initiated
April 14, 2025
Reported by FDA
April 23, 2025
Distribution
Nationwide USA

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Drug Recall Ongoing Historical recordClass I

Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, Hyderabad, - 500 043 INDIA, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-636-52

by Dr. Reddy's Laboratories, Inc.

Reason
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
Recall initiated
March 13, 2025
Reported by FDA
April 23, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.

by Direct Rx

Reason
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Recall initiated
January 31, 2025
Reported by FDA
April 23, 2025
Distribution
Physicians and medical facilities in 5 states: AL, CA, FL, GA, ID

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Drug Recall Ongoing Historical recordClass II

Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, Manufactured by: Eugia Specialties Limited, Telangana State, India, NDC 55150-277-01

by Eugia US LLC

Reason
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Recall initiated
April 10, 2025
Reported by FDA
April 23, 2025
Distribution
Nationwide USA

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Drug Recall Ongoing Historical recordClass II

Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409-0219, USA, UPC 0 41167 00670 2

by Chattem Inc

Reason
CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
Recall initiated
March 26, 2025
Reported by FDA
April 23, 2025
Distribution
Nationwide.

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Drug Recall Ongoing Historical recordClass II

chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd., Baddi, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1129-1

by Zydus Pharmaceuticals (USA) Inc

Reason
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Recall initiated
April 3, 2025
Reported by FDA
April 16, 2025
Distribution
Nationwide within U.S - MS, AL, TN, VT, OH, ND, MN, WI, SC, AR, FL, IN, LA, NJ, AZ, TX, KY and PA

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Drug Recall Ongoing Historical recordClass II

Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%), Packaged as a) 6 fl. oz. (177.4 mL), UPC 7 35786 01528 2; b) 0.33 OZ (9.45g), UPC 8 42944 10223 1; Distributed by Alchemee, LLC, Santa Monica, CA 90401,

by Alchemee, LLC

Reason
Chemical contamination: Presence of benzene
Recall initiated
March 12, 2025
Reported by FDA
April 16, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%), 0.33 oz. (9.45 g), Distributed by Alchemee LLC, Santa Monica, CA 90401, Made in the USA, UPC 7 35786 01921 1, UPC 8 42944 10223 1, and also packaged as a twin pack UPC 8 42944 10241 5,

by Alchemee, LLC

Reason
Chemical contamination: Presence of benzene
Recall initiated
March 12, 2025
Reported by FDA
April 16, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10

by Somerset Therapeutics Private Limited

Reason
Lack of Assurance of Sterility: Media fill with bacterial contamination
Recall initiated
March 21, 2025
Reported by FDA
April 16, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5x1 mL cartons)

by Somerset Therapeutics Private Limited

Reason
Lack of Assurance of Sterility: Media fill with bacterial contamination
Recall initiated
March 21, 2025
Reported by FDA
April 16, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41

by Somerset Therapeutics Private Limited

Reason
Lack of Assurance of Sterility: Media fill with bacterial contamination
Recall initiated
March 21, 2025
Reported by FDA
April 16, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton)

by Somerset Therapeutics Private Limited

Reason
Lack of Assurance of Sterility: Media fill with bacterial contamination
Recall initiated
March 21, 2025
Reported by FDA
April 16, 2025
Distribution
U.S. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-101-25 (immediate carton) and 70069-101-05 (5x10 mL carton)

by Somerset Therapeutics Private Limited

Reason
Lack of Assurance of Sterility: Media fill with bacterial contamination
Recall initiated
March 21, 2025
Reported by FDA
April 16, 2025
Distribution
U.S. Nationwide

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.

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