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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

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

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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

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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

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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

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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

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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

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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

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Drug Recall Ongoing Historical recordClass II

0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10

by B. Braun Medical Inc

Reason: Presence of Particulate Matter
Recall initiated: March 31, 2025
Reported by FDA: April 16, 2025
Distribution: Product was distributed to 12 distributors who may have further distributed the product nationwide.

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Drug Recall Ongoing Historical recordClass II

Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-826-01

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations
Recall initiated: March 13, 2025
Reported by FDA: April 16, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-825-01.

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations
Recall initiated: March 13, 2025
Reported by FDA: April 16, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations
Recall initiated: March 13, 2025
Reported by FDA: April 16, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-559-01

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations
Recall initiated: March 13, 2025
Reported by FDA: April 16, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations
Recall initiated: March 13, 2025
Reported by FDA: April 16, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Product of India

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations
Recall initiated: March 13, 2025
Reported by FDA: April 16, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-179-01

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations
Recall initiated: March 13, 2025
Reported by FDA: April 16, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.

by Glenmark Pharmaceuticals Inc., USA

Reason: CGMP Deviations
Recall initiated: March 13, 2025
Reported by FDA: April 16, 2025
Distribution: U.S. Nationwide

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Data last updated: September 7, 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.