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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 241–260 of 17,898 drug recalls

Drug Recall Ongoing 2026 recordClass II

Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.

by Breckenridge Pharmaceutical, Inc.

Reason
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Recall initiated
April 21, 2026
Reported by FDA
May 13, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.

by JB Chemicals and Pharmaceuticals Ltd

Reason
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Recall initiated
April 23, 2026
Reported by FDA
May 13, 2026
Distribution
Nationwide in the USA

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Drug Recall Ongoing 2026 recordClass II

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1¿ 19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21.

by Teva Pharmaceuticals USA, Inc

Reason
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Recall initiated
April 24, 2026
Reported by FDA
May 13, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becton Dickinson and Co. NDC 54365-014-41

by CareFusion 213, LLC

Reason
Lack of assurance of Sterility: potential product contamination
Recall initiated
April 22, 2026
Reported by FDA
May 13, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42.

by CareFusion 213, LLC

Reason
Lack of assurance of Sterility: potential product contamination
Recall initiated
April 22, 2026
Reported by FDA
May 13, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.

by Ajanta Pharma Ltd.

Reason
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Recall initiated
April 29, 2026
Reported by FDA
May 13, 2026
Distribution
Nationwide within U.S

View recall →

Drug Recall Ongoing 2026 recordClass II

Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03

by Ajanta Pharma Ltd.

Reason
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Recall initiated
April 29, 2026
Reported by FDA
May 13, 2026
Distribution
Nationwide within U.S

View recall →

Drug Recall Ongoing 2026 recordClass II

Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India

by Ajanta Pharma Ltd.

Reason
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Recall initiated
April 29, 2026
Reported by FDA
May 13, 2026
Distribution
Nationwide within U.S

View recall →

Drug Recall Ongoing 2026 recordClass II

DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.

by Fresenius Medical Care Holdings, Inc.

Reason
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Recall initiated
April 6, 2026
Reported by FDA
May 13, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.

by Fresenius Medical Care Holdings, Inc.

Reason
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Recall initiated
April 6, 2026
Reported by FDA
May 13, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass III

busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.

by Unichem Pharmaceuticals USA Inc.

Reason
Subpotent drug
Recall initiated
April 13, 2026
Reported by FDA
May 13, 2026
Distribution
USA Nationwide

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Drug Recall Ongoing 2026 recordClass II

Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59.

by Hikma Pharmaceuticals USA INC

Reason
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Recall initiated
April 7, 2026
Reported by FDA
May 6, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass III

Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by: CVS PHarmacy, INc., One CVS Drive, Woonsocket, RI 02895. NDC 59898-950

by Water-Jel Technologies, LLC

Reason
Failed PH Specifications
Recall initiated
April 7, 2026
Reported by FDA
May 6, 2026
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing 2026 recordClass II

fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.

by Wells Pharma of Houston LLC

Reason
cGMP deviations.
Recall initiated
April 1, 2026
Reported by FDA
May 6, 2026
Distribution
U.S. Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.

by Wells Pharma of Houston LLC

Reason
cGMP deviations.
Recall initiated
April 1, 2026
Reported by FDA
May 6, 2026
Distribution
U.S. Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.

by Wells Pharma of Houston LLC

Reason
cGMP deviations.
Recall initiated
April 1, 2026
Reported by FDA
May 6, 2026
Distribution
U.S. Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.

by Wells Pharma of Houston LLC

Reason
cGMP deviations.
Recall initiated
April 1, 2026
Reported by FDA
May 6, 2026
Distribution
U.S. Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.

by Wells Pharma of Houston LLC

Reason
cGMP deviations.
Recall initiated
April 1, 2026
Reported by FDA
May 6, 2026
Distribution
U.S. Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.

by Wells Pharma of Houston LLC

Reason
cGMP deviations.
Recall initiated
April 1, 2026
Reported by FDA
May 6, 2026
Distribution
U.S. Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03

by Wells Pharma of Houston LLC

Reason
cGMP deviations.
Recall initiated
April 1, 2026
Reported by FDA
May 6, 2026
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.