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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 Terminated Historical recordClass III

Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets per box, UPC 343598823355, b) 20 tablets per box, UPC 343598823140, c) 30 tablets per box, UPC 343598823317, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Made in India.

by Dr. Reddy's Laboratories, Inc.

Reason: Failed Dissolution Specifications
Recall initiated: January 4, 2022
Reported by FDA: January 26, 2022
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended-Release Tablets USP, 20 tablets per box, NDC 30142-611-14, Distributed by the Kroger Co., Cincinnati, Ohio, 45202, Made in India.

by Dr. Reddy's Laboratories, Inc.

Reason: Failed Dissolution Specifications
Recall initiated: January 4, 2022
Reported by FDA: January 26, 2022
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg, Extended Release Tablets USP, 20 Extended-Release Tablets per box, UPC 011822738873, Distributed by Rite Aid, 30 United Lane, Camp Hill, PA 17011, Made in India.

by Dr. Reddy's Laboratories, Inc.

Reason: Failed Dissolution Specifications
Recall initiated: January 4, 2022
Reported by FDA: January 26, 2022
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP, 30 Tablets per box, NDC 0536-1242-07, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI, 49152, Made in India.

by Dr. Reddy's Laboratories, Inc.

Reason: Failed Dissolution Specifications
Recall initiated: January 4, 2022
Reported by FDA: January 26, 2022
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 0363-1606-20, b) 30 Extended Release Tablets per box, NDC 0363-1606-30, Distributed by: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015, Made in India.

by Dr. Reddy's Laboratories, Inc.

Reason: Failed Dissolution Specifications
Recall initiated: January 4, 2022
Reported by FDA: January 26, 2022
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass I

SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC 50262-731-24.

by Lohxa, LLC

Reason: Microbial Contamination of Non-Sterile Product
Recall initiated: December 21, 2021
Reported by FDA: January 26, 2022
Distribution: Product was distributed to one wholesale who further distributed the product nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408.

by Ingenus Pharmaceuticals Llc

Reason: CGMP Deviations
Recall initiated: January 10, 2022
Reported by FDA: January 26, 2022
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropper bottles (NDC 0591-2127-12), Rx Only, Manufactured in India By: Indoco Remedies Limited Verna, Goa - 403722, India, Manufactured For: Teva Pharmaceuticals USA, Inc. Parsippany, NJ

by Teva Pharmaceuticals USA

Reason: Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not dispensing.
Recall initiated: December 8, 2021
Reported by FDA: January 26, 2022
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit forming, Preservative Free, Manufactured by Akorn, Inc. Lake Forest, IL 60045, NDC 17478-0050-02.

by Akorn, Inc.

Reason: Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
Recall initiated: January 5, 2022
Reported by FDA: January 19, 2022
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass I

Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC 51672-1259-3

by Taro Pharmaceuticals U.S.A., Inc.

Reason: Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Recall initiated: December 15, 2021
Reported by FDA: January 19, 2022
Distribution: Two distributors in UT and LA who could have further distributed to the retail level nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, Manufactured by Perrigo, Yeruham, Israel; Distributed by Perrigo, Allegan, MI 49010, NDC 45802-210-02

by Padagis US LLC

Reason: Defective Delivery System
Recall initiated: December 27, 2021
Reported by FDA: January 19, 2022
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass II

Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-03.

by Teva Pharmaceuticals USA

Reason: Lack of Assurance of Sterility
Recall initiated: December 31, 2021
Reported by FDA: January 19, 2022
Distribution: Methylprednisolone, TN Norepinephrine BItartrate - MS, OH

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Drug Recall Terminated Historical recordClass II

MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 16714-090-01, packaged in cartons.

by Teva Pharmaceuticals USA

Reason: Lack of Assurance of Sterility
Recall initiated: December 31, 2021
Reported by FDA: January 19, 2022
Distribution: Methylprednisolone, TN Norepinephrine BItartrate - MS, OH

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Drug Recall Terminated Historical recordClass II

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1

by Exela Pharma Sciences LLC

Reason: Lack of Assurance of Sterility
Recall initiated: January 11, 2022
Reported by FDA: January 19, 2022
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass III

Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 --- NDC 50383-961-34

by Akorn, Inc.

Reason: Labeling: Missing Label
Recall initiated: December 3, 2021
Reported by FDA: January 19, 2022
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass III

Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 -- NDC 50383-965-30

by Akorn, Inc.

Reason: Labeling: Missing Label
Recall initiated: December 3, 2021
Reported by FDA: January 19, 2022
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass II

Metformin 750 mg Extended Release NDC # 70518-2920-00

by RemedyRePack Inc.

Reason: CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Recall initiated: December 30, 2021
Reported by FDA: January 19, 2022
Distribution: Product was distributed to one direct account in PA.

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Drug Recall Terminated Historical recordClass II

Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd. Bharuch-392130, India Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920.

by Torrent Pharma Inc.

Reason: Failed Dissolution Specifications
Recall initiated: December 2, 2021
Reported by FDA: January 19, 2022
Distribution: Nationwide USA

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Drug Recall Ongoing Historical recordClass II

The Natural Dentist Healthy Balance Peppermint Sage, Menthol 0.12%, 16.9 FL OZ (500 mL) bottles, Manufactured for Revive Personal Products Company, Madison, NJ 07940, UPC 7 14132 00071 4

by Revive Personal Products Company

Reason: Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8
Recall initiated: September 28, 2021
Reported by FDA: January 19, 2022
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609; Manufactured by: Rubicon Research Prvate Limited Ambernath, Dist. Thane, 421506 India. NDC 52817-360-00

by Rubicon Research Private Limited

Reason: Complaint received of foreign matter (metal) embedded in tablet.
Recall initiated: December 31, 2021
Reported by FDA: January 19, 2022
Distribution: Product was distributed to one distributor who may have distributed the product further nationwide.

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Data last updated: September 13, 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.