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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 3,681–3,700 of 17,937 drug recalls

Drug Recall Ongoing Historical recordClass II

Dexpanthenol Preservative Free 250mg/mL, 2mL-vial, Room Temperature, Tailor Made Compounding

by TMC Acquisition LLC dba Tailor Made Compounding

Reason
Lack of Assurance of Sterility
Recall initiated
March 7, 2022
Reported by FDA
July 20, 2022
Distribution
Nationwide USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Dexpanthenol 250mg/mL, 30mL-vial, Room Temperature, Tailor Made Compounding

by TMC Acquisition LLC dba Tailor Made Compounding

Reason
Lack of Assurance of Sterility
Recall initiated
March 7, 2022
Reported by FDA
July 20, 2022
Distribution
Nationwide USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Calcium Chloride Preservative Free, 100mg/mL, a) 5 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding

by TMC Acquisition LLC dba Tailor Made Compounding

Reason
Lack of Assurance of Sterility
Recall initiated
March 7, 2022
Reported by FDA
July 20, 2022
Distribution
Nationwide USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Biotin 5mg/mL, 5mL-vial, Refrigerate, Tailor Made Compounding

by TMC Acquisition LLC dba Tailor Made Compounding

Reason
Lack of Assurance of Sterility
Recall initiated
March 7, 2022
Reported by FDA
July 20, 2022
Distribution
Nationwide USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

BCAAs (Leucine/Iso-Leucine/Valine) 10mg/10mg/5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding

by TMC Acquisition LLC dba Tailor Made Compounding

Reason
Lack of Assurance of Sterility
Recall initiated
March 7, 2022
Reported by FDA
July 20, 2022
Distribution
Nationwide USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Ascorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 ml-vial, Refrigerate, Tailor Made Compounding

by TMC Acquisition LLC dba Tailor Made Compounding

Reason
Lack of Assurance of Sterility
Recall initiated
March 7, 2022
Reported by FDA
July 20, 2022
Distribution
Nationwide USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Anastrozole/Testosterone Cypionate/Propionate 1mg/160mg/40mg/mL, 10 mL-vial, Room Temperature, Tailor Made Compounding

by TMC Acquisition LLC dba Tailor Made Compounding

Reason
Lack of Assurance of Sterility
Recall initiated
March 7, 2022
Reported by FDA
July 20, 2022
Distribution
Nationwide USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL, 3mL-vial, Refrigerate, Tailor Made Compounding

by TMC Acquisition LLC dba Tailor Made Compounding

Reason
Lack of Assurance of Sterility
Recall initiated
March 7, 2022
Reported by FDA
July 20, 2022
Distribution
Nationwide USA and Puerto Rico

View recall →

Drug Recall Ongoing Historical recordClass II

Alpha Lipoic Acid 25mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding

by TMC Acquisition LLC dba Tailor Made Compounding

Reason
Lack of Assurance of Sterility
Recall initiated
March 7, 2022
Reported by FDA
July 20, 2022
Distribution
Nationwide USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Hydrogen Peroxide Topical Solution, USP, 32 fl. oz. (1 QT) 946 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 59779-871-45, UPC 0-50428-40950-3

by Vi-Jon, LLC

Reason
Labeling: Label Mix-Up-The primary label on the front of the bottles have Hydrogen Peroxide affixed to the front and back of the containers. However, the product inside the bottle is 70% Isopropyl Alcohol.
Recall initiated
June 24, 2022
Reported by FDA
July 20, 2022
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-dose vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol- Baroda Highway, Halol-Baroda, Highway, Halol- 389 350, Gujarat, India, NDC 62756-015-40.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
cGMP - Water leakage
Recall initiated
June 21, 2022
Reported by FDA
July 20, 2022
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30 glass vials per carton, Rx Only, Manufactured for Jubilant Draximage Inc. Kirkland, Canada, NDC 65174-270-30.

by Jubilant Draximage Inc

Reason
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Recall initiated
June 16, 2022
Reported by FDA
July 20, 2022
Distribution
Product was distributed to retailers nationwide.

View recall →

Drug Recall Terminated Historical recordClass I

Morphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., NJ; Relabeled by: Bryant Ranch Prepack, Inc, CA, NDC 63629-1089-01

by Bryant Ranch Prepack, Inc.

Reason
Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
Recall initiated
June 17, 2022
Reported by FDA
July 20, 2022
Distribution
Distributed to one wholesaler in AL for further distribution in the US.

View recall →

Drug Recall Terminated Historical recordClass I

Morphine Sulfate extended-Release Tablets, USP; 30 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., New Brunswick NJ 08901 USA; Relabeled by: Bryant Ranch Prepack, Inc., Burbank, CA, 91504 USA, NDC: 63629-1088-01.

by Bryant Ranch Prepack, Inc.

Reason
Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
Recall initiated
June 17, 2022
Reported by FDA
July 20, 2022
Distribution
Distributed to one wholesaler in AL for further distribution in the US.

View recall →

Drug Recall Terminated Historical recordClass II

Estriol 1mg/gm, Vaginal Cream, 30 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085

by Wedgewood Village Pharmacy, LLC

Reason
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Recall initiated
June 10, 2022
Reported by FDA
July 13, 2022
Distribution
Products were distributed nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Boric Acid 600 mg per suppository, 14 Vaginal Suppositories per box, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085

by Wedgewood Village Pharmacy, LLC

Reason
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Recall initiated
June 10, 2022
Reported by FDA
July 13, 2022
Distribution
Products were distributed nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Estriol 1mg/gm, Vaginal Cream, 60 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085

by Wedgewood Village Pharmacy, LLC

Reason
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Recall initiated
June 10, 2022
Reported by FDA
July 13, 2022
Distribution
Products were distributed nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Boric Acid 600 mg capsules, 14 capsules per box, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085

by Wedgewood Village Pharmacy, LLC

Reason
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Recall initiated
June 10, 2022
Reported by FDA
July 13, 2022
Distribution
Products were distributed nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Doxycycline (as Calcium) (equivalent to 50mg/5mL), 10 mg/ml, 60 ml suspension bottles, Peppermint, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Dr, Ste 200, Swedesboro, NJ 08085

by Wedgewood Village Pharmacy, LLC

Reason
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Recall initiated
June 10, 2022
Reported by FDA
July 13, 2022
Distribution
Products were distributed nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Bethanechol Chloride 1mg/ml, 80 ml Suspension bottles Banana/Strawberry, Qty:1, Wedgewood Village Pharmacy LLC, 405 Heron Dr. Ste 200, Swedesboro, NJ 08085

by Wedgewood Village Pharmacy, LLC

Reason
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Recall initiated
June 10, 2022
Reported by FDA
July 13, 2022
Distribution
Products were distributed nationwide in the USA.

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.