Public Health Trace

Get Alerts

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.

Filters

Drug Recall Completed Historical recordClass II

0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00

by B. Braun Medical Inc.

Reason: Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.
Recall initiated: February 10, 2023
Reported by FDA: March 1, 2023
Distribution: USA Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 200 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0160-5

by IBSA PHARMA INC

Reason: Subpotent Drug
Recall initiated: January 30, 2023
Reported by FDA: March 1, 2023
Distribution: Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 150 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0150-5

by IBSA PHARMA INC

Reason: Subpotent Drug
Recall initiated: January 30, 2023
Reported by FDA: March 1, 2023
Distribution: Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 137 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0145-5

by IBSA PHARMA INC

Reason: Subpotent Drug
Recall initiated: January 30, 2023
Reported by FDA: March 1, 2023
Distribution: Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 112 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0135-5

by IBSA PHARMA INC

Reason: Subpotent Drug
Recall initiated: January 30, 2023
Reported by FDA: March 1, 2023
Distribution: Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 88 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0125-5

by IBSA PHARMA INC

Reason: Subpotent Drug
Recall initiated: January 30, 2023
Reported by FDA: March 1, 2023
Distribution: Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 75 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0120-5

by IBSA PHARMA INC

Reason: Subpotent Drug
Recall initiated: January 30, 2023
Reported by FDA: March 1, 2023
Distribution: Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 62.5 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0117-5

by IBSA PHARMA INC

Reason: Subpotent Drug
Recall initiated: January 30, 2023
Reported by FDA: March 1, 2023
Distribution: Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 50 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0115-5

by IBSA PHARMA INC

Reason: Subpotent Drug
Recall initiated: January 30, 2023
Reported by FDA: March 1, 2023
Distribution: Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 44 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0113-5

by IBSA PHARMA INC

Reason: Subpotent Drug
Recall initiated: January 30, 2023
Reported by FDA: March 1, 2023
Distribution: Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 37.5 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0112-5

by IBSA PHARMA INC

Reason: Subpotent Drug
Recall initiated: January 30, 2023
Reported by FDA: March 1, 2023
Distribution: Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 25 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0110-5

by IBSA PHARMA INC

Reason: Subpotent Drug
Recall initiated: January 30, 2023
Reported by FDA: March 1, 2023
Distribution: Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 175 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0155-5

by IBSA PHARMA INC

Reason: Subpotent Drug
Recall initiated: January 30, 2023
Reported by FDA: March 1, 2023
Distribution: Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 125 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0140-5

by IBSA PHARMA INC

Reason: Subpotent Drug
Recall initiated: January 30, 2023
Reported by FDA: March 1, 2023
Distribution: Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 100 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0130-5

by IBSA PHARMA INC

Reason: Subpotent Drug
Recall initiated: January 30, 2023
Reported by FDA: March 1, 2023
Distribution: Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 13 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0105-5

by IBSA PHARMA INC

Reason: Subpotent Drug
Recall initiated: January 30, 2023
Reported by FDA: March 1, 2023
Distribution: Nationwide in the USA.

View recall →

Drug Recall Ongoing Historical recordClass II

Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500 090, INDIA; NDC 55111-525-01.

by Dr. Reddy's Laboratories, Inc.

Reason: Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
Recall initiated: February 8, 2023
Reported by FDA: March 1, 2023
Distribution: Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% First aid antiseptic, Benzocaine 20%) Topical analgesic, NET WT. 2.75 oz (78 g), Distributed by Advantice Health, LLC Cedar Knolls, NJ 07927, NDC# 16864-670-01

by Advantice Health, Llc

Reason: Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
Recall initiated: February 2, 2023
Reported by FDA: March 1, 2023
Distribution: Product was distributed via the internet, distributors and retailers nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

BuPROPion Hydrochloride Tablets, USP 75 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-340-01; NDC Blister Pack: 60687-340-11

by Amerisource Health Services LLC

Reason: Failed Impurities/Degradation Specifications
Recall initiated: December 27, 2022
Reported by FDA: February 22, 2023
Distribution: Nationwide within the USA

View recall →

Drug Recall Terminated Historical recordClass II

Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN 46268; Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 57665-101-41

by Leadiant Biosciences, Inc.

Reason: Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Recall initiated: February 3, 2023
Reported by FDA: February 22, 2023
Distribution: Nationwide USA

View recall →

Data last updated: November 3, 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.