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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 II

PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-450-25;

by New England Life Care, Inc. dba Advanced Compounding Solutions

Reason: CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Recall initiated: July 10, 2023
Reported by FDA: July 26, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042; NDC: 71546-083-10

by New England Life Care, Inc. dba Advanced Compounding Solutions

Reason: CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Recall initiated: July 10, 2023
Reported by FDA: July 26, 2023
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-476-30.

by Ascend Laboratories, LLC

Reason: Failed Dissolution Specifications
Recall initiated: July 11, 2023
Reported by FDA: July 26, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC# 62756-232-55) and b) 15 mL bottle (NDC # 62756-232-56), Rx only, Distributed by: Sun Pharmaceutical Ind., Inc., NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Ltd., India.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Recall initiated: July 5, 2023
Reported by FDA: July 26, 2023
Distribution: USA nationwide.

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Drug Recall Ongoing Historical recordClass II

Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10

by Dr Reddy's Laboratories Limited

Reason: Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Recall initiated: June 21, 2023
Reported by FDA: July 26, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass I

Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ, 07059, NDC 69097-142-60

by Cipla USA, Inc.

Reason: Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
Recall initiated: June 27, 2023
Reported by FDA: July 19, 2023
Distribution: Nationwide in the US

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Drug Recall Ongoing Historical recordClass II

Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.

by Global Pharma Healthcare Private Limited

Reason: CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
Recall initiated: January 30, 2023
Reported by FDA: July 19, 2023
Distribution: Product was distributed to two distributors who further distributed Nationwide in the USA.

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Drug Recall Ongoing Historical recordClass I

Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.

by Global Pharma Healthcare Private Limited

Reason: Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Recall initiated: January 30, 2023
Reported by FDA: July 19, 2023
Distribution: Product was distributed to two distributors who further distributed Nationwide in the USA.

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Drug Recall Ongoing Historical recordClass II

Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.

by Global Pharma Healthcare Private Limited

Reason: CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
Recall initiated: January 30, 2023
Reported by FDA: July 19, 2023
Distribution: Product was distributed to two distributors who further distributed Nationwide in the USA.

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Drug Recall Ongoing Historical recordClass I

Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.

by Global Pharma Healthcare Private Limited

Reason: Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Recall initiated: January 30, 2023
Reported by FDA: July 19, 2023
Distribution: Product was distributed to two distributors who further distributed Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-275-67.

by ACCORD HEALTHCARE, INC.

Reason: Presence of Particulate Matter: Particulate matter identified as fiber.
Recall initiated: July 3, 2023
Reported by FDA: July 19, 2023
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-512-43.

by ACCORD HEALTHCARE, INC.

Reason: Presence of Particulate Matter: Particulate matter identified as fiber.
Recall initiated: July 3, 2023
Reported by FDA: July 19, 2023
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00

by B. Braun Medical Inc.

Reason: Lack of assurance of sterility: bags have the potential to leak.
Recall initiated: July 5, 2023
Reported by FDA: July 19, 2023
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution, Produced and Distributed by Big Machine Distillery 1800 Abernathy Road Lynnville, TN 38472 a) 50 mL UPC 8 59105 00452 5; b) 100 mL UPC 8 59105 00453 2; c) 375 mL; d) 1/2 gallon; e) 1 gallon; f) 5 gallon; g) 55 gallon; i) Indianapolis Motor Speedway 50 mL UPC 8 59105 00452 5; j) Indianapolis Motor Speedway 375 mL UPC 8 59105 00454 9; k) Indianapolis Motor Speedway 1 gallon UPC 8 59105 00451 7; l) The Contributor 50 mL; m) Tony Kanaan Last Lap 100 mL; n) Tony Kanaan Last Lap 375 mL; o) Trexis Insurance 50 mL; p) Team Penske 50 mL; q) Middle Tennessee State University Lightning 50 mL.

by Tenn South Distillery LLC dba Big Machine Distillery

Reason: CGMP Deviation: impurities exceed allowable limits.
Recall initiated: July 10, 2023
Reported by FDA: July 19, 2023
Distribution: TN

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Drug Recall Terminated Historical recordClass II

Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India. NDC#: 62756-200-83

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Recall initiated: July 10, 2023
Reported by FDA: July 19, 2023
Distribution: Distributed nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28

by Teva Pharmaceuticals USA Inc

Reason: Failed Moisture Limits: Water (moisture) content above the approved product specifications.
Recall initiated: July 5, 2023
Reported by FDA: July 19, 2023
Distribution: Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 36800-691-39), b)45-count cartons (NDC 36800-691-95), and 90-count cartons (NDC 36800-691-75), Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007.

by L. Perrigo Company

Reason: Failed Impurities/Degradation Specifications
Recall initiated: February 9, 2023
Reported by FDA: July 19, 2023
Distribution: Nationwide within the USA

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Drug Recall Terminated Historical recordClass II

Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine, 90-count cartons, Distributed by: Thirty Madison, Inc., New York, NY 10001. NDC 45 tablets: 80159-112-03

by L. Perrigo Company

Reason: Failed Impurities/Degradation Specifications
Recall initiated: February 9, 2023
Reported by FDA: July 19, 2023
Distribution: Nationwide within the USA

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Drug Recall Terminated Historical recordClass II

allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 11673-617-22), b)30-count cartons (NDC 11673-617-39), c)70-count cartons (NDC 11673-617-01), and d)150-count cartons (11673-617-47), Distributed by: Target Corporation, Minneapolis, MN 55403.

by L. Perrigo Company

Reason: Failed Impurities/Degradation Specifications
Recall initiated: February 9, 2023
Reported by FDA: July 19, 2023
Distribution: Nationwide within the USA

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Drug Recall Terminated Historical recordClass II

allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39); and b) 45-count cartons (NDC 56062-847-95), Distributed by: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811.

by L. Perrigo Company

Reason: Failed Impurities/Degradation Specifications
Recall initiated: February 9, 2023
Reported by FDA: July 19, 2023
Distribution: Nationwide within the USA

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Data last updated: September 10, 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.