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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 Ongoing Historical recordClass II

Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.

by Sagent Pharmaceuticals

Reason: Lack of Assurance of Sterility
Recall initiated: July 11, 2023
Reported by FDA: August 2, 2023
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.

by Sagent Pharmaceuticals

Reason: Lack of Assurance of Sterility
Recall initiated: July 11, 2023
Reported by FDA: August 2, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in India, NDC 72657-113-20.

by Glenmark Therapeutics, Inc.

Reason: Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Recall initiated: May 1, 2023
Reported by FDA: July 26, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-702-01.

by SterRx, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: July 7, 2023
Reported by FDA: July 26, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per carton, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-602-01.

by SterRx, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: July 7, 2023
Reported by FDA: July 26, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-577-01.

by SterRx, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: July 7, 2023
Reported by FDA: July 26, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-552-01.

by SterRx, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: July 7, 2023
Reported by FDA: July 26, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 units per case, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.

by SterRx, LLC

Reason: Lack of Assurance of Sterility
Recall initiated: July 7, 2023
Reported by FDA: July 26, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC 71546-310-50;

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

ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-090-05

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

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.

View recall →

Data last updated: November 2, 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.