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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

C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder 115 South 40th Ave, Suite A Hattiesburg, MS 39402

by Pharmacy Plus, Inc. dba Vital Care Compounder

Reason: Lack of assurance of sterility.
Recall initiated: April 13, 2023
Reported by FDA: April 26, 2023
Distribution: MS only

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Drug Recall Ongoing Historical recordClass II

Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle, OTC, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, CVS Product # 999532, UPC 0 50428 36475 8.

by Pharma Nobis LLC

Reason: CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Recall initiated: April 6, 2023
Reported by FDA: April 26, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (10 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-504-01; NDC Unit Dose: 60687-504-11, barcode (01) 003 60687 504 11 7.

by Amerisource Health Services LLC

Reason: Failed Dissolution Specifications: Out of specification dissolution results above specified values.
Recall initiated: March 16, 2023
Reported by FDA: April 26, 2023
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass III

Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufactured for: Focus Health Group, 5802 Kingston Pike, Knoxville, TN 37919. Incorrect NDC (kit): 24357-011-13

by Focus Health Group Inc

Reason: Labeling; Incorrect NDC number on outer carton of product.
Recall initiated: March 16, 2023
Reported by FDA: April 19, 2023
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass III

MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc., Boulder, CO 80301. NDC: 70255-010-02

by Pfizer Inc.

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
Recall initiated: March 8, 2023
Reported by FDA: April 19, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each Syringe supplied in individually labeled poly envelopes (primary packaging). Repackaged by Pine Pharmaceuticals, Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150, Office Use Only, Not for Resale. Secondary packaging consists of a coated cardboard box, with order-specific label indicating lot number housed within order/container. NDC # 69194-0458-1

by Pine Pharmaceuticals, LLC

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
Recall initiated: March 27, 2023
Reported by FDA: April 19, 2023
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ, 08854, By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar- 509 301, India NDC 31722-713-10

by Hetero USA Inc

Reason: CGMP Deviations: Discoloration
Recall initiated: March 14, 2023
Reported by FDA: April 19, 2023
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass III

Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40); packaged in 10 x 4 mL Single-dose Fliptop Vials per carton (NDC 47335-615-44); Rx only, Manufactured by: Gland Pharma Limited, Hyderabad-502307 India; Distributed by: Sun Phamaceutical Industries, Inc., Cranbury, NJ 08512.

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
Recall initiated: March 29, 2023
Reported by FDA: April 19, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutaneous Use Only, Rx Only, Sterile, Manufactured by: Intas Pharmaceuticals Limited Pharmaz Ahnedabad 382 213, INDIA, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-533-08.

by ACCORD HEALTHCARE, INC.

Reason: Sub-potent drug: assay test result below specifications at 9-month timepoint.
Recall initiated: March 29, 2023
Reported by FDA: April 12, 2023
Distribution: Nationwide in the USA.

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Drug Recall Ongoing Historical recordClass II

Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9

by Preferred Pharmaceuticals, Inc.

Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Recall initiated: March 23, 2023
Reported by FDA: April 12, 2023
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-8153-7

by Preferred Pharmaceuticals, Inc.

Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Recall initiated: March 23, 2023
Reported by FDA: April 12, 2023
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c) 30-count bottle (NDC 68788-9868-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.

by Preferred Pharmaceuticals, Inc.

Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Recall initiated: March 23, 2023
Reported by FDA: April 12, 2023
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-9869-6); c) 30-count bottle (NDC 68788-9869-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.

by Preferred Pharmaceuticals, Inc.

Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Recall initiated: March 23, 2023
Reported by FDA: April 12, 2023
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9429-9

by Preferred Pharmaceuticals, Inc.

Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Recall initiated: March 23, 2023
Reported by FDA: April 12, 2023
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9747-9

by Preferred Pharmaceuticals, Inc.

Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Recall initiated: March 23, 2023
Reported by FDA: April 12, 2023
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8215-9

by Preferred Pharmaceuticals, Inc.

Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Recall initiated: March 23, 2023
Reported by FDA: April 12, 2023
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7971-3

by Preferred Pharmaceuticals, Inc.

Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Recall initiated: March 23, 2023
Reported by FDA: April 12, 2023
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-7086-3); b) 90-count bottle (NDC 68788-7086-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.

by Preferred Pharmaceuticals, Inc.

Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Recall initiated: March 23, 2023
Reported by FDA: April 12, 2023
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.

by Preferred Pharmaceuticals, Inc.

Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Recall initiated: March 23, 2023
Reported by FDA: April 12, 2023
Distribution: USA Nationwide

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Drug Recall Ongoing Historical recordClass II

Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8095-9

by Preferred Pharmaceuticals, Inc.

Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Recall initiated: March 23, 2023
Reported by FDA: April 12, 2023
Distribution: USA Nationwide

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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.