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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 III

Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155

by Denison Pharmaceuticals, LLC

Reason: Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Recall initiated: September 25, 2024
Reported by FDA: November 13, 2024
Distribution: Product was distributed to two accounts that may have distributed the product further to the Retail Level.

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Drug Recall Ongoing Historical recordClass II

Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Recall initiated: October 10, 2024
Reported by FDA: November 6, 2024
Distribution: Nationwide in the USA and PR

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Drug Recall Ongoing Historical recordClass II

Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-441-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Recall initiated: October 10, 2024
Reported by FDA: November 6, 2024
Distribution: Nationwide in the USA and PR

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Drug Recall Ongoing Historical recordClass II

Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.

by ACCORD HEALTHCARE, INC.

Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Recall initiated: October 10, 2024
Reported by FDA: November 6, 2024
Distribution: Nationwide in the USA and PR

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Drug Recall Terminated Historical recordClass II

Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24

by BLI International, Inc.

Reason: Superpotent Drug: Stability failure for assay at 6 months test time-point.
Recall initiated: October 21, 2024
Reported by FDA: November 6, 2024
Distribution: Product was shipped to two private label customers ( OH & MO) as a final packaged product.

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Drug Recall Ongoing Historical recordClass II

Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.

by Dr. Reddy's Laboratories, Inc.

Reason: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Recall initiated: October 9, 2024
Reported by FDA: November 6, 2024
Distribution: USA Nationwide.

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Drug Recall Ongoing Historical recordClass II

Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.

by Dr. Reddy's Laboratories, Inc.

Reason: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Recall initiated: October 9, 2024
Reported by FDA: November 6, 2024
Distribution: USA Nationwide.

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Drug Recall Ongoing Historical recordClass II

Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.

by Dr. Reddy's Laboratories, Inc.

Reason: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Recall initiated: October 9, 2024
Reported by FDA: November 6, 2024
Distribution: USA Nationwide.

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Drug Recall Ongoing Historical recordClass II

OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., Fairfield, NJ 07004, NDC 71399-0039-06.

by Akron Pharma, Inc.

Reason: CGMP Deviations
Recall initiated: October 15, 2024
Reported by FDA: October 30, 2024
Distribution: Nationwide in the US

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Drug Recall Ongoing Historical recordClass II

AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,

by C & A Naturistics

Reason: Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
Recall initiated: October 8, 2024
Reported by FDA: October 30, 2024
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56

by Fresenius Kabi Compounding, LLC

Reason: cGMP violations
Recall initiated: September 25, 2024
Reported by FDA: October 30, 2024
Distribution: Product was distributed to 125 direct accounts nationwide.

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Drug Recall Terminated Historical recordClass II

EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58

by Fresenius Kabi Compounding, LLC

Reason: cGMP violations
Recall initiated: September 25, 2024
Reported by FDA: October 30, 2024
Distribution: Product was distributed to 125 direct accounts nationwide.

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Drug Recall Terminated Historical recordClass II

Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59

by Fresenius Kabi Compounding, LLC

Reason: cGMP violations
Recall initiated: September 25, 2024
Reported by FDA: October 30, 2024
Distribution: Product was distributed to 125 direct accounts nationwide.

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Drug Recall Terminated Historical recordClass II

NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58

by Fresenius Kabi Compounding, LLC

Reason: cGMP violations
Recall initiated: September 25, 2024
Reported by FDA: October 30, 2024
Distribution: Product was distributed to 125 direct accounts nationwide.

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Drug Recall Terminated Historical recordClass II

NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58

by Fresenius Kabi Compounding, LLC

Reason: cGMP violations
Recall initiated: September 25, 2024
Reported by FDA: October 30, 2024
Distribution: Product was distributed to 125 direct accounts nationwide.

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Drug Recall Terminated Historical recordClass II

Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58

by Fresenius Kabi Compounding, LLC

Reason: cGMP violations
Recall initiated: September 25, 2024
Reported by FDA: October 30, 2024
Distribution: Product was distributed to 125 direct accounts nationwide.

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Drug Recall Terminated Historical recordClass II

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58

by Fresenius Kabi Compounding, LLC

Reason: cGMP violations
Recall initiated: September 25, 2024
Reported by FDA: October 30, 2024
Distribution: Product was distributed to 125 direct accounts nationwide.

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Drug Recall Terminated Historical recordClass II

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58

by Fresenius Kabi Compounding, LLC

Reason: cGMP violations
Recall initiated: September 25, 2024
Reported by FDA: October 30, 2024
Distribution: Product was distributed to 125 direct accounts nationwide.

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Drug Recall Terminated Historical recordClass II

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58

by Fresenius Kabi Compounding, LLC

Reason: cGMP violations
Recall initiated: September 25, 2024
Reported by FDA: October 30, 2024
Distribution: Product was distributed to 125 direct accounts nationwide.

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Drug Recall Terminated Historical recordClass II

Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58

by Fresenius Kabi Compounding, LLC

Reason: CGMP violations
Recall initiated: September 25, 2024
Reported by FDA: October 30, 2024
Distribution: Product was distributed to 125 direct accounts nationwide.

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Data last updated: October 31, 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.