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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

Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD 25 ml. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

by Guardian Pharmacy Services

Reason: Lack of sterility assurance.
Recall initiated: May 17, 2018
Reported by FDA: August 15, 2018
Distribution: Texas

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Drug Recall Terminated Historical recordClass III

Testosterone 200 mg Pellet, Rx only, Carie Boyd's Prescription Shop 122 Grapevine Hwy., Hurst, TX 76054, 800-930-4361

by Right Value Drug Stores, Inc.

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label
Recall initiated: July 26, 2018
Reported by FDA: August 15, 2018
Distribution: Nationwide with the United States

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Drug Recall Terminated Historical recordClass II

Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-667-30

by Akorn, Inc.

Reason: Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
Recall initiated: August 1, 2018
Reported by FDA: August 15, 2018
Distribution: Nationwide within the USA

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Drug Recall Terminated Historical recordClass II

10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.

by PharMEDium Services, LLC

Reason: CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Recall initiated: July 24, 2018
Reported by FDA: August 15, 2018
Distribution: Product was distributed throughout the United States

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Drug Recall Terminated Historical recordClass II

5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDium Services, LLC.

by PharMEDium Services, LLC

Reason: CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Recall initiated: July 24, 2018
Reported by FDA: August 15, 2018
Distribution: Product was distributed throughout the United States

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Drug Recall Terminated Historical recordClass II

10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag, PharMEDium Services, LLC.

by PharMEDium Services, LLC

Reason: CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Recall initiated: July 24, 2018
Reported by FDA: August 15, 2018
Distribution: Product was distributed throughout the United States

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Drug Recall Terminated Historical recordClass II

Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-212-08.

by Morton Grove Pharmaceuticals, Inc.

Reason: Defective Container: Tamper Evident foil seal not completely intact.
Recall initiated: July 24, 2018
Reported by FDA: August 15, 2018
Distribution: U.S. Nationwide

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Drug Recall Terminated Historical recordClass III

Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating jelly and instructions for use per carton, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807; Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215; NDC 68682-650-20.

by Valeant Pharmaceuticals North America LLC

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
Recall initiated: July 10, 2018
Reported by FDA: August 15, 2018
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count box (NDC 45567-0040-1), b) 30-count box, NDC 45567-0040-2 , Rx only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.

by Pharmalucence, Inc.

Reason: Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Recall initiated: June 6, 2018
Reported by FDA: August 15, 2018
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Valsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4183-3

by NuCare Pharmaceuticals Inc

Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: July 30, 2018
Reported by FDA: August 15, 2018
Distribution: Distributed to three customers in Fl and CA

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Drug Recall Terminated Historical recordClass II

Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4311-9

by NuCare Pharmaceuticals Inc

Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: July 30, 2018
Reported by FDA: August 15, 2018
Distribution: Distributed to three customers in Fl and CA

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Drug Recall Terminated Historical recordClass III

Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-048-24.

by Baxter Healthcare Corporation

Reason: Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Recall initiated: August 1, 2018
Reported by FDA: August 15, 2018
Distribution: Nationwide USA and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-047-24.

by Baxter Healthcare Corporation

Reason: Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Recall initiated: August 1, 2018
Reported by FDA: August 15, 2018
Distribution: Nationwide USA and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-046-24.

by Baxter Healthcare Corporation

Reason: Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Recall initiated: August 1, 2018
Reported by FDA: August 15, 2018
Distribution: Nationwide USA and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01

by Lupin Pharmaceuticals Inc.

Reason: Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Recall initiated: July 26, 2018
Reported by FDA: August 8, 2018
Distribution: Product was distributed throughout the United States

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Drug Recall Terminated Historical recordClass III

Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC a) 36000-002-10 and b) 36000-002-06.

by Renaissance Lakewood, LLC

Reason: Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
Recall initiated: July 11, 2018
Reported by FDA: August 8, 2018
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-002-10.

by Renaissance Lakewood, LLC

Reason: Failed Stability Specifications: lot out of specification for elevated water vapor.
Recall initiated: July 11, 2018
Reported by FDA: August 8, 2018
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India; NDC 36000-003-06.

by Renaissance Lakewood, LLC

Reason: Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
Recall initiated: July 11, 2018
Reported by FDA: August 8, 2018
Distribution: Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.

by Bryant Ranch Prepack Inc.

Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: July 27, 2018
Reported by FDA: August 8, 2018
Distribution: Product was distributed in HI, IN, and FL.

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Drug Recall Terminated Historical recordClass II

Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (NDC 6362-96905-3), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.

by Bryant Ranch Prepack Inc.

Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall initiated: July 27, 2018
Reported by FDA: August 8, 2018
Distribution: Product was distributed in HI, IN, and FL.

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Data last updated: September 23, 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.