OpenFDA Live Enforcement API Feed

FDA Drug Safety & Counterfeit Warnings

Real-time public safety alerts from the US Food and Drug Administration (FDA) regarding illicit adulterants (Xylazine, Fentanyl) and pharmaceutical batch recalls.

D-321-2016Class II

Initiation Date: 20150903

Product Identification:

Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

⚠️ Reason for FDA Action: Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Distribution Area: NationwideStatus: Terminated

D-0080-2021Class II

Initiation Date: 20200730

Product Identification:

Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 fl oz / 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico.UPC 639277928610

⚠️ Reason for FDA Action: CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Distribution Area: USA NationwideStatus: Ongoing

D-0115-2026Class II

Initiation Date: 20251015

Product Identification:

Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-04

⚠️ Reason for FDA Action: Lack of Assurance of Sterility

Distribution Area: TX and UTStatus: Ongoing

D-1285-2020Class II

Initiation Date: 20200522

Product Identification:

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 5 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0971-02

⚠️ Reason for FDA Action: Some bottles may contain mixed strengths of the product.

Distribution Area: Nationwide within the United State and Puerto Rico.Status: Terminated

D-0623-2022Class II

Initiation Date: 20211026

Product Identification:

No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA. NDC 41163-703-10

⚠️ Reason for FDA Action: CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Distribution Area: Nationwide in the USAStatus: Terminated

D-1398-2016Class II

Initiation Date: 20160505

Product Identification:

2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8102, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-102-48

⚠️ Reason for FDA Action: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Distribution Area: NationwideStatus: Terminated

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