FDA Alerts
2025
MC25-001-CG FDA Astellas recall 1 lot PROGRAF 0.5mg and 1 of ASTAGRAF XL 0.5mg capsules MC25-005-CG FDA - Requires Guillain-Barré Warning in Prescribing Info for RSV Vaccines Abrysvo and Arexvy MC25-006-CG Copaxone, Glatopa FDA Adds Boxed Warning About Serious Allergic Reaction Called Anaphylaxis MC25-007-CG FDA Alvogen recalling 1 lot Fentanyl Transdermal System 25 mcgh transdermal patches MC25-011-CG FDA warns about allergy medicines cetirizine or levocetirizine long-term use may cause itching MC25-012-CG FDA Amneal recall 3 lots of Sulfamethoxazole Trimethoprim Tablets USP 400 mg 80 mg MC25-013-CG FDA Warning About Risk of Heat-Related Complications with Antinausea Patch Transderm Scōp MC25-014-CG FDA Require Expand Label Weight Loss Patients Younger than 6 yrs taking ER Stimulants for ADHD MC25-017-CG FDA - CBER suspended biologics license for Valneva Austria GmbH’s Ixchiq (Chikungunya Vaccine) MC25-018-CG FDA recommend earlier MRI for patients with Alzheimer disease taking Leqembi (lecanemab) MC25-019-CG FDA Removes Risk Evaluation Mitigation Strategies Program for Antipsychotic Drug Clozapine MC25-020-CG FDA Nostrum recall Sucralfate Tablets USP 1 gram all lots within expiry MC25-021-CG FDA Unichem recalling 1 lot Cyclobenzaprine Hydrochloride Tabs USP 10 mg due to Mislabeling MC25-023-CG FDA Nationwide recall atorvastatin calcium tablets 10, 20, 40, 80 milligram doses MC25-024-CG FDA Early Alert Glucose Monitor Sensor - FreeStyle Libre 3 Several Models from Abbott (1)
2024
MC24-003-CG Medicines for Type 2 Diabetes-Obesity - FDA Evaluation Reports of Suicidal Thoughts or Action MC24-005-CG Prolia (denosumab) FDA Adds Boxed Warning for Increase Risk of Hypocalcemia MC24-006-CG Azurity recall 1 lot Zenzedi (dextroamphetamine sulfate tablets, USP) 30 mg Due to a Mislabeled MC24-010-CG Brassica recall Lubricant Eye Ointment Equate, Equate Stye, CVS, Lubricant PM due to Sterility MC24-012-CG MC-Rx Info Series Vol 62 March 2024 Tips for Pharmacies Compounding Practices Focus Semaglutide MC24-013-CG Par Pharmaceutical recall 1 lot Treprostinil Injection 20mg 20mL (1mg mL) MC24-016-CG Eugia recall 1 lot Methocarbamol Injection USP 1000 mg 10 mL 100mg mL Single Dose MC24-017-CG AvKARE recall 1 lot Atovaquone Oral Suspension USP 750 mg 5 mL Due to Contamination MC24-021-CG Dr. Reddys recall 6 lots Sapropterin Dihydrochloride Powder for Oral Solution 100 mg MC24-025-CG FDA warns consumers not use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain MC24-028-CG FDA Glenmark recall 114 batches Potassium Chloride ER Caps USP 750 mg 10 mEq K MC24-029-CG FDA American Health-BluePoint recall 21 batches Potassium Chloride ER Caps USP 750 mg MC24-035-CG FDA - Endo recall 1 lot Clonazepam ODT due to mislabeling incorrect Strength MC24-041-CG FDA Bionpharma recall 1 batch Atovaquone Oral Suspension 750mg due to Contamination MC24-042-CG FDA warning Veozah used for hot flashes due to menopause can cause serious liver injury MC24-049-CG FDA Endo expands its voluntary recall of Clonazepam Orally Disintegrating Tablets USP MC24-050-CG FDA Drug Safety - Ocaliva by Intercept - Serious Liver Injury in Patients without Cirrhosis MC24-052-CG FDA Warning Serious Liver Injury with Use of Veozah (fezolinetant) for Hot Flashes
2023
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MC23-004-CG FDA Spectrum recall 3 lots of Epinephrine (L-Adrenaline) USP due to product discolored
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MC23-011-CG FDA IBSA recall 27 lots TIROSINT-SOL (levothyroxine sodium) Oral Solution due to subpotency
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MC23-012-CG FDA Global recall all lots Artificial Tears Lubricant Eye Drops
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MC23-015-CG FDA Apotex Recall 6 lots Brimonidine Tartrate Ophthalmic Solution, 0.15
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MC23-018-CG FDA Ascend recall Dabigatran Etexilate Caps USP 75 mg and 150 mg due to nitrosamine
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MC23-023-CG FDA Camber recall 1 lot Atovaquone Oral Suspension USP 750mg 5mL due to Bacillus cereus
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MC23-024-CG FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena
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MC23-025-CG FDA Update Prescribing Info to Provide Guidance for Safe Use All Opioid Pain Medicine
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MC23-026-CG FDA Teva recall Specific Lots of FENTANYL Buccal Tablets CII Due to a Labeling Error
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MC23-028-CG FDA Akorn recall various within-expiry human and animal products due to company shutdown
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MC23-031-CG FDA Update Warnings to Improve Safe Use of Prescription Stimulants Used to Treat ADHD
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MC23-033-CG FDA Harvard Drug recall 1 lot Dronabinol Caps USP 2.5mg and Ziprasidone HCL Caps 20mg
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MC23-038-CG FDA Cipla recall 6 batches Albuterol Sulfate Inhalation Aerosol, 90 mcg
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MC23-043-CG FDA Lupin recall 2 lots Tydemy Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tabs
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MC23-047-CG FDA Marlex recall Digoxin Tabs USP, 0.125mg and 0.25mg Due to Label Mix-Up
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MC23-049-CG FDA Novartis recall 1 Lot Sandimmune Oral Sol (Cyclosporine) 100 mgmL due crystallization
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MC23-051-CG FDA change therapeutic equivalence rating for Accord generics Prograf oral caps
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MC23-052-CG FDA VistaPharm recall 1 lot Sucralfate Oral Suspension 1g10mL due to Bacillus
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MC23-054-CG FDA SCYNEXIS recall 2 lots BREXAFEMME (ibrexafungerp tablets) due to cross contamination
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MC23-059-CG FDA KVK-Tech recall 1 lot Betaxolol Tablets USP 10mg due to foreign tablet found on packaging
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MC23-062-CG FDA Bayer Issues Voluntary Recall Nationwide of VITRAKVI® (larotrectinib) Oral Solution 20 mgmL Due to Presence of Microbial Contamination
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MC23-064-CG FDA Novartis issues recall of Sandimmune Solution 100 mgmL due to crystal formation
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MC23-065-CG FDA Drug Safety Communication - FDA Warns of Rare but Serious Drug Reaction
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MC23-067-CG FDA InvaGen Recall 1 lot Vigabatrin for Oral Solution USP 500mg due to Leaking Sachets
FDA Drug Updates
2020