Recalls of pharmaceutical products are a critical component of ensuring patient safety and maintaining public health. The process is governed by regulatory bodies like the U.S. Food and Drug Administration (FDA) and can be initiated for a variety of reasons, including manufacturing defects, contamination, or safety concerns identified after a product has been on the market. In recent years, Pfizer and its subsidiaries have been involved in several notable recalls, impacting a range of products.
Recent Pfizer Recalls (2024-2025)
Bicillin L-A (Penicillin G Benzathine Injectable Suspension)
In July 2025, King Pharmaceuticals LLC, a subsidiary of Pfizer, initiated a voluntary recall for specific lots of Bicillin L-A. This injectable suspension is a key treatment for syphilis and other infections. The recall was prompted by the discovery of particulate matter during visual inspection. The potential risk to patients was assessed as medium, but health authorities advise that affected doses should not be used. This recall is particularly significant given the drug's critical role in treating sexually transmitted infections, and temporary importation of alternative products has been authorized to mitigate shortages.
Octagam (Immune Globulin Intravenous)
In August 2025, Pfizer initiated a recall of Octagam Immune Globulin Intravenous (Human) 10% Liquid Preparation. The reason for the recall was the potential for damaged bottles that may have occurred during transport. Healthcare providers and patients who administer this product were advised to check for potential damage before use.
Oxbryta (Voxelotor) Tablets
One of the most significant recent recalls was the global voluntary withdrawal of Oxbryta (voxelotor) in September 2024. This drug, used to treat sickle cell disease, was pulled from the market after clinical trial data suggested that its risks, including an increased rate of vaso-occlusive crises (VOCs), hospitalizations, and deaths, outweighed its benefits. The withdrawal followed Pfizer's acquisition of the drug's original developer, Global Blood Therapeutics Inc.. Patients were advised to consult their healthcare provider to discuss alternative treatment options. This decision has since led to several lawsuits from individuals who experienced severe complications.
Hospira Product Recalls (2024)
Hospira, a pharmaceutical company owned by Pfizer, recalled specific lots of two injectable drugs in May 2024 due to manufacturing concerns. The recall involved:
- Labetalol Hydrochloride Injection: Used to manage high blood pressure.
- Buprenorphine Hydrochloride Injection: An opioid analgesic used for pain management.
This recall was triggered by a customer complaint about an incomplete crimp seal, which could lead to a lack of therapeutic effect or systemic infection from leaks.
Notable Recalls from Prior Years
Hospira Bleomycin Recall (2023)
In December 2023, Hospira also issued a voluntary nationwide recall for a single lot of Bleomycin for Injection after glass particulate matter was reported in a vial. While the risk was mitigated by instructions to visually inspect the product before use, glass particles in an injectable product could potentially cause localized vein inflammation, blood clots, or other serious adverse events.
Nurtec ODT Packaging Recall (2023)
In March 2023, Pfizer initiated a recall of millions of packages of its migraine drug Nurtec ODT. The reason for the recall was a packaging issue that made it non-compliant with the Poison Prevention Packaging Act, posing a risk of poisoning if accessed by young children. This recall was a precautionary measure focused on packaging safety rather than the drug's efficacy or contamination.
Accuretic and Quinapril-based Drug Recalls (2022)
In March and April 2022, Pfizer voluntarily recalled several hypertension medications, including lots of Accuretic (quinapril HCl/hydrochlorothiazide), Accupril (quinapril HCl), and their generic versions. The recall was due to the presence of N-nitroso-quinapril, a nitrosamine impurity found above the acceptable daily intake level. While nitrosamines are potential carcinogens with long-term exposure, Pfizer stated there was no immediate risk to patients.
The Recall Process and Patient Action
When a drug is recalled, the FDA classifies it based on the level of health hazard:
- Class I Recall: For dangerous or defective products that could cause serious health problems or death.
- Class II Recall: For products that might cause a temporary health problem or pose a slight threat of a serious nature.
- Class III Recall: For products that are unlikely to cause any adverse health reaction but violate FDA regulations.
Patients should take any recall seriously, but also avoid making rash decisions. Stopping a critical medication suddenly can be more dangerous than continuing it briefly. Always consult a doctor or pharmacist for guidance.
Comparison of Recent Pfizer-Related Recalls
| Recalled Product | Recall Date (Approx.) | Primary Reason for Recall | Health Hazard Class | Patient Action Advised |
|---|---|---|---|---|
| Oxbryta (Voxelotor) | September 2024 | Increased severe side effects (VOCs, hospitalization, death) | Most likely Class I | Consult doctor for alternative treatment |
| Bicillin L-A | July 2025 | Particulate matter contamination | Class II (Medium Risk) | Do not use affected lots; seek alternatives |
| Hospira Injections | May 2024 | Incomplete crimp seals causing potential leaks | Medium risk | Discontinue use, return product |
| Hospira Bleomycin | December 2023 | Glass particulate contamination | Risk of embolism | Check vial for particulates before use; return affected lot |
| Nurtec ODT | March 2023 | Non-child-resistant packaging | Potential for poisoning | Return affected packaging |
| Accuretic & generics | March/April 2022 | N-nitroso-quinapril impurity | Potential cancer risk with long-term use | Consult doctor about alternative options |
What to Do If Your Medication is Recalled
If you discover that your medication has been recalled, take the following steps:
- Verify the recall: Check the lot number on your medication bottle or packaging against the official recall notice. The lot number is usually near the expiration date and is not the same as the National Drug Code (NDC).
- Do not panic: For most recalls, the risk is not immediate. The most dangerous action is often to suddenly stop a necessary medication without consulting a healthcare professional.
- Contact your healthcare provider: Speak with your doctor or pharmacist to determine if your prescription is affected and to receive guidance on safe disposal and alternative treatment.
- Arrange for return or disposal: Follow the specific instructions provided by the manufacturer or pharmacy for returning the recalled product for a refund or replacement.
- Stay informed: Pay attention to alerts from official sources like the FDA and CDC for updates on medication safety. For information on the Bicillin L-A recall, the CDC has provided important guidance: https://www.cdc.gov/sti/php/from-the-director/2025-07-bicillin-recall.html.
Conclusion: Staying Vigilant with Medication Safety
Pfizer, like any major pharmaceutical company, issues recalls to protect patients from potential harm associated with its products. These events, from the significant withdrawal of Oxbryta to the Bicillin L-A particulate recall, underscore the industry's commitment to self-regulation and safety standards. For patients, the key is to stay informed, calmly verify any recall information against the medication they possess, and always consult with a trusted healthcare provider before making any changes to their treatment plan. The most reliable information on what drugs are being recalled from Pfizer can always be found on official health authority websites, such as the FDA's Safety and Recalls page.
