Has PFIZER INC had product recalls?

Yes, 16 recalls on file. See the full history below for each one.

Is this FDA enforcement data for PFIZER INC official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

How many FDA actions has PFIZER INC had?

Argus HQ has recorded 16 FDA events for PFIZER INC: 0 warning letters, 16 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

What is the most recent FDA action against PFIZER INC?

The most recent FDA event Argus HQ has on file for PFIZER INC is dated 2025-08-27, with a severity rating of "critical" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

FDA Enforcement History: PFIZER INC

Here's the summary: Argus HQ has recorded 16 FDA events for PFIZER INC: 0 warning letters, 16 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2023-01-11 to 2025-08-27. The most severe rating Argus HQ has assigned across this history is "critical". Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

FDA action counts

Total FDA actions	16
Warning letters	0
Recalls	16
Approval records	0
Form 483 inspection citations	0
Most recent action	August 27, 2025

Enforcement history

On 2025-08-27, Argus HQ recorded an FDA recall for PFIZER INC, rated "high" severity in Argus HQ's classification: PFIZER INC — Class II recall: Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distribut…. On 2025-08-27, Argus HQ recorded an FDA recall for PFIZER INC, rated "high" severity in Argus HQ's classification: PFIZER INC — Class II recall: Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx o…. On 2025-08-06, Argus HQ recorded an FDA recall for PFIZER INC, rated "high" severity in Argus HQ's classification: Pfizer Inc. — Class II recall: Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per…. On 2025-08-06, Argus HQ recorded an FDA recall for PFIZER INC, rated "high" severity in Argus HQ's classification: Pfizer Inc. — Class II recall: Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units pe…. On 2025-07-02, Argus HQ recorded an FDA recall for PFIZER INC, rated "high" severity in Argus HQ's classification: Pfizer Inc. — Class II recall: DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial…. On 2024-07-03, Argus HQ recorded an FDA recall for PFIZER INC, rated "high" severity in Argus HQ's classification: Pfizer Inc. — Class II recall: Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose C…. On 2024-07-03, Argus HQ recorded an FDA recall for PFIZER INC, rated "high" severity in Argus HQ's classification: Pfizer Inc. — Class II recall: Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpujec…. On 2024-01-24, Argus HQ recorded an FDA recall for PFIZER INC, rated "critical" severity in Argus HQ's classification: Pfizer Inc. — Class I recall: 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Gla…. On 2024-01-24, Argus HQ recorded an FDA recall for PFIZER INC, rated "critical" severity in Argus HQ's classification: Pfizer Inc. — Class I recall: 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT…. On 2024-01-24, Argus HQ recorded an FDA recall for PFIZER INC, rated "critical" severity in Argus HQ's classification: Pfizer Inc. — Class I recall: Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJE…. On 2023-11-15, Argus HQ recorded an FDA recall for PFIZER INC, rated "critical" severity in Argus HQ's classification: Pfizer Inc. — Class I recall: 2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use…. On 2023-11-15, Argus HQ recorded an FDA recall for PFIZER INC, rated "critical" severity in Argus HQ's classification: Pfizer Inc. — Class I recall: 1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use S….

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. PFIZER INC has 16 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Frequently asked questions

Has PFIZER INC had product recalls?: Yes, 16 recalls on file. See the full history below for each one.
Is this FDA enforcement data for PFIZER INC official?: Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.
How many FDA actions has PFIZER INC had?: Argus HQ has recorded 16 FDA events for PFIZER INC: 0 warning letters, 16 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
What is the most recent FDA action against PFIZER INC?: The most recent FDA event Argus HQ has on file for PFIZER INC is dated 2025-08-27, with a severity rating of "critical" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

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Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Verified from FDA.gov · Last updated: Aug 27, 2025

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2025). FDA Enforcement History: PFIZER INC. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/company/pfizer-inc

MLA

"FDA Enforcement History: PFIZER INC." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/company/pfizer-inc.

Chicago

Argus HQ Research. "FDA Enforcement History: PFIZER INC." Digital Empire Holdings LLC. Accessed July 17, 2026. https://argushq.ai/company/pfizer-inc.

BibTeX

@misc{argushq_argushq_ai_company_pfizer_inc_2025,
  title = {FDA Enforcement History: PFIZER INC},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/company/pfizer-inc},
  note = {Accessed: July 17, 2026}
}

Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗