PFIZER INC — FDA Compliance Timeline

FDA action counts

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.

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….

Frequently asked questions

How many FDA actions does Argus HQ track for PFIZER INC?

18 total: 0 warning letters, 18 recalls, 0 approval records, and 0 Form 483 inspection citations.

What is the most recent FDA action on file for PFIZER INC?

August 27, 2025. Argus HQ ingests new FDA enforcement records daily.

Has PFIZER INC had product recalls?

Yes, 18 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.

Related enforcement actions

• PFIZER INC — Class II recall: Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx o… →
• PFIZER INC — Class II recall: Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distribut… →
• Pfizer — Class II recall: Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only,… →
• Pfizer Inc. — Class II recall: Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units pe… →
• Pfizer Inc. — Class II recall: Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per… →
• Pfizer Inc. — Class II recall: DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial… →
• Pfizer Inc. — Class II recall: Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpujec… →
• Pfizer Inc. — Class II recall: Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose C… →
• PFIZER — Class I recall: Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop via… →
• Pfizer Inc. — Class I recall: Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJE… →

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