Records and reported status
Aug 4, 2025 FDA drug enforcement
Lack of Assurance of Sterility.
Class II Reported ongoing
Distribution: U.S. Nationwide
Official source for Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, In... Aug 4, 2025 FDA drug enforcement
Lack of Assurance of Sterility.
Class II Reported ongoing
Distribution: U.S. Nationwide
Official source for Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc... Jul 10, 2025 FDA drug enforcement
CGMP Deviations; particulates identified during visual inspection
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial,... Jul 10, 2025 FDA drug enforcement
CGMP Deviations; particulates identified during visual inspection
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial,... May 28, 2025 FDA drug enforcement
Discoloration; discolored solution from cracked vials
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fl... May 20, 2024 FDA drug enforcement
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class II Reported ongoing
Distribution: US Nationwide and Puerto Rico.
Official source for Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartri... May 20, 2024 FDA drug enforcement
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Class II Reported ongoing
Distribution: US Nationwide and Puerto Rico.
Official source for Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile... Dec 21, 2023 FDA drug enforcement
Presence of Particulate Matter; identified as glass
Class I Reported ongoing
Distribution: Nationwide in the USA and Puerto Rico.
Official source for 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syrin... Dec 21, 2023 FDA drug enforcement
Presence of Particulate Matter; identified as glass
Class I Reported ongoing
Distribution: Nationwide in the USA and Puerto Rico.
Official source for 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit ... Dec 21, 2023 FDA drug enforcement
Presence of Particulate Matter; identified as glass
Class I Reported ongoing
Distribution: Nationwide in the USA and Puerto Rico.
Official source for Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Sy... Oct 2, 2023 FDA drug enforcement
Presence of Particulate Matter: identified as glass.
Class I Reported terminated
Distribution: Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.
Official source for 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syring... Oct 2, 2023 FDA drug enforcement
Presence of Particulate Matter: identified as glass.
Class I Reported terminated
Distribution: Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.
Official source for 1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged ... Oct 2, 2023 FDA drug enforcement
Presence of Particulate Matter: identified as glass.
Class I Reported terminated
Distribution: Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.
Official source for 2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged... Mar 8, 2023 FDA drug enforcement
Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
Class III Reported ongoing
Distribution: Nationwide in the USA
Official source for MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma ... Dec 29, 2022 FDA drug enforcement
Lack of assurance of sterility: Bags have the potential to leak.
Class II Reported completed
Distribution: Nationwide in the USA.
Official source for Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection,... Dec 22, 2022 FDA drug enforcement
Presence of Particulate Matter: Glass particulate matter detected in injectable.
Class I Reported terminated
Distribution: USA nationwide and Puerto Rico
Official source for Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial... Sep 27, 2022 FDA drug enforcement
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Class II Reported terminated
Distribution: Distributed in the United States and Puerto Rico.
Official source for Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distribu... Aug 22, 2022 FDA drug enforcement
Presence of particulate matter
Class I Reported terminated
Distribution: USA Nationwide
Official source for PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0... Jul 13, 2022 FDA drug enforcement
Presence of particulate matter: particulate identified as a beetle.
Class I Reported terminated
Distribution: USA Nationwide
Official source for Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (N... Apr 22, 2022 FDA drug enforcement
CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.
Class II Reported terminated
Distribution: Nationwide and Puerto Rico
Official source for Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke...
Reasons in these listed records Lack of Assurance of Sterility. CGMP Deviations; particulates identified during visual inspection Discoloration; discolored solution from cracked vials Lack of Assurance of Sterility-The potential for incomplete crimp seals. These examples come from this result page and are not a ranking of every recall reason.
Checking Pfizer Inc. Is there a recall on pfizer inc. right now? This archive contains 31 records, including 11 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Where can I find older records? Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.