Pfizer recalls
FDA enforcement reports naming Pfizer as the recalling firm.
- Recall reports
- 124
- Class I (serious)
- 17
- Most recent report
- Sep 23, 2026
- Sep 23, 2026Dopamine HCl InjDrug · PfizerLack of Assurance of SterilityClass II
- Aug 27, 2025Vial Label: 8Drug · PFIZER INCLack of Assurance of Sterility.Class II
- Aug 27, 2025Vial Label: Epinephrine Injection, USP, 1mg/10mL (0Drug · PFIZER INCLack of Assurance of Sterility.Class II
- Aug 20, 2025Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, Distrib…Drug · PfizerSubpotent drugClass II
- Aug 6, 2025Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL,…Drug · Pfizer Inc.CGMP Deviations; particulates identified during visual inspectionClass II
- Aug 6, 2025Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL,…Drug · Pfizer Inc.CGMP Deviations; particulates identified during visual inspectionClass II
- Jul 2, 2025DOBUTamine Injection, USP, 250 mg/20 mL (12Drug · Pfizer Inc.Discoloration; discolored solution from cracked vialsClass II
- Jul 3, 2024Buprenorphine Hydrochloride Injection, 0Drug · Pfizer Inc.Lack of Assurance of Sterility-The potential for incomplete crimp seals.Class II
- Jul 3, 2024Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpujec…Drug · Pfizer Inc.Lack of Assurance of Sterility-The potential for incomplete crimp seals.Class II
- Jan 31, 2024Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx O…Drug · PFIZERPresence of particulate matter: glassClass I
- 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBO…
- Atropine Sulfate Injection, USP 1 mg/10 mL (0
- 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of…
- 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of…
- 1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe,…
- 2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe…
- MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array…
- Vancomycin Hydrochloride for Injection, USP, 1
- Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0
- Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only…
- PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop v…
- Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass flipt…
- Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distribut…
- Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distribut…
- Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distribute…
- Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12
- quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only, Distribut…
- quinapril HCl/hydrochlorothiazide tablets, 20 mg/12
- quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only, D…
- Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/25 mg, 90 tablets bottles,…
- Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 20 mg/12
- Accuretic (quinapril HCl/hydrochlorothiazide) Tablets 10 mg/12
- Accuretic (quinapril HCl/hydrochlorothiazide) Tablets, 10 mg/12
- 5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC
- Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets eac…
- Chantix (varenicline) tablets 0
- Chantix (varenicline) tablets 0
- Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, D…
- Chantix (varenicline)Tablets, Contains: 1 Starting Week (0
- Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, D…
- Chantix (varenicline) tablets, 0
- 0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dos…
- 1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial (NDC 0…
- Sterile Water for Inj
- Fentanyl Citrate Inj
- Duavee (conjugated estrogens/bazedoxifene) tablets 0
- Unasyn (ampicillin sodium/sulbacatam) for injection, 1
- Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by P…
- Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-count bottl…
- Fentanyl Citrate Inj
- Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-count bottl…
- 25% Dextrose Injection, USP 2
- 10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, R…
- Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made in Nether…
- ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by: Greensto…
- Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd
- RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per…
- Milrinone Lactate Injection 200 mcg (0
- Milrinone Lactate Injection 200 mcg (0
- Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister pack
- Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL vial, Rx…
- 8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Sin…
- Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by…
- Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed…
- Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed…
- Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial, Rx…
- Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx…
- Levoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle, Rx Only…
- Meropenem for Injection, USA (I
- Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only Distr…
- Magnesium Sulfate in Water for Injection (0
- Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, Rx only, D…
- Argatroban Injection, 250 mg/2
- Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, R…
- Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose V…
- Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose V…
- diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2
- Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig…
- Vancomycin Hydrochloride for Injection, USP
- Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial
- Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactured by Hos…
- Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL…
- Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750mg/150 mL t…
- Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5…
- HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of…
- Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300 mg/60 mL…
- Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 mL…
- Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 mL…
- PROTONIX I
- Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-instit…
- LEVOXYL(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles, Rx only, Ma…
- PREMARIN (conjugated estrogen tablets, USP) 1
- Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roe…
- Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz
- Lyrica (pregabalin) capsules, 50 mg, 90-count bottle, Rx only, Distributed by: Parke-Da…
- Lyrica (pregabalin) capsules, 75 mg, 90-count bottle, Rx only, Distributed by: Parke-Da…
- Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a…
- Xanax (alprazolam) tablets, 0
- Oxecta(TM) (oxycodone HCl) tablets, 7
- Oxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles, Rx only, Manufactured and…
- Tikosyn (dofetilide) 125 mcg (0
- TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL and 1 vial of 2
- Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL, 1 mL Sin…
- Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottle, Rx only…
- VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only, Manufact…
- GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when recon…
- Tikosyn¿ (dofetilide) 500 mcg (0
- Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only, Di…
- Zithromax (azithromycin for injection), 500 mg/vial, Sterile, Rx Only, For I
- Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0
- Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0
- Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a…
- Levoxyl (levothyroxine sodium) tablets, USP 200 mcg, packaged in a) 100-count bottles (…
- Levoxyl (levothyroxine sodium) tablets, USP 88 mcg, packaged in a) 100-count bottles (N…
- Levoxyl (levothyroxine sodium) tablets, USP 75 mcg, packaged in a) 100-count bottles (…
- Levoxyl (levothyroxine sodium) tablets, USP 50 mcg, packaged in a) 100-count bottles (N…
- Levoxyl (levothyroxine sodium) tablets, USP 100 mcg, packaged in a) 100-count bottles (…
- Levoxyl (levothyroxine sodium) tablets, USP 25 mcg, packaged in a) 100-count bottles (N…
- Levoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count bottles (…
- Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-count bottles…
- Levoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count bottles (…
- Levoxyl (levothyroxine sodium) tablets, USP 150 mcg, packaged in a) 100-count bottles (…
- Levoxyl (levothyroxine sodium) tablets, USP 175 mcg, packaged in a) 100-count bottles (…
- TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only, Packaged in a c…
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