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Prescription and over-the-counter medication recalls

Drug recalls come from the FDA's drug enforcement reports. They range from a wrong label to a product that could be harmful, and the risk level on each notice is the FDA's own classification. Never stop a prescribed medication on the strength of a recall notice alone — the notice will say whether to return it, and your prescriber or pharmacist decides what replaces it.

4,474 stored notices, reported between Jun 20, 2012 and Sep 9, 2026. Newest first.

Drugs

Reported Aug 15, 2012

HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Hospira Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Aug 15, 2012

Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Nephron Pharmaceuticals Corp.

FDA (openFDA drug enforcement)

Drugs

Reported Aug 15, 2012

OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D Cylinder 425L, and M6 Cylinder 165L,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Oklahoma Respiratory Care Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Aug 15, 2012

Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Teva Pharmaceuticals USA, Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Aug 8, 2012

Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Apotex Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Aug 8, 2012

Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 mL.) 80 mg. per 0.8 mL, Cherry Flavor,…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Axcentria Pharmaceuticals LLC

FDA (openFDA drug enforcement)

Drugs

Reported Aug 8, 2012

Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 165811,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Bayer HealthCare Pharmaceuticals Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Aug 8, 2012

OFIRMEV (acetaminophen) injection, 1000 mg/100 mL (10 mg/mL), 24-count Single Use 100 mL Vials per carton, Rx only,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Cadence Pharmaceuticals

FDA (openFDA drug enforcement)

Drugs

Reported Aug 8, 2012

Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 500 Capsules, Rx only, Mfd. By: Dr. Reddy's…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Dr. Reddy's Laboratories, Inc.

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Aug 8, 2012

Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07),…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Eagle Pharmaceuticals Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Aug 8, 2012

Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only,…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Mallinckrodt Inc.

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Aug 8, 2012

Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

VistaPharm, Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Aug 8, 2012

Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Watson Laboratories Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Aug 8, 2012

Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dose Vial, packaged in 25-count x…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

West-ward Pharmaceutical Corp.

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Aug 8, 2012

Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Zydus Pharmaceuticals USA Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Aug 1, 2012

Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. FOUGERA & CO., A division of Fougera…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Fougera Pharmaceuticals, Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Aug 1, 2012

Dent's Extra Strength Toothache Gum, (benzocaine 20%), Net Wt. .035 Oz.. (1 g) box, C.S. Dent & Co., Erlanger, KY

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Grandpa Brands Co.

FDA (openFDA drug enforcement)

Drugs

Reported Aug 1, 2012

Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Stat Rx USA

FDA (openFDA drug enforcement)

Drugs

Reported Jul 25, 2012

Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Bayer Healthcare, LLC

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Jul 25, 2012

Morphine Sulfate Injection, USP, 4mg/mL, 1 mL fill in 2.5 mL Carpuject Cartridge Unit with Luer Lock, packaged 10…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Hospira Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Jul 25, 2012

Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, Manufactured and Distributed by: JHP…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

JHP Pharmaceuticals, LLC

FDA (openFDA drug enforcement)

Drugs

Reported Jul 25, 2012

Epinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and IM Use, For IV and IC Use after Dilution,…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Luitpold Pharmaceuticals, Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Jul 25, 2012

Prefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC industries, Inc. Irving ton, NJ 07111, For:…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Meda Pharmaceuticals Inc.

FDA (openFDA drug enforcement)

Drugs

Reported Jul 25, 2012

Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufactured in India by: Unique Pharmaceutical…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Pack Pharmaceuticals

FDA (openFDA drug enforcement)

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Related categories

RecallNow is not a government agency. Every notice above was published by the FDA, USDA FSIS or CPSC and links back to its source. Browse the whole archive.