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Browse Drug Recalls

201 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 201 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 201 FDA drug recalls.

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DateProductReasonClassFirm
Jul 17, 2015 lidocaine HCl, 1%, 30 mg per 3 mL, 3 mL Total Volume in a syringe, Rx only, P... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 lidocaine HCl, 2%, Preservative Free, Total Volume 2mL, Product code 2R3323, ... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 HYDROmorphone HCl, 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume i... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 methadone HCl, 10 mg per mL, 1 mL Total Volume in a syringe, For IV Use Only,... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 1... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 remifentanil HCl, 50 mcg per mL, 100 mcg per 2 mL, in 0.9% Sodium Chloride, P... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 lidocaine HCl, 0.5%, 5 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume ... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 labetalol HCl, 5 mg per mL, 20 mg per 4 mL, 4 mL total Volume in a syringe, F... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 fentaNYL Citrate, 25 mcg per mL in 0.9% Sodium chloride, 1 mL Total Volume in... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 neostigmine Methylsulfate, 1 mg per mL, 2 mg per 2 mL, 2 mL Total Volume in a... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium ... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 lidocaine HCl, 2%, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syr... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free (... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Prese... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 midazolam HCl, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Tot... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free, ... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a sy... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 lidocaine HCl, 1%, 10 mg per 1 mL, 1 mL Total Volume in a syringe, Rx only, P... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 glycopyrrolate, 0.2 mg per mL, 0.6 mg per 3 mL, 3 mL Total Volume in a syring... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 lidocaine HCl, 1%, 10 mg per mL (50 mg per 5 mL), 5 mL Total Volume in a syri... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 midazolam HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a s... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 succinylcholine Chloride Injection, 20 mg per mL, 100 mg per 5 mL, 5 mL Total... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 fentaNYL Citrate, 5 mcg per mL, 15 mcg per 3mL, in 0.9% Sodium chloride, 3 mL... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume, Product ... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 morphine Sulfate, 2 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in ... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Tot... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 HYDROmorphone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 ketamine HCl, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL Tot... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Prese... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Apr 20, 2015 IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02,... Subpotent Drug: Low out-of-specification potency result of the drug product. Class III Akorn, Inc.
Apr 2, 2015 Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 co... Subpotent Drug: The firm received an out of specification result for Assay (potency was below spe... Class II Boehringer Ingelheim Roxane Inc
Oct 30, 2014 Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500... Subpotent Drug: Heparin raw material was found to have low potency Class II Baxter Healthcare Corp.
Oct 2, 2014 VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-co... Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point. Class II West-Ward Pharmaceutical Corp.
Apr 29, 2014 Red Yeast Rice High Potency Dietary Supplement, 600 mg, packaged in a) 120-co... Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovas... Class II Independent Nutrition Center, Inc.
Feb 7, 2014 Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use... Subpotent Drug: Drug potency was compromised during shipment. Class III Actavis
Nov 4, 2013 Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade, 45... Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclare... Class I IQ Formulations, LLC
Oct 21, 2013 Human Chorionic Gonadotropin, EP (HCG) in 5 mu. 2 mu, and 1 mu packages, For ... Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was fo... Class I Medisca Inc.
Aug 14, 2013 72HP MAXIMUM POTENCY MALE SEXUAL ENHANCEMENT, Dietary Supplement, supplied in... Marketed without an Approved NDA/ANDA: products were found to contain undeclared sildenafil Class I Fabscout Entertainment, Inc
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 125 mcg, packaged in a) 100-coun... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 100 mcg, packaged in a) 100-coun... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 75 mcg, packaged in a) 100-count... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 200 mcg, packaged in a) 100-coun... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 150 mcg, packaged in a) 100-coun... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 50 mcg, packaged in a) 100-count... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 112 mcg, packaged in a) 100-coun... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 25 mcg, packaged in a) 100-count... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 175 mcg, packaged in a) 100-coun... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 88 mcg, packaged in a) 100-count... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer
Apr 30, 2013 Levoxyl (levothyroxine sodium) tablets, USP, 137 mcg, packaged in a) 100-coun... Subpotent Drug: The products were below specification for potency at the expiry stability point. Class II King Legacy, a wholly owned subsidiary of Pfizer

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.