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Browse Drug Recalls

291 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 291 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 291 FDA drug recalls.

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DateProductReasonClassFirm
May 5, 2016 10 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) in... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
Dec 31, 2015 NORepinephrine Bitartrate, 8 mg (32 mcg/mL) added to 250 mL 0.9% Sodium Chlor... Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration Class III Pharmedium Services, LLC
Dec 31, 2015 NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chlor... Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration Class III Pharmedium Services, LLC
Jul 21, 2015 Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. ... Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-... Class II Pharmedium Services, LLC
Jul 17, 2015 fentaNYL Citrate Injection, 50 mcg per mL (100 mcg per 2 mL), 2 mL Total Volu... 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 (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 m... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 ePHEDrine Sulfate, 10 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 methadone 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 morphine Sulfate, 1 mg per mL (5 mg per 5 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 atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volu... 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, 20 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 PHENYLephrine HCl, 40 mcg per mL, 200 mcg per 5 mL, in 0.9% Sodium Chloride, ... 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, 0.4 mg per 2 mL, 2 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 ketamine HCl, 10 mg per mL, 50 mg per 5 mL, 0.9% Sodium Chloride, 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 HYDROmorphone HCl, 0.2 mg per mL, (0.4 mg per 2 mL), in 0.9% Sodium Chloride,... 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, 2.5 mg per 0.5 mL, in 0.9% Sodium Chloride, 0.5 mL Total Volum... 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, 1 mg per 5 mL, 5 mL Total Volume in a syringe,... 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 Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volu... Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential los... Class II Pharmedium Services, LLC
Jul 17, 2015 fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free... Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in s... Class I Pharmedium Services, LLC
Jul 17, 2015 Buffered Lidocaine, 2%, In Sodium Bicarbonate 8.4%, 3 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 mL (50 mg per 5 mL), Preservative Free, 5 mL Tota... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 ePHEDrine Sulfate, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, Pre... 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, 5 mg per 5 mL, 5 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 midazolam HCl, 1 mg per mL (3 mg per 3 mL), in 0.9% Sodium Chloride, 3 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 lidocaine HCl 2%, Preservative Free, 20 mg per mL (100 mg per 5 mL), 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 HEPARIN Sodium Inj. USP, 3,000 USP Heparin Units per 3 mL Total Volume in a s... Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential los... Class II Pharmedium Services, LLC
Jul 17, 2015 neostigmine Methylsulfate, 1 mg per mL, 3 mg per 3 mL, 3 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, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 m... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 HEPARIN Sodium Inj., USP, 5,000 USP Heparin Units per 5 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, 10 mcg per mL (25 mcg per 2.5 mL), in 0.9% Sodium Chloride,... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 HEPARIN Sodium Inj. USP, 15,000 USP Heparin Units per 3 mL Injection 3 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 lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 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 ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL, in 0.9% Sodium Chloride, Pres... 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, 0.9% Sodium Chloride, Preservative Free, 1 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 lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 3... 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 Injection, 50 mg per mL (100 mg per 2 mL), 2 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 PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, ... 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 Injection, 50 mg per mL, 1 mL Total Volume in a syringe, For IV ... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 atropine Sulfate Injection, 0.4 mg per mL, 0.8 mg per 2 mL, 2 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 PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, ... 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 Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volu... 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 Injection, 50 mcg per mL, 250 mcg per 5 mL, 5mL 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 lidocaine HCl, 2%, 40 mg per 2 mL, 2 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, 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

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.