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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
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
May 22, 2015 Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL... Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay. Class I Pharmedium Services, LLC
Apr 13, 2015 HEPARIN Sodium Injection USP 25,000 USP Units added to 250 mL 5% Dextrose Inj... Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, ... Class I Pharmedium Services, LLC
Apr 13, 2015 EPINEPHrine HCl 1 mg added to 250 mL 0.9% Sodium Chloride Injection USP (4 mc... Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, ... Class I Pharmedium Services, LLC
Apr 13, 2015 oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP, packaged in 250 ... Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, ... Class I Pharmedium Services, LLC
Apr 13, 2015 EPINEPHrine HCl 16 mg added to 250 mL 0.9% Sodium Chloride Injection USP (64 ... Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, ... Class I Pharmedium Services, LLC
Apr 13, 2015 EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP (16 m... Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, ... Class I Pharmedium Services, LLC
Apr 13, 2015 HEPARIN Sodium Injection USP, 12,500 USP Units added to 250 mL 5% Dextrose In... Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, ... Class I Pharmedium Services, LLC
Jan 28, 2015 Morphine Sulfate, 1 mg per mL (250 mg per 250 mL), 250 mL total volume in a 2... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 Bupivacaine HCl 0.0625%, 250 mL total volume in a 250 mL LifeCare Bag in Sodi... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 PHENYLephrine HCl, 40 mg added to 250 mL 0.9% Sodium Chloride Injection USP (... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 PHENYLephrine HCl, 10 mg added to 250 mL 0.9% Sodium Chloride Injection USP (... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 Fentanyl Citrate, 5 mcg per mL (1,250 mcg per 250 mL), 250 mL total volume in... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 PHENYLephrine HCl, 20 mg added to 250 mL 0.9% Sodium Chloride Injection USP (... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 PHENYLephrine HCl, 50 mg added to 250 mL 0.9% Sodium Chloride Injection USP (... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 PHENYLephrine HCl, 60 mg added to 250 mL 0.9% Sodium Chloride Injection USP (... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 13, 2015 fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 ... Subpotent Drug Class I Pharmedium Services, LLC
Jan 13, 2015 fentaNYL Citrate, Preservative Free, 10 mcg per 1 mL In 0.9% Sodium Chloride,... Subpotent Drug Class I 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.