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Browse Drug Recalls

515 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 515 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 515 FDA drug recalls.

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DateProductReasonClassFirm
May 5, 2016 16.67 mcg/mL Fentanyl Citrate and 0.1667% Bupivacaine HCl (Preservative Free)... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 10 mcg/mL Fentanyl Citrate and 0.2% 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
May 5, 2016 2 mcg/mL Fentanyl Citrate and 0.25% 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 0.0625% 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 20 mcg/mL HYDROmorphone HCl and 0.1% 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
May 5, 2016 5 mcg/mL Fentanyl Citrate and 0.125% 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
May 5, 2016 0.15% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in ... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 20 mcg/mL Fentanyl Citrate and 0.125% 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 3 mcg/mL Fentanyl Citrate and 0.01% 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
May 5, 2016 5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 0.4 mcg/mL Sufentanil Citrate and 0.0625% Bupivacaine HCl (Preservative Free)... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 5 mcg/mL Fentanyl Citrate and 0.0625% 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 10 mcg/mL Fentanyl Citrate and 0.1% 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
May 5, 2016 4 mcg/mL Fentanyl Citrate and 0.125% 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
May 5, 2016 5 mcg/mL HYDROmorphone HCl and 0.125% 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 0.05 mg/mL Morphine Sulfate and 0.0625% Bupivacaine HCI (Preservative Free) i... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 10 mcg/mL Fentanyl Citrate and 0.0625% 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 5 mcg/mL Fentanyl Citrate and 0.04% 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
May 5, 2016 6.66 mcg/mL Fentanyl Citrate and 0.22% 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 0.2% Bupivacaine HCl (Preservative Free) in 0.9... Presence of Particulate Matter: API contaminated with glass particulate was used to produce steri... Class II Pharmedium Services, LLC
May 5, 2016 1 mcg/mL Sufentanil Citrate and 0.1% 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
May 5, 2016 0.5 mcg/mL Sufentanil Citrate and 0.1% 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 0.4 mcg/mL Sufentanil Citrate and 0.1% 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 0.125% 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
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
Apr 25, 2016 Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Do... Presence of Particulate Matter: Glass particulate found in sterile injectable product Class II Fresenius Kabi USA, LLC
Apr 7, 2016 Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 ... Presence of Particulate Matter Class II Akorn, Inc.
Mar 23, 2016 Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, ... Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter. Class I Hospira Inc.
Mar 18, 2016 8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL),... Presence of Particulate Matter: particulate matter identified as an insect in one vial. Class I Hospira Inc.
Mar 9, 2016 Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manu... Presence of Particulate Matter: particulate matter identified as glass in one vial. Class I Teva Pharmaceuticals USA
Feb 16, 2016 Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, Fo... Presence of Particulate Matter: Glass particles found in the product after reconstitution. Class II Genzyme Corporation
Feb 16, 2016 Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, Fo... Presence of Particulate Matter: Glass particles found in the product after reconstitution. Class II Genzyme Corporation
Feb 5, 2016 0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthca... PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identifi... Class II Baxter Healthcare Corp.
Jan 21, 2016 CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose... Presence of Particulate Matter: identified as dried skin. Class I Baxter Healthcare Corp.
Jan 21, 2016 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX S... Presence of Particulate Matter: identified as cardboard. Class I Baxter Healthcare Corp.
Jan 21, 2016 Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Singl... Presence of Particulate Matter: identified as a cloth fiber. Class I Baxter Healthcare Corp.
Dec 15, 2015 Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bu... Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in th... Class I Baxter Healthcare Corp.
Dec 15, 2015 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx... Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in th... Class I Baxter Healthcare Corp.
Nov 4, 2015 Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G 5/16" Syringe f... Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes fo... Class II Pine Pharmaceuticals, LLC
Nov 4, 2015 Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal inje... Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes fo... Class II Pine Pharmaceuticals, LLC
Nov 4, 2015 Bevacizumab 2 mg/0.08 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -... Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes fo... Class II Pine Pharmaceuticals, LLC
Nov 4, 2015 Bevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal Rx... Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes fo... Class II Pine Pharmaceuticals, LLC
Oct 29, 2015 HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton,... Presence of Particulate Matter Class II Amerisource Health Services
Oct 7, 2015 HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 3000 count bottles, Rx only, Manu... Presence of Particulate Matter. Class II Vintage Pharmaceuticals LLC, DBA Qualitest Phar...
Aug 25, 2015 1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservati... Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded i... Class II Hospira, Inc.
Aug 24, 2015 Refresh P.M. (Mineral Oil 42.5% and White Petrolatum 57.3%) Lubricant Eye Oin... Presence of Particulate Matter: Due to customer complaints of small black particles, identified a... Class II Allergan Sales, LLC
Aug 24, 2015 BLEPHAMIDE (sulfacetamide sodium and prednisolone acetate ophthalmic ointment... Presence of Particulate Matter: Due to customer complaints of small black particles, identified a... Class II Allergan Sales, LLC
Aug 24, 2015 FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan... Presence of Particulate Matter: Due to customer complaints of small black particles, identified a... Class II Allergan Sales, LLC
Aug 24, 2015 Refresh Lacri-Lube (Mineral Oil 42.5% and White Petrolatum 56.8%) Lubricant E... Presence of Particulate Matter: Due to customer complaints of small black particles, identified a... Class II Allergan Sales, 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.