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Browse Drug Recalls

1,301 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,301 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 1,301 FDA drug recalls in IL.

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DateProductReasonClassFirm
Aug 27, 2014 Morphine sulfate (PF) 3 mg/mL injectable packaged in 30 mL or 60 mL syringes,... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Quad mix, 30 mg/1 mg/10 mcg/0.15 mg/mL (papaverine, phentolamine mesylate, al... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Phenylephrine 10% opthalmic solution packaged in an opaque squeeze bottle eye... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Tri-mix ST9-B, 30 mg/2 mg/100 mcg/mL (papaverine, phentolamine mesylate, alpr... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Tri-mix, 30 mg/1 mg/20 mcg/mL (papaverine, phentolamine mesylate, alprostadil... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Methylcobalamin (PF) 1 mg/mL injectable packaged in an amber glass injectable... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Atropine sulfate 2 mg/mL injectable packaged in an amber glass injectable via... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Sodium tetradecyl sulfate 3% (PF) injectable packaged in an amber glass injec... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Hydromorphone HCl (PF) 1 mg/mL injectable packaged in 30 mL or 60 mL syringes... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Opthalmic ointment base ointment packaged in a white ointment tube, Martin Av... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Dexamethasone sodium phosphate 4 mg/mL injectable packaged in an amber glass ... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Methylcobalamin 1 mg/mL injectable packaged in an amber glass injectable vial... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Histamine 0.55 mg/mL injectable packaged in an amber glass injectable vial, M... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Atropine sulfate 0.01% opthalmic solution packaged in a squeeze bottle eye dr... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Rescue solution with triamcinolone (lidocaine, bupivacaine, heparin, triamcin... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Tri-mix ST2, 30 mg/3 mg/100 mcg/mL (papaverine, phentolamine mesylate, alpros... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Vancomycin 50 mg/mL opthalmic solution packaged in an opaque squeeze bottle e... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Tri-mix T50, 8.825 mg/0.29 mg/2.95 mcg/mL (papaverine, phentolamine mesylate,... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Chorionic gonadotropin/mannitol 10000 U/0.1 gm powder packaged in a white jar... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Methylcobalamin 25 mg/mL injectable packaged in an amber glass injectable via... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Phenol 10% injectable packaged in an amber glass injectable vial, Martin Aven... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Quad mix, 18 mg/0.2 mg/10 mcg/0.02 mg/mL (papaverine, phentolamine mesylate, ... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Quad mix 2, 12 mg/1 mg/25 mcg/0.25 mg/mL (papaverine, phentolamine mesylate, ... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Fentanyl injectable 6000 mcg/mL packaged in 30 mLor 60 mL syringes, Martin Av... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Voriconazole 10 mg/mL opthalmic solution packaged in an opaque squeeze bottle... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Hydroxyzine hydrochloride 25 mg/mL injectable packaged in an amber glass inje... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Benzalkonium chloride water for injection packaged in an amber glass injectab... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Hyaluronidase injection solution (PF) 150 U/mL injectable packaged in an ambe... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Quad mix, 9 mg/1 mg/10 mcg/0.1 mg/mL (papaverine, phentolamine mesylate, alpr... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Phentolamine mesylate 5 mg/35 mg/mannitol trituration packaged in a white jar... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 13, 2014 PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx o... CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several cr... Class II Fresenius Kabi USA, LLC
Aug 7, 2014 Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextro... Presence of Particulate Matter: particulate matter was found during the manufacturing process. Class I Baxter Healthcare Corp.
Aug 5, 2014 Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass... Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl im... Class III Akorn, Inc.
Aug 4, 2014 ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container ... Presence of Particulate Matter: identification of particulates in a retention sample that have be... Class II Baxter Healthcare Corp
Jul 30, 2014 0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxte... Lack of Assurance of Sterility; complaints of mold in the overpouch Class II Baxter Healthcare Corp.
Jul 29, 2014 Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Singl... Presence of Particulate Matter: The product was discolored and contained visible particulates (ir... Class I Hospira Inc.
Jul 11, 2014 0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container ba... Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. Class I Baxter Healthcare Corp.
Jul 11, 2014 Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Con... Presence of Particulate Matter: particulate matter identified as fibers and/or plastics Class I Baxter Healthcare Corp.
Jul 11, 2014 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Si... Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. Class I Baxter Healthcare Corp.
Jul 10, 2014 LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers... Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of... Class I Hospira Inc.
Jul 3, 2014 Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules... Failed Impurities/Degradation Specifications: High out-of-specification results for a related com... Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Jun 27, 2014 Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), ... Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing. Class II Hospira Inc.
Jun 17, 2014 Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (15... Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible ... Class I Hospira Inc.
Jun 16, 2014 Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500... Presence of Particulate Matter: Complaints received of discolored solution identified as subvisib... Class II Baxter Healthcare Corp.
Jun 6, 2014 Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/25... Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container... Class II Hospira Inc.
May 16, 2014 Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multido... Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating i... Class II Hospira Inc.
May 12, 2014 0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, B... Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes Class I Baxter Healthcare Corp.
May 2, 2014 Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= pheny... Presence of Particular Matter: Potential glass delamination and consistent with glass particulate... Class II Fresenius Kabi USA, LLC
May 2, 2014 Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenyto... Presence of Particular Matter: Potential glass delamination and consistent with glass particulate... Class II Fresenius Kabi USA, LLC
Apr 24, 2014 Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G342... Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting ... Class II Baxter Healthcare Corp.

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.