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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
Oct 6, 2014 Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop ... Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. Class II Hospira Inc.
Oct 6, 2014 Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patie... Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. Class I Hospira Inc.
Oct 3, 2014 Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-... Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as... Class II Sagent Pharmaceuticals Inc
Oct 1, 2014 Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a)... Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials th... Class II Hospira Inc.
Sep 29, 2014 DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, ... Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during t... Class II Baxter Healthcare Corp.
Sep 15, 2014 CREON (pancrelipase) Delayed-Release Capsules, Lipase 24,000 USP Units, 250 C... Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000. Class II AbbVie Inc
Sep 15, 2014 Tarceva (erlotinib) Tablets, 150 mg, 30 count bottle, Rx only, Manufactured ... Failed Dissolution Specifications: The product did not meet the acceptance criteria for the disso... Class II Astellas Pharma US Inc
Sep 11, 2014 HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.... Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between ... Class I Hospira Inc.
Sep 9, 2014 Buprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10 Carpuj... Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine... Class II Hospira Inc.
Sep 8, 2014 Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq... Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride inject... Class II Baxter Healthcare Corp
Sep 4, 2014 Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Fre... Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown,... Class II Hospira Inc.
Aug 27, 2014 Dihydroergotamine mesylate 1 mg/mL injection solution packaged in an amber gl... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Nalbuphine 10 mg/mL injection solution 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 Fentanyl/bupivacaine 3000 mcg/30 mg/mL injectable packaged in 30 mL or 60 mL ... 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, 15 mg/0.5 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostad... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Bacteriostatic water for injection 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 Prednisolone acetate 50 mg/mL injectable packaged in an amber glass injectabl... 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 T106, 30 mg/1 mg/25 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 Bupivacaine hydrochloride 0.25% injectable packaged in an amber glass injecta... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Triamcinolone acetonide (PF) 40 mg/mL injection suspension packaged in an amb... 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 2% (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/bupivacaine (PF) 0.5 mg/0.2 mg/mL injectable packaged in 30 mL ... 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 T25, 4.413 mg/0.145 mg/1.475 mcg/mL (papaverine, phentolamine mesylat... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Calcium chloride (PF) 100 mg/mL injectable packaged in an amber glass injecta... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Cyclosporine/corn oil stock vehicle oil 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 Histamine 2.75 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 Cefazolin forte 25 mg/mL opthalmic solution packaged in an opaque squeeze bot... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Chlorhexidine gluconate 0.02% opthalmic solution packaged in an opaque squeez... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Pilocarpine (PF) 0.25% opthalmic solution packaged in an opaque squeeze bottl... 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/2 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 Tri-mix, 12 mg/1 mg/9 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 Tri-mix ST9-A, 30 mg/2 mg/80 mcg/mL (papaverine, phentolamine mesylate, alpro... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Hydroxocobalamin 5 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 PGE 1, 40 mcg/mL injectable packaged in a clear glass injectable vial, Martin... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915... Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages test... Class II Sage Products Inc
Aug 27, 2014 Lidocaine 2% injectable packaged in an amber glass injectable vial, 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 Diazepam 5 mg/mL injectable packaged in an amber glass injectable vial, Marti... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Cefazolin forte 50 mg/mL opthalmic solution packaged in an opaque squeeze bot... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Cyanocobalamin 1000 mcg/mL injectable solution packaged in an amber glass inj... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 PGE 2, 100 mcg/mL injectable packaged in a clear glass injectable vial, Marti... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Acetylcysteine 10% opthalmic solution packaged in an opaque squeeze bottle ey... 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/2 mg/10 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 Cyclosporine 200 mg/mL opthalmic suspension packaged in an amber glass inject... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Polyhexamethylene biguanide 0.02% opthalmic solution packaged in an opaque sq... 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 1, 12 mg/1 mg/10 mcg/0.15 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 Trimethoprim/sulfadiazine excipient stock solution injection packaged in an a... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Polyhexamethylene biguanide 2% stock solution packaged in an opaque squeeze b... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Acetylcysteine 20% (PF) inhalant solution packaged in either a 3 mL or 7 mL v... 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/0.5 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostad... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.
Aug 27, 2014 Paraben water for injection packaged in a sterile 1000 mL clear bottle, Marti... Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of ... Class II Martin Avenue Pharmacy, Inc.

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.