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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
May 4, 2016 OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose... Failed Impuities/Degradation Specifications Class II Fresenius Kabi USA, LLC
May 4, 2016 OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose... Failed Impuities/Degradation Specifications Class II Fresenius Kabi USA, 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 22, 2016 Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bot... Labeling: Not elsewhere classified - count on the label was incorrect. Class III A-S Medication Solutions LLC.
Apr 12, 2016 Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium... Discoloration: presence of atypical yellow discoloration of the solution . Class II Baxter Healthcare Corp.
Apr 7, 2016 Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi... Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of... Class III 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.
Apr 5, 2016 Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intraven... Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Pres... Class II Fresenius Kabi USA, LLC
Mar 24, 2016 Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for Abb... Failed Content Uniformity Specifications Class III AbbVie Inc.
Mar 23, 2016 Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, ... Failed pH Specifications: Confirmed high out of specification (OOS) results for pH. Class III Hospira Inc.
Mar 23, 2016 ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (47... Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) ... 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 23, 2016 PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. ... Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) ... Class II Akorn, Inc.
Mar 23, 2016 Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PE... Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) ... Class II Akorn, 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 15, 2016 Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL ... Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiratio... Class III Hospira Inc.
Mar 8, 2016 Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, In... Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ... Class II Hospira Inc.
Mar 8, 2016 Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx on... Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ... Class II Hospira Inc.
Mar 8, 2016 Dextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag, Rx only, Ho... Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ... Class II Hospira Inc.
Mar 8, 2016 Dextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hos... Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ... Class II Hospira Inc.
Mar 8, 2016 Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hos... Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ... Class II Hospira Inc.
Mar 8, 2016 Dextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Ho... Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ... Class II Hospira Inc.
Mar 1, 2016 Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Sing... Cross contamination with other products: metronidazole Class II Sagent Pharmaceuticals Inc
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.
Feb 2, 2016 Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection ... Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect exp... Class III Hospira Inc.
Jan 28, 2016 Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by M... Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6... Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
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... Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of ste... Class II 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.
Jan 5, 2016 Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g T... Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which ... Class I Hospira Inc.
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
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 Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottl... Super-Potent Drug: Out of Specification Assay test results were reported for stability samples. Class III Morton Grove Pharmaceuticals, Inc.
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 2, 2015 Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tabl... Failed Impurities/Degradation Specifications: Out of specification for impurities. Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Oct 29, 2015 EPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag, Rx onl... Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP mono... Class III PQ Corporation
Sep 29, 2015 Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL,... Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation p... Class III Hospira Inc.
Sep 25, 2015 ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle,... Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets misla... Class I Medline Industries Inc
Sep 25, 2015 ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottl... Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets misla... Class I Medline Industries Inc
Sep 3, 2015 Methylcobalamin 30 mg/mL PF Injection, 0.1 mL prefilled syringes, Rx only, Es... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 TRIMIX SPECIAL (30 mg-1 mg-10 mcg/mL) Injection, 5 mL vials, Rx only, Essenti... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 HCG 3000 Units/mL Injection, 2 mL vial, Rx only, Essential Wellness PHARMACY,... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 Methylcobalamin 1 mg/mL (Pres Free) Injection, 1 mL prefilled syringes, Rx on... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 Acetylcysteine 10% Oph Solution, packaged in a) 6 mL and b) 12 mL dropper bot... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 LIPO-B Special Injection,12 mL vials, Rx only, Essential Wellness PHARMACY, 4... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 TRIMIX #1 Injection, 4.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 HCG 1000 Units/mL SUB-Q Injection, packaged in a)1.5 mL, b) 2 mL, c) 2.4 mL, ... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
Sep 3, 2015 HCG 10,000 Units/mL Injection, packaged in a) 1 mL, b) 1.2 mL, c) 1.6 mL, d) ... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...

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.