Browse Drug Recalls

1,317 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,317 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 1,317 FDA drug recalls in IL.

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DateProductReasonClassFirm
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...
Sep 3, 2015 Sermorelin 9 mg/10 mL SUB-Q* Injection, packaged in a) 3 mL, b) 5 mL, c) 6 m... 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 U/ LIDO 0.2%/mL Injection, packaged in a) 3 mL and b) 8 mL vials, Rx... 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 Testosterone Cypionate 200 mcg/mL in Sesame Oil Injection, packaged a) 5 mL a... 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 BIMIX INJ 30 mg-1 mg/mL Injection, 5 mL vials, Rx only, Essential Wellness PH... 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 Testosterone Cypionate 50 mg/mL Injection, 1 mL vials, Rx only, Essential Wel... 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 5000 mcg/mL Preservative Free Injection, packaged in a) 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 Cyclosporin 0.1% Opth Solution, 10 mL dropper bottles, Rx only, Essential Wel... 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 17-Alpha Hydroxyprogesterone 250 mg/mL in Sesame Oil Injection, 5 mL vials, R... 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 17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection, 5 mL vials, R... 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 Sermorelin 1000 mcg/mL SUB-Q* Injection, packaged in a) 3 mL, b) 6mL, c) 7.5m... 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 25 mg/mL PF Injection, 0.5 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 #4 (27 mg-1.5 mg-50 mcg/mL) Injection, 5 mL vials, Rx only, Essential ... 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 #2 (24 mg-0.8 mg-20 mcg /mL) Injection, 5 mL vials, Rx only, Essential... 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 Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PH... 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 20 mg/mL PF Injection, 0.05 mL prefilled syringes, Rx only, E... 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 Progesterone 100 mg/mL Ethyl Oleate Injection, 10 mL vials, Rx only, Essentia... 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 Dexamethasone 0.4% Opth Ointment, 3.5 g ointment tubes, Rx only, Essential We... 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 QUAD MIX (30 mg-1 mg-20 mcg-0.16 mg / mL) Injection, 5.2 mL vials, Rx only, E... 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 Injection, packaged in a) 2 mL, b) 12 mL, c) 15 mL, or d) 30 mL vials,... 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 #3 (24 mg-1 mg-20 mcg/mL) Injection, 5 mL vials, Rx only, Essential We... 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 sermorelin 1000 mcg/mL / LIDO 0.2% Injection, 6 mL vials, Rx only, Essential ... 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 5000 Units/mL Injection, 0.4 mL vials, Rx only, Essential Wellness PHARMA... 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 2000 Units/mL Injection, packaged in a) 4 mL and b) 15 mL vials, Rx only,... 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 Testosterone CYP/ENAN/PROP Injection in Cottonseed Oil, 66.6 mg/66.6. mg/66.6... 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 MIC Injection, 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. Uni... 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 Testosterone Cypionate 200 mcg/mL in Corn Oil Injection, 5 mL vials, Rx only,... 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 Testosterone CYP/ENAN/PROP Injection, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials... 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 Progesterone 100 mg/mL IM* Injection in Sesame Oil, 10 mL vials, Rx only, Ess... 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 DUAL TEST CYP/ENA 1:1 200 mg/mL Injection, packaged in a) 5 mL and b) 100 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 Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential ... Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is... Class II Kalman Health & Wellness, Inc. dba Essential We...
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 21, 2015 Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone ... Defective Container: Product missing safety seal around the neck of the bottle. The product labe... Class III Akorn, Inc.
Aug 20, 2015 RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lak... Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known im... Class III Akorn, Inc.
Aug 20, 2015 Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose... Defective Container: There were customer complaints of cracked and leaking glass vials. Class II Hospira 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.