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Browse Drug Recalls

1,681 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,681 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 1,681 FDA drug recalls in 2018.

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DateProductReasonClassFirm
Jun 12, 2018 MORphine 1 mg/mL (Morphine Sulfate, USP 100mg, 0.9% Sodium Chloride, USP QS 1... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg, 0.9% Sodium Chloride (U... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 fentaNYL 3 mcg/mL, 0.1% Bupivacaine, Fentanyl Citrate, USP 750 mcg, Bupivacai... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 MAGnesium 4gm in NS 100 mL (MAGnesium SULfate (USP) 4 gm, 0.9% Sodium Chlorid... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodiu... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 fentaNYL 2 mcg/mL, 0.125% ROPivacaine, Fentanyl Citrate, USP 300 mcg, Ropiva... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 NORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg, 5% Dextrose Inj. (U... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg, 0.9% Sodium Chlor... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 ePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 5% Dextrose ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 HYDROmorphone 0.2mg/mL. (Hydromorphone HCL (USP) 20 mg, 0.9% Sodium Chloride ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 Midazolam 1 mg/mL (Midazolam HCL (USP) 55 mg, 0.9% Sodium Chloride, (USP) QS... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 Vancomycin 1.25gm in D5W 250 mL. ( Vancomycin HCL (USP) 1.25 gm, 5% Dextrose ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 EPINEPHrine (USP) 4 mg, 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL sing... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 11, 2018 Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application... CGMP Deviations: Products not manufactured under current good manufacturing practices. Class II BioDiagnostic International
Jun 8, 2018 ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualge... Labeling: Incorrect or Missing Lot and/or Exp Date. Class III Qualgen, LLC
Jun 8, 2018 Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Sin... Superpotent Drug: High out of specification assay value results for potency. Class II Ingenus Pharmaceuticals Llc
Jun 8, 2018 TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Q... Labeling: Incorrect or Missing Lot and/or Exp Date. Class III Qualgen, LLC
Jun 8, 2018 Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Sing... Superpotent Drug: High out of specification assay value results for potency. Class II Ingenus Pharmaceuticals Llc
Jun 7, 2018 Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 m... Superpotent Drug: Composite assay results obtained during routine stability testing were slightly... Class III Mylan Pharmaceuticals Inc.
Jun 6, 2018 Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, pa... Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility. Class II Pharmalucence, Inc.
Jun 5, 2018 HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in... Superpotent and Subpotent Class II PharMEDium Services, LLC
Jun 4, 2018 Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Si... Presence of Particulate Matter; Potential for particulate matter on the syringe plunger. Class I HOSPIRA INC, LAKE FOREST
May 31, 2018 0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake ... Lack of assurance of sterility: Bags have potential to leak. Class II ICU Medical Inc
May 31, 2018 5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, I... Lack of assurance of sterility: Bags have potential to leak. Class II ICU Medical Inc
May 31, 2018 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake ... Lack of assurance of sterility: Bags have potential to leak. Class II ICU Medical Inc
May 31, 2018 Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray... Presence of foreign substance: glass particles Class II Apotex Inc.
May 31, 2018 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake ... Lack of assurance of sterility: Bags have potential to leak. Class II ICU Medical Inc
May 31, 2018 0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake... Lack of assurance of sterility: Bags have potential to leak. Class II ICU Medical Inc
May 30, 2018 Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr.... Presence of Foreign Substance: A product complaint was received for a defective tablet with an em... Class II Dr. Reddy's Laboratories, Inc.
May 29, 2018 Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Onl... Resuspension problems: Out of specification for appearance and resuspendability. Class III Pharmaceutical Associates Inc
May 25, 2018 X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC... CGMP Deviations: products may be contaminated with bacteria. Class II Shadow Holdings DBA Bocchi Labs
May 25, 2018 Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant ... Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a... Class III Jubilant Cadista Pharmaceuticals, Inc.
May 25, 2018 Acne Shave 3 Step Shaving System, contains one tube Acne Shave (salicylic aci... CGMP Deviations: products may be contaminated with bacteria. Class II Shadow Holdings DBA Bocchi Labs
May 25, 2018 Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5%, 3.3 FL OZ (98 mL) t... CGMP Deviations: products may be contaminated with bacteria. Class II Shadow Holdings DBA Bocchi Labs
May 25, 2018 Acne Shave (salicylic acid) Shave Cream Acne Shield, 0.5%, 5.1 FL OZ (150 mL)... CGMP Deviations: products may be contaminated with bacteria. Class II Shadow Holdings DBA Bocchi Labs
May 24, 2018 Allergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians... Contraceptive Tablets Out of Sequence. Class I Allergan, PLC.
May 24, 2018 Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-coun... Labeling: Missing Label Class III LUPIN SOMERSET
May 22, 2018 READYFLUSH PROTECT with Dimethicone (3.2%), Flushable Personal Cleaning Cloth... Microbial Contamination of a Non-Sterile Product. Class II Medline Industries Inc (Northpoint Services)
May 17, 2018 Methylene Blue 10 mg/mL 1ml. Packaged in 1 mL syringes. Compounded Guardian P... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Glutathione 200 mg/mL 100ml. Rx Only. Packaged in 100 mL MDV vials. Compounde... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100 ml vial. Comp... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 7K capsules packaged in single packs sold in 24-count boxes, Distributed by S... Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenaf... Class I Shoreside Enterprises Inc.
May 17, 2018 Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL syringes. Refridger... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV vials. Compounded... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml bag. Compound... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL vials. Compounde... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials. Compounded Guardi... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD 25 ml. Comp... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 MIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial. Compounded Guard... Lack of sterility assurance. Class II Guardian Pharmacy Services

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.