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Browse Drug Recalls

1,788 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,788 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 1,788 FDA drug recalls in 2019.

Clear
DateProductReasonClassFirm
May 31, 2019 Ritussin DM Children & Adults, 4 Fl. Oz. (118 mL), RIJ Pharmaceutical Corpora... cGMP Deviations: Products may have microbial contamination. Class II Geritrex, LLC
May 31, 2019 Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 m... cGMP Deviations: Products may have microbial contamination. Class II Geritrex, LLC
May 30, 2019 Memorial Central TPN. Rx Only, Rx # specific and Patient Specific volumes. M... Lack of sterility assurance. Class II Surgery Pharmacy Services Inc
May 30, 2019 Trisodium Citrate 0.5% CRRT SOLUTION. RX Only. Rx # specific and Patient Spec... Lack of sterility assurance. Class II Surgery Pharmacy Services Inc
May 28, 2019 Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 ... Lack of Processing Controls. Class II Synthetopes Inc
May 28, 2019 Pecgen DMX Cough Suppressant Expectorant, Contains the same active ingredient... Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage informat... Class I Novis PR, Inc.
May 28, 2019 Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature,... Lack of Processing Controls. Class II Synthetopes Inc
May 28, 2019 Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection... Lack of Processing Controls. Class II Synthetopes Inc
May 28, 2019 Sn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at R... Lack of Processing Controls. Class II Synthetopes Inc
May 28, 2019 Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injectio... Lack of Processing Controls. Class II Synthetopes Inc
May 28, 2019 Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection,... Lack of Processing Controls. Class II Synthetopes Inc
May 28, 2019 Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc. Lack of Processing Controls. Class II Synthetopes Inc
May 28, 2019 Sn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc. Lack of Processing Controls. Class II Synthetopes Inc
May 23, 2019 Human Chorionic Gonadotropin 5,000 IU vials, Rx only, Pharm D. Solutions 1304... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Testosterone 200 mg/mL, 30 mL vials, Rx only, Pharm D. Solutions 1304 South L... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Human Chorionic Gonadotropin 12,000 IU vials Pharm D. Solutions 1304 South L... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Ipamorelin Acetate 9 mg/9mL Injectable vials, Rx only, Pharm D. Solutions 130... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Testosterone Cypionate 200 mg/mL, in a) 5mL vials and b)10 mL vials, Rx only,... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Sermorelin/GHRP-2 9 mg/6 mg vials, Rx only, Pharm D. Solutions 1304 South Loo... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Bacteriostatic Water for Injection, 10 mL vials, Pharm D. Solutions 1304 Sout... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Lipo MIC-12 (Methylcobalamin, USP 1mg, Methionine USP 15mg, Inositol, FCC 50m... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Trimix 30mg/1 mg/10mcg/mL ( 30 mg Papaverine, 1mg phentolamine mesylate, 30 m... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Sermorelin/GHRP-2 &6 (9-9-9-mg) vials, Pharm D. Solutions 1304 South Loop Wes... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Testosterone Cyp/Pro 95/5%, 10 mL vials, Rx only, Pharm D. Solutions 1304 S... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Sermorelin/Ipamorelin 18 mg/15 mg, 10mL vials, Rx only, Pharm D. Solutions 13... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Sermorelin/GHRP-2 &6 (9-9-9 mg) vials, Pharm D. Solutions 1304 South Loop Wes... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Sermorelin/GHRP-2 9 mg/9 mg vials Pharm D. Solutions 1304 South Loop West, Ho... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 m... Complaint received of metal piece identified in the product bottle prior to the reconstitution. Class II Lupin Pharmaceuticals Inc.
May 23, 2019 B-complex (Thiamine 100mg, Riboflavin 2mg, Niacinamide 100 mg, Pyridoxine 2mg... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Sermorelin/GHRP-2 & 6 (3-3-3 MG) vials, Pharm D. Solutions 1304 South Loop We... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Nandrolone Decanoate 200 mg/mL Injectable, 10 mL vials, Rx only, Pharm D. Sol... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Human Chorionic Gonadotropin 10,000 IU vials, Rx only Pharm D. Solutions 130... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 22, 2019 Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kab... Failed Impurities/Degradation Specifications. Class III Fresenius Kabi USA, LLC
May 21, 2019 Nasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg in each teaspoonful, 4 ... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 Kid Kare Childrens Cough/Cold Liquid, Antihistamine, Cough Suppressant, Nasal... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 Memantine Hydrochloride Oral Solution, 2 mg/mL, Rx Only, 12 FL. oz.. bottle, ... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only,... Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL ... Class I Heritage Pharmaceuticals, Inc.
May 21, 2019 Hyoscyamine Oral Drops 0.125 mg/mL, Rx Only, 15 mL bottle (0.5 FL. oz.), NDC:... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 Lactulose Solution, USP 10 g/15 mL, For Oral or Rectal Administration, Rx Onl... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 Rect... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 Children's Acetaminophen Liquid, 160 mg per 5 mL, Fever and Pain, Alcohol fre... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic ... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor, (Diphenhydra... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 ... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 23155-317... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 ... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, For Oral Use Only, Rx On... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fa... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma Inc
May 21, 2019 Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551... cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... Class II Torrent Pharma 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.