Browse Drug Recalls

2,138 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,138 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 2,138 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Jun 18, 2019	Isoproterenol HCL in D5W (Non Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50m...	Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti...	Class II	Premier Pharmacy Labs Inc
Jun 18, 2019	SUCCINYLcholine Chloride, 200mg/10mL (20mg/mL), 10mL Sterile Single Dose Syri...	Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti...	Class II	Premier Pharmacy Labs Inc
Jun 18, 2019	SUCCINYLcholine Chloride, 100mg/5mL (20mg/mL), 5mL Sterile Single-Use Syringe...	Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti...	Class II	Premier Pharmacy Labs Inc
Jun 18, 2019	Neostigmine Methylsulfate, 5mg/5mL (1mg/mL), 5mL Single Dose Syringe, Rx only...	Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti...	Class II	Premier Pharmacy Labs Inc
Jun 18, 2019	Brilliant Blue Ophthalmic PF INJ, 0.5mg/mL (0.05%), 1 mL SDV, Rx only, Premie...	Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti...	Class II	Premier Pharmacy Labs Inc
Jun 18, 2019	Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Sing...	Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti...	Class II	Premier Pharmacy Labs Inc
Jun 10, 2019	Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextrometho...	CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Preferred Pharmaceuticals, Inc
Jun 5, 2019	Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free...	cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL...	Class II	P & L Developments, LLC
Jun 5, 2019	Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye ...	cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL...	Class II	P & L Developments, LLC
Jun 5, 2019	Cetirizine Oral Solution 1 mg/mL, Up & Up, Children's allergy relief, Antihis...	cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL...	Class II	P & L Developments, 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 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	Ritussin DM Double Strength, 4 FL. OZ. (118 mL), RIJ Pharmaceutical Corporati...	cGMP Deviations: Products may have microbial contamination.	Class II	Geritrex, LLC
May 31, 2019	Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), ...	cGMP Deviations: Products may have microbial contamination.	Class II	Geritrex, LLC
May 31, 2019	Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL), RIJ...	cGMP Deviations: Products may have microbial contamination.	Class II	Geritrex, LLC
May 31, 2019	Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (4...	cGMP Deviations: Products may have microbial contamination.	Class II	Geritrex, LLC
May 31, 2019	Gericare Geri-Tussin DM, 16 FL OZ (473 mL), Geri-care Phamaceuticals Corp. 16...	cGMP Deviations: Products may have microbial contamination.	Class II	Geritrex, LLC
May 31, 2019	Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 ...	cGMP Deviations: Products may have microbial contamination.	Class II	Geritrex, LLC
May 21, 2019	Biscolax Laxative (Bisacodyl, USP 10 mg), a) 12 suppositories per carton, NDC...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	Pedia Relief Cough-Cold Oral Solution, Alcohol free, antihistamine, cough sup...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	Nasal Decongestant Spray Regular, Oxymetazoline HCl 0.05%, a) 0.5 FL. oz. (15...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	Allergy Liquid Antihistamine, Diphenhydramine HCl USP 12.5 mg/5 mL), Alcohol ...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	Hyoscyamine Sulfate Elixir 0.125 mg per 5 mL, Rx Only, 473 mL (16 oz.) bottle...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	Phenobarbital Oral Solution, USP, 20 mg per 5 mL, Rx Only, One Pint (473 mL) ...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	Robafen DM Syrup (Dextromethorphan HBr, USP 20 mg/10 mL and Guaifenesin, USP ...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 mL, a) 4 FL. o...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	Robafen DM Cough Sugar-Free Clear Cough Expectorant (Dextromethorphan HBr, US...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	Bisacodyl Suppositories, Brite Stock, Reese.	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 1mg/mL, Fr Oral Use Only, Rx only...	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 Administration, Rx Only, a) 16 F...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, ...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5mL, 473 mL (16 FL...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	Pain & Fever Oral Solution (Acetaminophen 160 mg/5 mL), Sugar free, Aspirin &...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	Robafen AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, US...	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 13668-589...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	Laxative Suppositories (Bisacodyl USP, 10 mg), a) 12 Suppositories per carton...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	Hydrocortisone Acetate Suppositories, 25 mg, Rx Only, For rectal administrati...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	Children's Mapap Acetaminophen Liquid, Fever reducer, Pain reliever, Alcohol ...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	Guaifenesin DAC Oral Solution, Sugar free, (Guaifenesin, Pseudoephedrine HCl...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	Pseudoephedrine Oral Solution, 30 mg in each teaspoonful, Nasal Decongestant,...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	Acetic Acid Otic Solution, USP, 2%, Rx Only, 15 mL bottle, NDC: 64980-424-15...	cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto...	Class II	Torrent Pharma Inc
May 21, 2019	Robafen Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 mL), a) ...	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
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	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	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	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

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.