Browse Drug Recalls

2,151 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,151 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 2,151 FDA drug recalls.

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DateProductReasonClassFirm
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
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 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 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 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 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 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 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 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 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 13, 2019 Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only,... GMP Deviations; possible cross contamination of product due to cleaning procedure failure. Class II American Health Packaging
May 13, 2019 Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per bliste... GMP Deviations; possible cross contamination of product due to cleaning procedure failure. Class II American Health Packaging
May 13, 2019 Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per bliste... GMP Deviations; possible cross contamination of product due to cleaning procedure failure. Class II American Health Packaging
May 13, 2019 Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blis... GMP Deviations; possible cross contamination of product due to cleaning procedure failure. Class II American Health Packaging
May 11, 2019 Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by:... Cross Contamination with Other Products: product is being recalled due to possible cross-contamin... Class I Novartis Pharmaceuticals Corp.
May 9, 2019 Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Onl... GMP Deviations: Potential cross contamination due to cleaning procedure failure. Class II American Health Packaging
May 9, 2019 Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count... GMP Deviations: Potential cross contamination due to cleaning procedure failure. Class II American Health Packaging
May 6, 2019 Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactu... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: ... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manu... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Ma... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila ... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactu... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufa... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufac... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: ... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: C... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufac... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 6, 2019 MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by:... CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class II Zydus Pharmaceuticals USA Inc
May 2, 2019 DrKids Children's Natural Cough Syrup English Ivy Leaf Organic Agave Nectar P... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
May 2, 2019 DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guai... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
May 2, 2019 CVS Health Children's Mucus Relief Chest Congestion Plus Cough Dextromethorph... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
May 2, 2019 CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
May 2, 2019 CVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief Natural Pin... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
May 2, 2019 CVS Health Children's Nasal Saline Drops With Himalayan Salt Saline Nasal Moi... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
May 2, 2019 DrKids Himasal Natural Nasal Saline Solution with Himalayan Salt, 20 count Si... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.

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.