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Browse Drug Recalls

16 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 16 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 16 FDA drug recalls.

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DateProductReasonClassFirm
Sep 23, 2019 DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measu... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
Sep 23, 2019 DrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
Jul 15, 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.
Jul 15, 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.
Jul 15, 2019 DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistami... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
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.
May 2, 2019 DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistami... 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 Pain & Fever Acetaminophen 160 mg/5 mL Pain reliever/Fe... 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 & Chest Congestion DM Dextromethorphan HBr, 5 mg ... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
May 2, 2019 DrKids Children's Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL, 20 P... 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.