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Browse Drug Recalls

9 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 9 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 9 FDA drug recalls.

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DateProductReasonClassFirm
Apr 15, 2020 Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-coun... cGMP Deviations Class II H J Harkins Company Inc dba Pharma Pac
Mar 6, 2020 Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-... Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement... Class II H J Harkins Company Inc dba Pharma Pac
Jan 6, 2020 Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count... CGMP Deviations: Presence of NDMA impurity detected in product. Class II H J Harkins Company Inc dba Pharma Pac
Jul 12, 2019 Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophth... CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufactur... Class II H J Harkins Company Inc dba Pharma Pac
Jun 24, 2019 Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torren... Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderi... Class II H J Harkins Company Inc dba Pharma Pac
Jun 24, 2019 Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by To... Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderi... Class II H J Harkins Company Inc dba Pharma Pac
Mar 4, 2019 Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 m... CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found ... Class II H J Harkins Company Inc dba Pharma Pac
Oct 18, 2018 GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg... Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 mont... Class II H J Harkins Company Inc dba Pharma Pac
Jul 26, 2018 Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkin... Carcinogen impurity detected in API used to manufacture drug product. Class II H J Harkins Company Inc dba Pharma Pac

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.