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Browse Drug Recalls

11 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 11 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 11 FDA drug recalls.

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DateProductReasonClassFirm
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 6, 2019 Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceutica... Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported Class II Geritrex, LLC
May 6, 2019 Senna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Ger... Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported Class II Geritrex, LLC
May 7, 2018 Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical 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.