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Browse Drug Recalls

8 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 8 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 8 FDA drug recalls.

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DateProductReasonClassFirm
Jul 11, 2019 Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspe... Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the a... Class II Tris Pharma Inc.
Jan 15, 2019 Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 ... Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. Class II Tris Pharma Inc.
Jan 15, 2019 Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 ... Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. Class II Tris Pharma Inc.
Jan 15, 2019 infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 m... Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. Class II Tris Pharma Inc.
Nov 26, 2018 Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 ... Superpotent Drug: recalled lots may have higher concentration of ibuprofen. Class II Tris Pharma Inc.
Nov 26, 2018 Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 ... Superpotent Drug: recalled lots may have higher concentration of ibuprofen. Class II Tris Pharma Inc.
Nov 26, 2018 infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 m... Superpotent Drug: recalled lots may have higher concentration of ibuprofen. Class II Tris Pharma Inc.
Jun 15, 2017 Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. ... Defective container: Oral solution leaking from container. Class II Tris 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.