Acetaminophen Oral Suspension, 160 mg/5 mL recall — FDA D-0094-2022
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,685 detailed records are currently available in this category.
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin…
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Presence of Particulate Matter: Identified as Glass Particles
Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.
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