Yes — there is an active recall. 34 ongoing FDA recalls mention Amino (367 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Amino. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Reason Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain…
Reason Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say…
Reason cGMP deviations: Discolored acetaminophen
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled…
Reason Discoloration and failed pH specifications
Reason Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability…
Reason Presence of Foreign Tablet/Capsule: One bottle of Hydrocodone Bitartrate and Acetaminophen Tablets USP 10mg/325 mg contains one Losartan Potassium…
Reason Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Reason Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Reason cGMP Deviations
Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
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