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 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
Reason Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength…
Reason Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength…
Reason Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength…
Reason Lack of Assurance of Sterility; bags have potential to leak
Reason Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R…
Reason Lack of Assurance of Sterility
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Reason Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Reason Lack of sterility assurance.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices…
Reason Labeling: Missing Label
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Reason CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Reason Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original…
Reason Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original…
Reason Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
Reason CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.
Reason Microbial contamination of Non-sterile Products; potential B. cepacia contamination
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