Home / Brands / SigmaPharm Laboratories
SigmaPharm Laboratories Recalls
5 recalls on record · May 28, 2014 to October 6, 2021 · Drugs
Recalls by year
14
21
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 6, 2021DrugsFDA
SigmaPharm Laboratories LLC recalls Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton
Hazard: Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
September 1, 2021DrugsFDA
SigmaPharm Laboratories LLC recalls Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-1
Hazard: Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
May 26, 2021DrugsFDA
SigmaPharm Laboratories LLC recalls Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794
Hazard: Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
May 26, 2021DrugsFDA
SigmaPharm Laboratories LLC recalls Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-
Hazard: Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
May 28, 2014DrugsFDA
SigmaPharm Laboratories LLC recalls Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 and b) 1000-count bottle NDC 42794
Hazard: Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product.