The Recall Desk

Manufacturer

SigmaPharm Laboratories LLC

5 recalls in our database name SigmaPharm Laboratories LLC as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2021-10-06

Of the 5 recalls from SigmaPharm Laboratories LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–5 of 5

  • ModerateFDA (Drugs)·D-0898-2021·2021-10-06

    Sodium Phenylbutyrate Powder Recalled for Impurity Specification Failures

    SigmaPharm Laboratories is recalling Sodium Phenylbutyrate Powder due to failed impurity and degradation specifications detected during routine testing. The affected lots are distributed nationwide.

    Product
    Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in case packs containing 2 bottles. Sigmapharm Laboratories, LLC, Bensalem, PA 19020, NDC 42794-086-14
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0766-2021·2021-09-01

    Sodium Phenylbutyrate Powder Recalled for Failed Impurities Specifications

    SigmaPharm Laboratories is recalling Sodium Phenylbutyrate powder nationwide due to out-of-specification impurity results found during routine testing. Affected bottles have specific lot numbers and expiration dates ranging from May 2023 to May 2024.

    Product
    Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1344-2014·2014-05-28

    SigmaPharm Recalls Liothyronine Sodium Tablets Due to Cross-Contamination

    SigmaPharm is recalling four lots of Liothyronine Sodium Tablets 5 mcg due to potential cross-contamination with trace amounts of a previously manufactured product.

    Product
    LIOTHYRONINE SODIUM — LIOTHYRONINE SODIUM (LIOTHYRONINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide