The Recall Desk

Manufacturer

Nostrum Laboratories, Inc.

8 recalls in our database name Nostrum Laboratories, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
8
Critical
0
Severe
4
Most recent
2025-08-06

Of the 8 recalls from Nostrum Laboratories, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (50%) 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.

1–8 of 8

  • ModerateFDA (Drugs)·D-0547-2025·2025-08-06

    Sucralfate tablets recalled because bankruptcy left the quality program unmonitored

    Sucralfate Tablets USP 1 gram from Nostrum Laboratories are being recalled across all lots within expiry because the firm cannot monitor its quality program after filing for Chapter 11. 60,608 bottles affected.

    Product
    Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0249-2021·2021-02-10

    Nostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Nostrum Laboratories is recalling 7,071 bottles of Metformin Hydrochloride Extended-Release Tablets, 750 mg, because the product contains N-Nitrosodimethylamine (NDMA) above acceptable levels.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120. NDC: 29033-056-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0227-2021·2021-01-20

    Nostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Nostrum Laboratories is recalling Metformin Hydrochloride Extended-Release Tablets, 750 mg, because the product contains N-Nitrosodimethylamine (NDMA) above acceptable intake levels.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC: 29033-056-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0067-2021·2020-11-11

    Nostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Nostrum Laboratories is recalling Metformin Hydrochloride Extended-Release Tablets 750 mg because the NDMA impurity level exceeds acceptable intake limits.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0068-2021·2020-11-11

    Nostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Nostrum Laboratories is recalling 20,872 bottles of Metformin Hydrochloride Extended-Release Tablets 500 mg because they contain N-Nitrosodimethylamine (NDMA) above acceptable levels.

    Product
    Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1059-2020·2020-04-01

    Nostrum Recalls Theophylline Tablets Due to Incorrect Lot and Expiration Dates

    Nostrum Laboratories is recalling Theophylline Extended-Release Tablets because poor manufacturing practices resulted in incorrect lot and expiration date labeling.

    Product
    Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC 29033-001-01.
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Drugs)·D-0473-2018·2018-02-28

    Nostrum Recalls Calcium Acetate Capsules Due to Foreign Material Presence

    Nostrum Laboratories is recalling Calcium Acetate Capsules because foreign tablets or capsules were found in the product.

    Product
    Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufactured by Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-026-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1030-2016·2016-06-22

    Nostrum Recalls Nitrofurantoin Oral Suspension for Failed Dissolution Specifications

    Nostrum Laboratories is recalling Nitrofurantoin Oral Suspension because it failed to meet dissolution specifications. The recall covers 2,839 bottles distributed nationwide.

    Product
    Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Mfg. by: Sun Pharmaceutical Industries, Inc., Bryan, Ohio 43506, NDC 57664-239-32
    Category
    Drug
    Distribution
    Distributed nationwide