Kansas City, MO, United States
Nostrum Laboratories Inc recalls
6 recalls recorded since 2018, most recently on 11 July 2025. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)4
Terminated or completed2
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 11 July 2025
- Reason
- CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
- Distribution
- nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0547-2025
- 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.
Ongoing Class II Drugs
- Recall started
- 25 January 2021
- Reason
- CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0249-2021
- 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
Ongoing Class II Drugs
- Recall started
- 4 January 2021
- Reason
- CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0227-2021
- 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
Ongoing Class II Drugs
- Recall started
- 23 October 2020
- Reason
- CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0068-2021, D-0067-2021
- 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
- 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
Terminated Class II Drugs
- Recall started
- 6 March 2020
- Terminated
- 1 April 2022
- Reason
- CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date.
- Distribution
- TN, MO
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1059-2020
- 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.
Terminated Class III Drugs
- Recall started
- 13 February 2018
- Terminated
- 13 December 2018
- Reason
- Presence of Foreign Tablets/Capsules
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0473-2018
- Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufactured by Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-026-02
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.