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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to labeling errors (incorrect lot and expiration dates) resulting from poor manufacturing practices, which fits the rubric for minor labeling errors or low-risk contamination without reported illness.
Plain-English summary
Nostrum Laboratories, Inc. is recalling Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottles. The recall involves 4,722 bottles of the prescription medication, identified by Lot THE190501 and an expiration date of 11/2022. The product was distributed in Tennessee and Missouri.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Poor manufacturing practices resulted in the product being incorrectly labeled with the wrong lot and expiration date. This labeling error is classified as an FDA Class II recall.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative medication. The recalled product is identified by NDC 29033-001-01.
The recalled product
- 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.
- Manufacturer
- Nostrum Laboratories Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 4,722
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: THE190501
- Exp 11/2022
Distribution
Related recalls
Same manufacturer · Nostrum Laboratories Inc
See all →- ModerateSucralfate tablets recalled because bankruptcy left the quality program unmonitored
FDA (Drugs) · 2025-08-06
- SevereNostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
FDA (Drugs) · 2021-02-10
- SevereNostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
FDA (Drugs) · 2021-01-20
- SevereNostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
FDA (Drugs) · 2020-11-11
- SevereNostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
FDA (Drugs) · 2020-11-11
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02