Boehringer Ingelheim Roxane Recalls Azathioprine Tablets Due to Incorrect Expiration Dates
Boehringer Ingelheim Roxane Inc is recalling 8,304 bottles of Azathioprine Tablets USP, 50 mg, because they were labeled with 36-month expiration dates instead of the approved 24 months.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling error regarding expiration dates.
Plain-English summary
Boehringer Ingelheim Roxane Inc is recalling 8,304 bottles of Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only (NDC 0054-4084-25). The affected product is identified by Lot 261983A with an expiration date of 11/15. The recall is being conducted because the product was labeled with 36-month expiration dates instead of the filed 24 months.
The recall is classified as Class III by the U.S. Food and Drug Administration. This classification indicates that use of, or exposure to, the violative product is not likely to cause adverse health consequences. The distribution pattern for this recall is nationwide.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on alternative treatments or replacements. The recall is limited to the specific lot and expiration date listed above.
The recalled product
- Product
- Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25
- Manufacturer
- Boehringer Ingelheim Roxane Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 8,304
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 (1)
- Lot 261983A Exp.11/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Boehringer Ingelheim Roxane Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Boehringer Ingelheim Roxane Inc
See all →- ModerateBoehringer Ingelheim Roxane Recalls Furosemide Tablets Due to CGMP Deviations
FDA (Drugs) · 2015-10-21
- ModerateBoehringer Ingelheim Roxane Recalls Furosemide Tablets Due to Manufacturing Error
FDA (Drugs) · 2015-10-21
- ModerateBoehringer Ingelheim Recalls Defective Combivent Respimat Inhalers
FDA (Drugs) · 2015-08-05
- ModerateBoehringer Ingelheim Roxane Recalls Subpotent Acarbose Tablets
FDA (Drugs) · 2015-06-03
- LowOxycodone Hydrochloride Oral Solution Recalled for Stability Failure
FDA (Drugs) · 2014-08-06
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