The Recall Desk

Manufacturer

Boehringer Ingelheim Roxane Inc

15 recalls in our database name Boehringer Ingelheim Roxane Inc as the manufacturing or recalling firm.

What the numbers show

Total
15
Critical
0
Severe
1
Most recent
2015-10-21

Of the 15 recalls from Boehringer Ingelheim Roxane Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (7%) 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.

1–15 of 15

  • ModerateFDA (Drugs)·D-1279-2015·2015-08-05

    Boehringer Ingelheim Recalls Defective Combivent Respimat Inhalers

    Boehringer Ingelheim is recalling 358,647 Combivent Respimat inhalers because the delivery system may fail to spray properly.

    Product
    COMBIVENT RESPIMAT — COMBIVENT RESPIMAT (IPRATROPIUM BROMIDE AND ALBUTEROL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1085-2015·2015-06-03

    Boehringer Ingelheim Roxane Recalls Subpotent Acarbose Tablets

    Boehringer Ingelheim Roxane Inc is recalling Acarbose 50 mg tablets because potency was below specification at a 9-month stability time point.

    Product
    ACARBOSE — ACARBOSE (ACARBOSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1486-2014·2014-08-06

    Oxycodone Hydrochloride Oral Solution Recalled for Stability Failure

    Boehringer Ingelheim Roxane Inc is recalling 2,149 vials of Oxycodone Hydrochloride Oral Solution due to out-of-specification preservative levels.

    Product
    OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx only. Boehringer Ingelheim, Roxane Laboratories. Roxane Laboratories, Inc. Columbus, Ohio 43216. NDC: 0054-0523-41.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1313-2014·2014-05-14

    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.

    Product
    Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-343-2014·2013-12-18

    Oxcarbazepine Tablets Recalled for Potential Subpotency

    Boehringer Ingelheim Roxane Inc. is recalling Oxcarbazepine Tablets, 150 mg, due to out-of-specification assay results and potential lower weight tablets.

    Product
    Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) 100-count bottle (NDC 0054-0097-25), Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-002-2014·2013-11-27

    Boehringer Ingelheim Recalls Oxcarbazepine Oral Suspension Due to Resuspension Issues

    Boehringer Ingelheim is recalling 10,267 bottles of Oxcarbazepine Oral Suspension because the product failed to meet resuspendability requirements.

    Product
    Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-126-2013·2013-01-23

    Boehringer Ingelheim Recalls Perindopril Erbumine Tablets Due to Impurity

    Boehringer Ingelheim Roxane Inc. is recalling 3,553 bottles of Perindopril Erbumine Tablets, 8mg, because out-of-specification results were found for impurity B.

    Product
    Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-067-2013·2012-12-05

    Boehringer Ingelheim Recalls Pradaxa 75 mg Capsules Due to Defective Containers

    Boehringer Ingelheim is recalling 8,381 bottles of Pradaxa 75 mg capsules because defective containers may allow moisture to enter, potentially impairing product quality.

    Product
    Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54
    Category
    Drug
    Distribution
    Distributed nationwide