CLASS II Drug recall · Reported 4 Oct 2017 · FDA Enforcement Report
Acarbose Tablets, 25 mg recalled by Teva Pharmaceuticals U
Teva Pharmaceuticals U is recalling Acarbose Tablets, 25 mg, distributed nationwide in the US. The recall was initiated on 5 Sep 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1178-2017
- FDA event ID
- 78060
- Recalling firm
- Teva Pharmaceuticals U, North Wales, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Sep 2017
- FDA classified
- 28 Sep 2017
- Reported
- 4 Oct 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 5 Sep 2017 | Recall initiated by company | |
| 28 Sep 2017 | Classified by FDA | +23 days |
| 4 Oct 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is printed on the product labeling rather than the correct expiration date of July 2017.
Product as listed by the FDA
Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 16252-523-01.
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Acarbose Tablets, 25 mg recalled?
Yes. Teva Pharmaceuticals U recalled Acarbose Tablets, 25 mg on 5 Sep 2017. The recall is Class II and its status is Terminated. Recall number D-1178-2017.
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is printed on the product labeling rather than the correct expiration date of July 2017.
Which lots are affected?
Lot #: 1082710A, Exp 07/18
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Acarbose recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Acarbose Tablets 50 mg a) Unit Dose Tablets per, b) recalledAcarbose | Boehringer Ingelheim Roxane | Potency & Assay | Nationwide |