CLASS II Drug recall · Reported 4 Jul 2012 · FDA Enforcement Report
Mefloquine HCL Tablets, 250 mg recalled by Teva Pharmaceuticals USA
Teva Pharmaceuticals USA is recalling Mefloquine HCL Tablets, 250 mg per, distributed nationwide in the US. The recall was initiated on 2 Apr 2012 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-1396-2012
- FDA event ID
- 61664
- Recalling firm
- Teva Pharmaceuticals USA, Sellersville, PA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Apr 2012
- FDA classified
- 26 Jun 2012
- Reported
- 4 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 2 Apr 2012 | Recall initiated by company | |
| 26 Jun 2012 | Classified by FDA | +85 days |
| 4 Jul 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight.
Product as listed by the FDA
Mefloquine HCL Tablets, 250 mg, 5 tablets per blister pack; 5 Blister packs per carton, Rx only, Teva Pharmaceuticals USA Sellersville, PA 18960, Individual blister pack: NDC 0555-0171-88, 25 Unit-Dose Tablets (5x5) Carton: NDC 0555-0171-78
Where it was distributed
Nationwide
Questions about this recall
Is Mefloquine HCL Tablets, 250 mg per recalled?
Yes. Teva Pharmaceuticals USA recalled Mefloquine HCL Tablets, 250 mg per on 2 Apr 2012. The recall is Class II and its status is Terminated. Recall number D-1396-2012.
Why was it recalled?
Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight.
Which lots are affected?
Lot # 34000741A; Expiration date: 7/2013
Where was it sold?
Nationwide
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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