CLASS III Drug recall · Reported 6 Jul 2016 · FDA Enforcement Report
Benzphetamine Hydrochloride Tablets, 50 mg recalled by KVK-Tech
Kvk-Tech is recalling Benzphetamine Hydrochloride Tablets, 50 mg, distributed nationwide in the US. The recall was initiated on 5 May 2016 and the FDA has classified it as Class III.
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-1057-2016
- FDA event ID
- 74086
- Recalling firm
- Kvk-Tech, Newtown, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 May 2016
- FDA classified
- 28 Jun 2016
- Reported
- 6 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 5 May 2016 | Recall initiated by company | |
| 28 Jun 2016 | Classified by FDA | +54 days |
| 6 Jul 2016 | 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
Discoloration: presence of scuffing marks on tablets.
Product as listed by the FDA
Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by: KVK-TECH, INC., Newtown, PA 18940, NDC 10702-0040-03
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Discoloration: presence of scuffing marks on tablets.
Which lots are affected?
Lot #: 12825 A, 12937A, Exp 8/18
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Kvk-Tech
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phentermine Hydrochloride Capsules, USP 30mg recalled by KVK TechPhentermine Hydrochloride | KVK Tech | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Indomethacin Extended-Release Capsules USP, 75 mg recalled by KVK TechIndomethacin | KVK Tech | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Betaxolol Tablets, USP 10 mg recalled by KVK-TechBetaxolol Hydrochloride | Kvk-Tech | Other | Nationwide |
| Drug | CLASS I | Atovaquone Oral Suspension, USP, 750 mg recalled by KVK-TechAtovaquone Oral Suspension | Kvk-Tech | Temperature Abuse | Nationwide |
| Drug | CLASS III | Hydrocodone Bitartrate and Homatropine Methlybromide recalledHydrocodone Bitartrate And Homatropine Methylbromide | Kvk-Tech | Potency & Assay | Nationwide |
Other Benzphetamine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Benzphetamine tablets, 50mg, CIII recalled by Calvin Scott & Company | Calvin Scott | Packaging Defects | GA |