CLASS II Drug recall · Reported 4 Sep 2013 · FDA Enforcement Report
Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/ Single Dose Vial recalled
Nexus Pharmaceuticals is recalling Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/ Single Dose Vial, distributed nationwide in the US. The recall was initiated on 1 Aug 2013 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-925-2013
- FDA event ID
- 65853
- Recalling firm
- Nexus Pharmaceuticals, Vernon Hills, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Aug 2013
- FDA classified
- 27 Aug 2013
- Reported
- 4 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 1 Aug 2013 | Recall initiated by company | |
| 27 Aug 2013 | Classified by FDA | +26 days |
| 4 Sep 2013 | 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
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.
Product as listed by the FDA
Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Vial, Rx only, Manufactured in the USA for Nexus Pharmaceuticals Inc, Lincolnshire, IL 60069, NDC 14789-300-02
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.
Which lots are affected?
a) Lot: 112911, Exp. 11/13, b) Lot: 030712, Exp. 3/14
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 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.
Other Benztropine recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Benztropine Mesylate Tablets, USP in all pack sizes recalled | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Benztropine Mesylate Injection, USP, 2 mg/ (1 mg/ Single Dose Vial recalledBenztropine Mesylate | Fresenius Kabi USA | Particulate Matter | Nationwide |