CLASS II Drug recall · Reported 10 Oct 2012 · FDA Enforcement Report
Nimodipine Capsules 30 mg recalled by Caraco Pharmaceutical
Caraco Pharmaceutical Laboratories is recalling Nimodipine Capsules 30 mg, distributed in Michigan. The recall was initiated on 21 Aug 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-003-2013
- FDA event ID
- 63031
- Recalling firm
- Caraco Pharmaceutical Laboratories, Cranbury, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Aug 2012
- FDA classified
- 3 Oct 2012
- Reported
- 10 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 21 Aug 2012 | Recall initiated by company | |
| 3 Oct 2012 | Classified by FDA | +43 days |
| 10 Oct 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Crystallization: Presence of crystals of Nimodipine within the capsule solution.
Product as listed by the FDA
Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202 Affiliate of Sun Pharmaceutical Industries, Inc.
Where it was distributed
One direct account - Caraco Pharmaceutical Labroatories, LTD Detroit, Michigan 78 sub accounts
Questions about this recall
Why was it recalled?
Crystallization: Presence of crystals of Nimodipine within the capsule solution.
Which lots are affected?
Lot: a) 3305.039B, Exp 07/13; b) 3305.039A, Exp 07/13
Where was it sold?
One direct account - Caraco Pharmaceutical Labroatories, LTD Detroit, Michigan 78 sub accounts
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.
More recalls from Caraco Pharmaceutical Laboratories
All 12Other Nimodipine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nimodipine Capsules 30 mg recalled by Sun Pharmaceutical Industries | Sun Pharmaceutical Industries | Other | Nationwide |