CLASS II Drug recall · Reported 17 Jul 2013 · FDA Enforcement Report
Nimodipine Capsules 30 mg recalled by Sun Pharmaceutical Industries
Sun Pharmaceutical Industries is recalling Nimodipine Capsules 30 mg, distributed nationwide in the US. The recall was initiated on 21 May 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-687-2013
- FDA event ID
- 65501
- Recalling firm
- Sun Pharmaceutical Industries, Cranbury, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 May 2013
- FDA classified
- 8 Jul 2013
- Reported
- 17 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 21 May 2013 | Recall initiated by company | |
| 8 Jul 2013 | Classified by FDA | +48 days |
| 17 Jul 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Crystallization; crystallized nimodipine
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
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Crystallization; crystallized nimodipine
Which lots are affected?
Lot #s: a) 3305.036B, 3305.037B, Exp Jun-13; 3505.041B, Exp Sep-13; 3305.043B, Exp Nov-13; 3305.044B, Exp Dec-13; 3305.045B Mar-14. Lot #s: b) 3305.036A, 3305.037A, Exp Jun-13; 3305.038A, Exp Jul-13; 3305.040A, 3505.041A Exp Sep-13; 3305.042A, 3305.043A, Exp Nov-13; 3305.044A Dec-13.
Where was it sold?
Nationwide and Puerto Rico
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.
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Other Nimodipine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nimodipine Capsules 30 mg recalled by Caraco Pharmaceutical | Caraco Pharmaceutical Laboratories | Other | MI |