Food, drugs, devices › Sun Pharmaceutical Industries Inc.
Drug recall: Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per ca
Sun Pharmaceutical Industries Inc. (Cranbury, NJ) initiated this drug recall on 21 May 2013; FDA lists 1 product record under event 65501, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 56% of the 370 drug enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 25 Aug 2014. Initiation: voluntary: firm initiated. Sun Pharmaceutical Industries Inc. has 94 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Sun Pharmaceutical Industries Inc., Cranbury, NJ.
Reason for recall
"Crystallization; crystallized nimodipine"
Distribution
"Nationwide and Puerto Rico"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-687-2013 | 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… | 46387 Cartons | Class II | Terminated | 17 Jul 2013 |
Context
Other enforcement events for Sun Pharmaceutical Industries Inc.
All 94 events for Sun Pharmaceutical Industries Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Crystallization; crystallized nimodipine"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide and Puerto Rico"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 25 Aug 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.