Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99
USDicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99
Recalling Firm: Aurobindo Pharma USA Inc
Reason for Recall / Hazard
shortfill; reports of empty capsules.
Product Description & Identification
Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99
Additional Source Details
| Field | Value |
|---|---|
| City | East Windsor |
| State | NJ |
| Openfda › Upc | 0359651719015 |
| Openfda › Unii | CQ903KQA31 |
| Openfda › Route | ORAL |
| Openfda › Rxcui | 991061 |
| Openfda › Spl id | ec746016-eed0-4e37-bb9c-cb430c8a7f07 |
| Openfda › Brand name | DICYCLOMINE HYDROCHLORIDE |
| Openfda › Spl set id | ec746016-eed0-4e37-bb9c-cb430c8a7f07 |
| Openfda › Package ndc › 1 | 59651-719-01 |
| Openfda › Package ndc › 2 | 59651-719-99 |
| Openfda › Product ndc | 59651-719 |
| Openfda › Generic name | DICYCLOMINE HYDROCHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | DICYCLOMINE HYDROCHLORIDE |
| Openfda › Manufacturer name | Aurobindo Pharma Limited |
| Openfda › Application number | ANDA040319 |
| Openfda › Is original packager | true |
| Event id | 99492 |
| Address 1 | 279 Princeton Hightstown Rd |
| Code info | Batch # DMC125018A, Exp Date: 07/2027. |
| Postal code | 08520-1401 |
| Report date | 20260812 |
| Product type | Drugs |
| Product quantity | 6,408 bottles distributed to market |
| Reason for recall | shortfill; reports of empty capsules. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260723 |
| Initial firm notification | Letter |
| Center classification date | 20260804 |
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Overview
- Recalling FirmAurobindo Pharma USA Inc
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide.
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🚨 SAFETY ALERT: Aurobindo Pharma USA Inc - Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99 Check if your household is affected: https://therecallfile.com/recalls/dicyclomine-hydrochloride-capsules-usp-10mg-1-000-bottles-rx-only-dist/FDA-D-0733-2026
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