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Moderate riskFDA DrugClass II

Sun Pharmaceutical lisdexamfetamine recalled for failed dissolution

Sun Pharmaceutical Industries is recalling 17,760 bottles of lisdexamfetamine dimesylate capsules 40 mg, 100-count, because they failed dissolution specifications. The bottles were distributed in Ohio and Mississippi. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Sun Pharmaceutical recalls

What to do

  1. Talk to your pharmacist or prescriber before stopping this medicine.
  2. Check whether your bottle is NDC 57664-049-88 with lot AD97036 (exp. 06/30/2027) or lot AE05842 (exp. 09/30/2027).
  3. The notice doesn't say how to get a refund or replacement; ask your pharmacy where you got the medicine.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Lisdexamfetamine Dimesylate Capsules 40 mg, 100-count bottle, Rx Only, Manufactured by: Ohm Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 57664-049-88.
Sold in
OHIO and Mississippi
Made for
All ages (0 months and older)

Details

Units affected
17,760 bottles
Illnesses reported
None reported
Manufactured in
2 Independence Way, Princeton, New Jersey, United States
Classification
Class II
Recall number
D-0174-2027

In the FDA's words

Description
Lisdexamfetamine Dimesylate Capsules 40 mg, 100-count bottle, Rx Only, Manufactured by: Ohm Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 57664-049-88. Failed Dissolution Specifications Lot#: AD97036; Exp. 06/30/2027 Lot#: AE05842; Exp. 09/30/2027 Distribution: OHIO and Mississippi Affected quantity: 17,760 bottles
Hazard
Failed Dissolution Specifications

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