Class II · Moderate risk
Methylphenidate Hydrochloride
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Methylphenidate Hydrochloride Tablets USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Dissolution Specifications: Low out of specification results for dissolution.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01.
Affected NDC
0591-5884-01
Compare with the code on your package — it is the most precise check available.
Drug: Methylphenidate
- Recalling firm
- Teva Pharmaceuticals USA
- NDC code
- 0591-5884-01
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0052-2018 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Methylphenidate recalls
See all
Class II · Moderate risk
Methylphenidate Hydrochloride Tablets
Presence of Foreign Substance: Metal embedded in a tablet.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Other recalls by Teva Pharmaceuticals USA
All 2017 recalls
Class II · Moderate risk
traZODone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk
Claravis (isotretinoin capsule, USP)
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
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