Teva Pharmaceuticals Methylphenidate Hydrochloride Tablets Recall

Why it was recalled

Failed Dissolution Specifications: Low out of specification results for dissolution.

Product description

Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01.

Lot numbers, UPCs & expiration codes

Lot Number # 1156086M, Exp 08/18

Where it was sold

Nationwide in the USA and Puerto Rico

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0052-2018
Classification: Class III
Status: Terminated
Recall initiated: Oct 17, 2017
FDA report date: Nov 1, 2017
Quantity: 58,292 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Teva Pharmaceuticals USA

Original FDA data

Every field from FDA enforcement report D-0052-2018, exactly as published.

Show all FDA fields

City: North Wales
State: PA
Status: Terminated
Country: United States
Event ID: 78308
Address: 1090 Horsham Rd
Code information: Lot Number # 1156086M, Exp 08/18
Postal code: 19454-1505
Report date: Nov 1, 2017
Product type: Drugs
Recall number: D-0052-2018
Classification: Class III
Recalling firm: Teva Pharmaceuticals USA
Product quantity: 58,292 bottles
Termination date: Apr 12, 2018
Reason for recall: Failed Dissolution Specifications: Low out of specification results for dissolution.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01.
Distribution pattern: Nationwide in the USA and Puerto Rico
Recall initiation date: Oct 17, 2017
Initial firm notification: Letter
Center classification date: Oct 26, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0052-2018, published Nov 1, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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