Teva Recalls Methylphenidate Hydrochloride Tablets Due to Dissolution Failures
Teva Pharmaceuticals USA is recalling 58,292 bottles of Methylphenidate Hydrochloride Tablets USP, 20 mg, because they failed to meet dissolution specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as an FDA Class III recall, which is defined as unlikely to cause adverse health consequences. The issue is a quality control failure (dissolution) rather than a direct safety hazard like contamination or mislabeling.
Plain-English summary
Teva Pharmaceuticals USA is recalling 58,292 bottles of Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles. The product is prescription-only and was manufactured by Watson Laboratories, Inc., in Corona, CA. The specific lot number is #1156086M with an expiration date of 08/18.
The recall was initiated because the tablets failed to meet dissolution specifications, resulting in low out-of-specification results. This means the tablets may not dissolve at the required rate, which could affect how the medication is absorbed in the body.
The affected product was distributed nationwide in the USA and Puerto Rico. Consumers and healthcare providers should check their inventory for this specific NDC (0591-5884-01) and lot number. If found, the product should be returned to the pharmacy or distributor for replacement or refund.
The recalled product
- Product
- Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 58,292
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number # 1156086M
- Exp 08/18
Distribution
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